“PSM applauds those Senators who are committed to keeping our drug supply chain secure and our patients safe. Although the United States has the most secure drug supply chain in the world, recent incidents such as the discovery of fake Avastin prove we must remain ever vigilant. Importation would erode the FDA’s ability to regulate prescription medicines and open the door for more criminals to operate bogus online pharmacies that prey upon our citizens. Indeed, FDA Commissioner Hamburg herself has stated that the FDA lacks jurisdiction to control other nations’ supply chains. Today, the Senate rightly voted to keep patient safety first.

“Instead of undermining nearly two decades of progressive drug safety policy by allowing importation, Congress should focus its energies on further strengthening our nation’s drug supply so that dangerous and potentially deadly counterfeit medicines become a thing of the past. PSM remains committed to the fight against unsafe medicines, and we and our partners will continue to vigorously oppose any legislation that threatens Americans and our drug supply.”

“The commitment to combat rogue online pharmacies made at this past weekend’s G8 Summit reinforces the need to work across borders to ensure that drug counterfeiters are deprived of any opportunity to prey upon innocent patients. PSM applauds this bold step and looks forward to working closely with the U.S. government and governments across the world in leading this effort. 

Drug counterfeiters are among the lowest form of criminals. They disproportionately target our poor and elderly citizens, those most likely to fall victim to their promises of cheap medicines. Unfortunately, there have been far too many instances in recent years of patients becoming sick or dying after purchasing what they thought were legitimate prescription drugs. By tackling the issue head on, President Obama and the other G8 leaders are putting these criminals on notice. PSM stands with world governments in the fight to stop this growing global health risk.

Recognition of the dangers posed by counterfeit medicines must continue to be top of mind, especially as the U.S. Congress considers the legalization of prescription drug importation that will only open the door for more criminals peddling fake and potentially lethal drugs to prey upon our citizens. Just the opposite, it’s critical that we double down on our shared efforts to directly address the counterfeit issue. Focusing the collective energy of government and the private sector on eliminating this growing epidemic will do the most to help ensure the safety of patients worldwide.”

About PSM:

Comprised of more than 60 non-profit organizations, the Partnership for Safe Medicines is a public health group committed to the safety of prescription medicines and protecting consumers against counterfeit, substandard or otherwise unsafe medicines.  PSM can be found on Facebook (http://www.facebook.com/SafeMedicines), Twitter (@safemedicines), and the web at www.safemedicines.org.

Media Contact:

Demetrios Karoutsos
demetrios@safemedicines.org
+1-202-617-3075

Leading Health Care, Business, Labor and Advocacy Groups Join
Together to Oppose Drug Importation as Part of the Prescription
Drug User Fee Act (PDUFA)

Importation Undermines Drug Safety Protocols, Could Lead to Influx of Dangerous Counterfeit Drugs

Washington, D.C. (May 21, 2012) – In a letter sent today to members of the U.S. Senate, the Partnership for Safe Medicines (PSM), a public health group comprised of more than 65 organizations committed to the safety of prescription drugs and protecting consumers against counterfeit, substandard or otherwise unsafe medicines, joined with leading patient, health care, business and advocacy groups in strongly opposing any amendments that would permit legal importation as part of the Prescription Drug User Fee Act (PDUFA). If allowed to move forward, importation would unnecessarily expose patients to increased risk of dangerous and potentially life-threatening counterfeit medicines making their way into the United States.

Among the organizations included in the letter: the American Pharmacists Association, the Kidney Cancer Association, the National Association of Manufacturers, the Pharmaceutical Industry Labor Management Association (PILMA) and the U.S. Chamber of Commerce.

“Despite the United States having the most secure drug supply chain in the world, recent incidents such as the discovery of fake Avastin prove we must remain ever vigilant,” said PSM Chairman Marvin D. Shepherd, PhD. “Contrary to claims made by importation advocates, there is no regulation for products trans-shipped through ‘safe’ countries such as Canada and the United Kingdom. Americans would be put at great risk and importation would erode the FDA’s ability to regulate prescription medicines, opening the door for more criminals to operate bogus online pharmacies that prey upon our citizens.”

PSM believes legalizing importation would break a crucial link in the supply chain, as the FDA has no legal jurisdiction over foreign supply chains. Furthermore, the number of rogue online pharmacies would likely skyrocket, as an unregulated importation market would give criminals carte blanche to prey upon American citizens.

“Instead of undermining nearly two decades of progressive drug safety policy by allowing importation, the Senate should soundly reject any and all importation amendments,” said Shepherd. “PSM remains committed to the fight against unsafe medicines, and we and our partners will continue to vigorously oppose any legislation that threatens Americans and our drug supply.”

PSM’s Board includes Dr. Marv Shepherd; Bryan A. Liang, MD, PhD, JD, Vice President, Partnership for Safe Medicines, Executive Director, Institute of Health Law Studies, California Western School of Law and Director, San Diego Center for Patient Safety, University of California San Diego School of Medicine; and Thomas T. Kubic, Treasurer, Partnership for Safe Medicines, President & CEO, Pharmaceutical Security Institute and Deputy Assistant Director, FBI (Ret.)

Read the joint letter from PSM, its members and allies to the Senate here.

Learn how to comparison shop safely
on certified online pharmacies.

Two Israeli citizens pleaded guilty to smuggling counterfeit and misbranded drugs in the US.  

The Food and Drug Administration Office of Criminal Investigations (OCI) explained that "both men operated an Internet business in Israel that used multiple websites, including 'allpillsrx.com,' 'newpharm.net,' and others to illegally sell large amounts of prescription drugs to U.S. purchasers, including approximately 9,029 separate drug shipments...generating approximately $1,475,363 in gross proceeds."

Said OCI, "Carmi and Dahan were prosecuted after the Government conducted a series of 'undercover' purchases of drugs with some of defendant’s Internet websites, and repeatedly ordered various prescription drugs and controlled substances...without providing a valid prescription from any qualified health care professional."

Carmi and Dahan shipped drug packages to addresses located in the Eastern District of Missouri containing various prescription drugs, typically containing drugs imported from China and India.

Laboratory testing of the drugs received revealed that these drugs were counterfeits and were also "sub-potent, containing less than the amount of active drug ingredient than what was specified in the labeling for the drugs," reported OCI.

"Counterfeit pharmaceuticals pose a very serious threat to our public health and safety," said Gary Hartwig, special agent in charge of Immigration and Customs Enforcement's Homeland Security Investigations (“HSI”) Chicago office. "People shouldn't have to put their health in jeopardy because they bought a prescription drug online that is fake, substandard, tainted or untested. HSI will continue to work with our law enforcement partners to keep imposter drugs off the street and aggressively pursue those who place consumers at risk for their own financial gain."

Benny Carmi admitted to introducing misbranded prescription drugs into interstate commerce, smuggled prescription drugs into the U.S., and sold counterfeit prescription drugs. Carmi was sentenced to ten months of imprisonment, fined $30,000, and forfeited $50,000.

Moshe Dahan admitted to smuggling prescription drugs into the U.S., and sentenced to one year of probation, a $15,000 fine and a forfeiture of $15,000 to the U.S.

Purchasing medication from fake online pharmacies is not necessary in order to save money. Medicines can be comparison shopped at VIPPS online pharmacies, which are certified as safe for American consumers by the National Association of Boards of Pharmacy. Learn more about comparison shopping and safe savings.

By S. Imber

The Connecticut warehouse break-in required the criminals to slide through a whole cut in the warehouse roof, down a rope, in order to steal 49 pallets of antidepressants and antipsychotics on a tractor trailer truck, reports the Wall Street Journal.  

The brothers, Amaury Villa, 37, and Amed Villa, 46, were videotaped looking into the warehouse on the night of March 13, 2010.  Both men were indicted on federal conspiracy and theft charges by a federal grand jury in New Haven, Connecticut. Additionally, Amaury Villa and ten other men were charged in federal court in Miami with conspiracy to sell stolen goods, including medicines.  

Said David Fein, the U.S. Attorney in Connecticut, "We believe that a prolific cargo theft ring has been dismantled."  

By S. Imber

Click on image for full graphic.

The Top 9 Health Risks Women Face From Counterfeit Medications

Disfiguration has been caused by Counterfeit Botox™ containing questionable inauthentic ingredients, such as cooking oil, which caused abscesses, scarring and kidney failure in victims. A New Zealand woman was hospitalized for 6 weeks after being injected by an unknown substance by a friend who bought fake Botox online.

Uterine infection is the likely result of counterfeit IUDs, a “nationwide problem” says the FDA. Trying to save money by purchasing fake IUDS has exposed women to unsanitary items that could cause uterine infection, complications, and unwanted pregnancy.

“Unapproved products bring a lot of unknowns into the equation,” said FDA compliance officer Kathleen Anderson. “An internet ad may claim to sell IUDs made in Canada, but there’s no way to be sure. They might have been made anywhere in the world and in unsanitary or undesirable conditions.”

Diabetic shock and coma are the consequence of counterfeit insulin pen needles, fake diabetes test strips, and falsified diabetes medications. Incidents of these have all been tested and found by government agencies. The Mayo clinic lists diabetes as one of the top killers of women.

Resold, or counterfeit test strips are likely to give incorrect readings, and cause treatment failure. Watch out for old test strips sold online.

Malaria is particularly deadly to pregnant mothers and their unborn children. While malaria is curable with authentic artemisinin combination therapies, fake anti-malarial drugs have become a crisis in southeast Asia.

According to the Center for Disease Control, malaria is at risk to re-emerge in the US, especially in the southern states. Counterfeit antimalarial drugs have been found in Africa, Southeast Asia, East Asia and even the Solomon islands.

Chronic lower respiratory disease is one of the top killers of women, according to The Mayo Clinic. Counterfeit antibiotics and flu vaccines, both found by investigators in fake pharmacies, can turn curable conditions into chronic life-threatening conditions like bronchitis and emphysema.

Worldwide, vaccines have been subject to counterfeiting, including the inoculation 60,000 people in Niger with fake meningitis vaccines, and 1,400 people in Texas injected with fake flu vaccine.

Post-partum hemorrhage, the leading cause of maternal mortality according to the American College of Obstetricians and Gynecologists is treatable with Misoprostol…unless it’s fake. Counterfeit Misoprostol, found widely worldwide could cost a mother’s life before the mistake is discovered.

Each year, 45 million women deliver without a skilled attendant, a situation in which the greatest number of maternal deaths occurs," says World Health Organization experts, adding that "women can safely self-administer misoprostol orally to effectively prevent postpartum hemorrhage."

Breast cancer, lung cancer, skin cancer and colorectal cancer are the top cancers killing women, according to the Mayo Clinic. Fake cancer drugs have been found in three separate incidents in the U.S. in the past two years. More than 50 cancer clinics have been warned about purchasing fake cancer drugs by the FDA just this year alone.

Osteoporosis is treated with risedronate. A fake Canadian online pharmacy sent US customers seeking to treat osteoporosis counterfeit risedronate tablets instead of the real medication. FDA agents intercepted and tested purchases, finding them to “not contain the proper amount of active ingredients.”

Not only did consumers get counterfeit medications, they also have been extorted by fake FDA agents, who demanded “fines” of $1,300 to $100,000 to be sent to the Dominican Republic via Western Union.

Heart disease is the top killer of women. Medications to prevent heart disease like smoking cessation aids, weight loss medication, and statins have all been purchased in counterfeit form online. Some fakes contained dangerous substitute ingredients that masked symptoms with the possibility of life-threatening side effects including stroke.

Buying medication from random strangers online is a great way to get a dangerous counterfeit containing controlled substances like Sibutramine, which can cause high-blood pressure, seizures, tachycardia, palpitations, heart attack or stroke.

Attorney General Eric Schneiderman said, "The ringleaders of this complex scheme not only cheated the Medicaid program out of millions of dollars, but preyed on some of New York’s most vulnerable patients just to make a quick buck," reports the New York Post.

An investigation code-named "Operation Black Market Meds" shut down an allegedly illegal operation that distributed HIV prescription drugs through MOMs pharmacy, a high-volume pharmacy with satellites in Suffolk County and Brooklyn.  The parent company, Allion Healthcare, has also been accused of dispensing illegally obtained medications to Medicaid recipients and billing Medicaid for the unsellable drugs.

The Attorney General's office reports that "The scheme endangered patients by exposing them to drugs of unknown origin and potency, and in some cases, drugs that were mislabeled or potentially expired."

The indictment and forefeiture complaint charges that Glenn Schabel, supervising pharmacists and compliance officer for MOMS pharmacy, accepted bribes to purchase ove $275 million worth of black market HIV medications for a number of shell companies.  The medications may have included unused pills that had been previous dispensed to individuals, as well as stolen and expired medications.  

The shell companies were allegedly controlled by Stephen Manuel Costa, a 27 year old Florida resident who is alleged to have furnished millions of black market HIV medications to MOMS patients, while Allion, under the direction of Shabel  billed Medicaid for them, allegedly knowing they were illegally obtained and fraudulent.

Attorney General Schneiderman's office also alleges that Ira Gross, another licensed pharmacist, brokered the sale of the illegally diverted drugs between Schabel and Costa, and a fourth defendant, Harry Abolafia created false invoices.  Schabel, Gross and Abolafia all allegedly received $5.3 million, $21.2 million, and $1.4 million, respectively for their roles in the distribution of diverted, fraudulent medicines to patients.

Says Attorney General Schneiderman's office, "In these types of black market operations, drugs are obtained from a variety of sources, and can be rebottled with fake labels and serial numbers, broken seals, or contain different medications than what’s indicated on the labels. As a result, patients are exposed to potential adverse drug interactions, overdoses, or a decline in their condition by not getting the treatment they were prescribed. "

The Attorney General's office used telephone wiretaps to intercept a delivery of over $1 million worth of fraudulent prescription HIV medications from one of Costa's companies to the distribution center of MOMs pharmacy.  Additionally, the office seized millions of dollars in assets through a forfeiture complaint.  

The Food and Drug Administration has sent warning letters to more than 50 U.S. doctors and medical clinics that may have purchased counterfeit cancer injectable medication. Originally the FDA sent 19 medical practices warnings in March. The FDA warns the physicians that purchasing from foreign or unlicensed medicine suppliers puts patients at risk of exposure to potentially fake, contaminated, ineffective and dangerous medication.

FDA official Dr. S. Leigh Verbois, Acting Deputy Director of the Division of Supply Chain Integrity asked physicians in 13 states to avoid using the fake medications in letters dated April 5, 2012.   

The doctors who received these letters reside in Alabama, Arizona, California, Florida, Illinois, Maryland, Michigan, Nevada, New Jersey, North Dakota, Oregon, South Carolina, Tennessee, Texas and Washington. 

“…your medical practice purchased multiple medications from a foreign distributor named Richards Pharma, also known as Richards Services, Warwick Healthcare Solutions, or Ban Dune Marketing Inc. (BDMI). Many of the products sold and distributed by this distributor have not been approved by the FDA,” said Dr. Verbois’ letters.   

“The Agency has learned that one of the products distributed by Richards Pharma is a counterfeit version of Roche’s Altuzan 400mg/16ml. Even if the version had not been counterfeit, Altuzan itself is not approved by FDA,” the letters continue.  

“Other drug products obtained from Richards Pharma, Richards Services, Warwick Healthcare Solutions, BDMI, or other foreign or unlicensed suppliers may be from unknown sources, may have unknown ingredients, may be counterfeit, or may not have been manufactured, transported or stored under proper conditions as required by U.S. law, regulations, and standards.  

“Purchasing prescription drug products, such as injectable cancer medications, from foreign or unlicensed suppliers puts patients at risk of exposure to drugs that may be fake, contaminated, improperly stored and transported, ineffective, and dangerous. In virtually all cases, purchasing unapproved prescription drugs from foreign sources violates the Federal Food, Drug, and Cosmetic Act and is illegal.”

The FDA letter goes on to point out that the medication counterfeited is not in short supply, and points back to an FDA Drug Integrity and Supply Chain Security memo released to physicians in January 2012.  The letter states that the FDA knows that some physicians are purchasing unapproved injectable cancer medications, and reminds them that importing medications from foreign sources is in violation of the Federal Food, Drug and Cosmetic Act (FDCA).  

"FDA is aware of promotions and sales of unapproved injectable cancer medications direct-to-clinics in the U.S, which most likely were administered to patients," states the memo.

Dr. Margaret Hamburg, Commissioner of the FDA, wrote in the FDA's blog, "For patients with cancer, combating the disease is difficult enough. But to learn that the cancer drug you were taking to save or prolong your life might be nothing but a counterfeit is unthinkable."

One among those that received the recent letters was Dr. Isabella Martire, of Laurel, MD who pleaded guilty to introducing a misbranded drug into interstate commerce in August, 2011.  Dr. Martire admitted to using drugs not approved by the FDA to treat cancer patients in order to save almost $800,000 per year.   She admitted to purchasing $200,000 of misbranded drugs and then sought reimbursement from public and private health insurance plans for the actual costs.  

Tom Kubic, President and CEO of the Pharmaceutical Security Institute warned that doctors are integral stakeholders in a safe and secure supply chain, "If you're a doctor running a U.S. clinic and you're willing to dispense medicines with French packaging, what good is an RFID tracker? You've got to have some integrity on both ends."  

Medical professionals can learn about sourcing medicine safely by reading the Partnership for Safe Medicines’ LEADERS guide for doctors, nurses and pharmacists.

By S. Imber

Washington, D.C. (May 2, 2012) – Asthmatics suffer from both chronic shortness of breath that if treated inconsistently can lead to serious illness and the burden of daily medication which requires conscientious treatment as well as expense.

With this double burden, asthmatics may wonder if there is a reasonable cost solution to the chronic condition.  Shopping online for medication can be both a timesaver and a cost saver, if done safely from VIPPS certified websites.  By price comparing at VIPPS certified online pharmacies, asthmatics can save up to 52% of the costs on their inhaled corticosteroid medications alone.  

“Purchasing medication online from a VIPPS pharmacy is a safe way for Americans to price compare and find better deals on their medication.  Using a VIPPS pharmacy insures that the patient isn’t getting ripped off with a counterfeit medication, a potentially life threatening result,” warns Dr. Marv Shepherd, Director of the Center for Pharmacoeconomic Studies at the University of Texas at Austin's College of Pharmacy.

Indeed, in 2011, a British businessman was convicted of importing and selling counterfeit asthma inhalers that stopped dispensing medication after 1/3 of their doses had been dispensed.

“The horror of the fake inhalers is that asthmatics believed they were inhaling daily medication, but instead it was just compressed air,” said Dr.  Shepherd.

Shopping for inhaled corticosteroids using the National Association of Boards of Pharmacy’s list of VIPPS pharmacies, the Partnership for Safe Medicines staff found that the medications listed by the by the American Academy of Allergy, Asthma and Immunology’s Allergy & Asthma Medication Guide could vary in price by up to 52%.  For example, popular children’s inhaler medication, Advair Diskus 100/50, could be purchased from the sampling of VIPPS approved online pharmacies from prices ranging between $101.53 and $201.64.

While the above example is only from a sample of five VIPPS approved online pharmacies available at http://www.nabp.net/programs/accreditation/vipps/find-a-vipps-online-pharmacy/, there are 30 different online pharmacies available that meet US federal and state laws and regulations.

“Purchasing medications from VIPPS online pharmacies is a great way to shop around and find better deals on medication,” said Dr.  Shepherd.

Dr. Shepherd  went on to point out that for families that struggle to afford even the discounted medication available on line, the next place to turn is to nonprofit and government programs that provide assistance to the needy. 

The Partnership for Prescription Assistance, NeedyMeds, Rx Outreach, Together Rx Access, the National Conference of State Legislatures, and Medicare all have prescription medication assistance programs for the financially disadvantaged. 

“These programs provide prescription assistance to those in need,” said Dr. Richard J. Sagall, President of NeedyMeds.  “There is no reason to risk your health by buying from an overseas online pharmacy that is not VIPPS approved.  No matter how good the deal seems, when the inhaler doesn’t work, your lungs won’t either.”

Simon Martin Hickman, 52, from Manchester, was sentenced to two years imprisonment in June 2009 following a conviction of selling and supplying fake and unlicensed medicines, as well as money laundering £1.4 million, announced the MHRA.

However, investigators uncovered a money laundering trail that followed over thirty bank accounts in six foreign jurisdictions, including the development of an online casino based in Malta. Using the Proceeds of Crime Act (POCA), the financial investigators revealed that Hickman pocketed £15.4 and ordered him to turn over £14.4 within six months or receive 10 years in prison, reports Securing Pharma.

Hickman was charged and convicted of selling prescription steroids illegally in 1998, and jailed for ten months. After that he set up MSH World Traders, an online business that sold counterfeit medications including Kamagra, an unapproved drug that contains sildenafil citrate, a regulated ingredient that can be dangerous if taken without the supervision of a physician.  UK investigators began looking into his illegal business in 2005, making a test purchase of pills in 2006 that determined he was selling counterfeits. Despite an injunction to shut down his website in 2007, he continued to trade, and was jailed for violating the injunction, prior to his 2009 conviction, reports the Daily Mail.

Hickman was not cooperative with the investigation into his illegal profits, breaching a restraining order and selling assets without court approval.  Officials found 30 bank accounts located in Malta, Holland and the Cayman Islands, reports TNT Magazine.

While Hickman sold dangerous counterfeits on line, it is possible to buy medication safely online.  Learn more from "Save Money Safey from Online Pharmacies."

This confiscation cooincides  with MHRA's announcement that it has engaged a new strategy to reduce the risks to patients in the UK from the threats of counterfeit medicines while increasing the pressure on criminals, focusing on prevention, incident management and investigation.

Said Nimo Ahmed, MHRA acting Head of Enforcement, "The UK market for medicines is immense and is estimated to be worth around £8,000 million. Combating the real and present threat posed by counterfeit medical products continues to remain a priority for the MHRA. We are committed to working closely with international partners and providing leadership in dealing with this issue to protect public health and maintaining public confidence in the way we obtain our medical product."

By S. Imber

The objectives of the workshop are

1. To discuss the breadth of current issues, regulations and solutions.
2. Obtain additional  input for USP General Chapter <1083>.
3. Identify opportunities for USP's role in supply chain integrity for assuring the quality of medicines.
4. Foster conversation among stakeholds in the pharmaceutical industry on strategies to improve supply chain integrity.

General Chapter <1083> has been posted in advance of publication to Pharmacopeial Forum in order to provide review and comment before the workshop.  

Those interested in pharmaceutical supply chain issues, including regulators, wholesalers, repackagers, logistics professionals, pharmacists, and physicians can register to attend the two day program.

Says USP,  "Supply chain integrity involves minimizing risks that arise anywhere along the supply chain, including sourcing pharmaceutical raw materials, manufactured medicinal ingredients, the finished dosage form in its packaging, and distribution to consumers. The goal of good distribution practices is to present sound business practices that help deter unauthorized access to and manipulation of these materials, and to provide effective means for detecting adulterated drug components and drug products (finished medicines) so that they do not enter the supply chain."

The Supply Chain Integrity Workshop will be held on May 22 and May 23, 2012 at USP's Rockville, MD headquarters at 12601 Twinbrook Pkwy.  

In February, Americans were reminded of our interconnectivity to the global marketplace, when the FDA announced a counterfeit version of a cancer medication was found in the U.S.  The authentic medication is made in California, and then distributed to U.S. hospitals and clinics by one of three authorized distributors.  In the case of the counterfeit medication, it travelled around the world, crossing four continents, before arriving in the U.S.  The manufacturer remains a mystery. What we do know is that the medication contained no active ingredient, and was a combination of starch, salt, paint thinner and other common chemicals.

Will globalization so alter the American experience that patients here will face the counterfeit medicine challenge which now confronts many African nations?

African patients question whether or not their medications, some required to cure the most persistent diseases, will contain active pharmaceutical ingredients.  Malaria Journal recently published a study that found fake artemisinin, the most effective antimalarial drug available, in eleven African countries.  The fake antimalarial meds contained either the wrong mixture of active ingredients or insufficient medication to control the disease.  While malaria is curable, the World Health Organization estimates that more than half a million people died of malaria in 2010, mostly African children.  How many of these children died of a curable disease because they were unwittingly given counterfeit medication by loving parents?  We don’t know.  But we do know that the parasite that causes malaria is developing resistance due to its exposure to fake medications with less than correct dose to achieve a therapeutic result.   Incurable malaria due to counterfeit medicines may kill even more children in the future.

FDA Special Agent Nancy Kennedy once said, “Make no mistake, it’s about the money,” when describing the people she’s investigated for counterfeit medications.  These people are organized, and their concern is to make money irrespective of who dies.  One such criminal, Manuel Calvelo, a Belgian, sold $1.4 million worth of misbranded and counterfeit drugs, as well as controlled substances to Americans. Pleading guilty to charges in January 2011, he admitted that for three years he operated websites pretending to be pharmacies and selling fake drugs.  He’s just one drop in the bucket of global criminals that operate beyond U.S. borders to impact the lives of Americans.  Future Manuel Calvelos should beware because in the coming weeks, the U.S. Congress is considering increasing the penalties for those convicted of trafficking in counterfeit medicines.

What can Americans do to prevent counterfeit medications from destroying the lives of so many?  Firstly, we must recognize counterfeit drugs are in the market in many countries.  In 2010, they were found in over 100 countries. 

And secondly, avoid these counterfeits yourself by doing four things:

1. Avoid online drug sellers purporting to be pharmacies. 
2. Only purchase medications from within the closed, secured drug supply chain. 
3. Look for either the National Association of Boards of Pharmacy’s “VIPPS” approved online pharmacies or buy your medications from bricks and mortar pharmacies. 
4. Follow the recommendations from The Partnership for Safe Medicine’s consumer handout, ‘Save Money Safely On Your Prescriptions from Online Pharmacies.”       

You’ll keep yourself healthy, and you’ll help cripple the international gangs that destroy the lives of so many worldwide.

XROCK INDUSTRIES, LLC Issues a Voluntary Nationwide Recall of X-ROCK, a Product Marketed as a Dietary Supplement to Support Male Sexual Performance, Due to Unlisted, Potentially Hazardous Ingredient

XROCK INDUSTRIES, an independent distributor of the X-ROCK products, is conducting a user level voluntary recall of certain supplement products sold by XROCK INDUSTRIES under the brand name of X-ROCK.

Finished product of X-ROCK for Men was tested and preliminarily found to contain an analogue of an ingredient in an FDA-approved drug.  Analytical tests conducted by the Food and Drug Administration (FDA) of X-ROCK for Men concluded that the products contained sildenafil and hydroxythiohomosildenafil.  Hydroxythiohomosildenafil is an analogue of sildenafil.  Sildenafil is the active pharmaceutical ingredient in an FDA-approved drug that is used to treat erectile dysfunction (ED).

Hydroxythiohomosildenafil is close in structure to sildenafil and is expected to possess a similar pharmacological and adverse event profile.  These undeclared active ingredients pose a threat to consumers because sildenafil and hydroxythiohomosildenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and lower blood pressure to dangerous levels.  Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.  ED is a common problem in men with these conditions, and they may seek products to enhance sexual performance.  Additionally, hydroxythiohomosildenafil, like sildenafil, may cause side effects, such as headaches and flushing. 

All codes of X-Rock for Men, within expiration, are included in this recall.

XROCK Industries has not received any reports of adverse events related to this recall.

XRock for Men was distributed in single blister cards. See attached photograph. XRock for Men was distributed Nationwide to wholesalers and retail to the consumer via internet orders from www.XRockMe.com, www.XRockHim.com and www.XRockFlorida.com, and by telephone.

Customers who have this product in their possession should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking this product.

The Company is advising consumers to return any unused X-ROCK, for a refund of the full purchase price, to the retail location from which it was purchased or to the Company directly if it was purchased from the Company as a part of its Direct Response Program. Consumers can call 877-976-2563 Monday through Saturday 9am-9pm EST to receive instructions for returning the product. Additional information is provided on the Company’s website at www.XROCKME.com.

Any adverse events or quality problems experienced with the use of this product may be reported to the   FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax:

• Online: http://www.fda.gov/medwatch/report.htm
• Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: http://www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.
• Fax: 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

The Company is taking this voluntary action because it is committed to providing accurate information on the label of its products and because it is always concerned with the health of persons who have consumed this product. The Company is reviewing the procedures and policies of all firms involved with the manufacture of the product to ensure that there will be no future issues with regard to X-ROCK’s composition and labeling. The Company is working closely with the FDA in the recall process and is committed to the quality and integrity of its products. It sincerely regrets any inconvenience to consumers and its other customers and the incomplete X-ROCK labeling information.

The National Association of Boards of Pharmacy has released year end data on safe online pharmacies showing the rise of the “affiliate network.”

While the number of legitimate online pharmacies safe for Americans remains at 4% of all, the growth of fake online pharmacies out of compliance with U.S. pharmacy laws and practice standards appears to be strongly linked to the spread of underlying source organizations called “affiliate networks” that proliferate the internet with copies of their websites.

The NABP has published a report, “Internet Drug Outlet Identification Program Progress Report for State and Federal Regulators: January 2012” which identifies 8,456 so-called online pharmacies that are out of compliance with U.S. pharmacy laws and practice standards. Of those, 8,265 appear to be network affiliated, 98%.

The NABP staff identified websites that use the same phone number, physical address, domain name registrant, website design or web business name as those being part of a rogue affiliate network. A rogue affiliate network is a group of internet drug outlets operated by one organization, which are frequently operated outside of the U.S.

“The common perception in America is that a discount retailer out there on the internet can, because of lower costs of business elsewhere, provide medication at below U.S. market rates. What they don’t know is that the medications are all coming from the same counterfeiters in India and China, and that a giant conglomerate of organized crime runs these hundreds of millions of websites that advertise as if they were ‘mom and pop’ small pharmacies on the internet,” said Carmen Catizone, NABP’s Executive Director.

Indeed, the affiliate networks behind 98% of the NABPs unapproved list are among the 30 identified by researchers at the University of California San Diego. Those 30 affiliate networks with names like “RX-Promotion” and “World Pharmacy” control over 346,000,000 URLs using 54,220 domain names.

Says Tom Kubic, President and CEO of the Pharmaceutical Security Institute, “Don’t support counterfeiters! You can avoid dealing with crooks by following the common sense guidelines found in the Partnership for Safe Medicine’s consumer handout, ‘Save Money Safely On Your Prescriptions from Online Pharmacies.”

To learn mroe about how fake pharmacy affiliate networks operate, read the series entitled "Pharma Wars" by investigative reporter Brian Krebs.

Download a copy of the affiliate network graphic.

By S. Imber

Partnership for Safe Medicines Carl L. Alsberg, MD, Fellow, Timothy Mackey, UCSD PhD student and senior research associate, has been awarded one of four Interdisciplinary Scholar Awards at University of California San Diego's university-wide competition.  He was awarded the accolade for his work on illicit online drug sellers and social media which he presented during the award ceremony in a speech entitled, "Risks Assessment of Social Media Advertising for Illicit Online Pharmacies."

He is the co-author of a number of research articles on online media and medication. With Dr. Bryan Liang, he has written Online Availability And Safety Of Drugs In Shortage: A Descriptive Study Of Internet Vendor Characteristics, Direct-To-Consumer Advertising With Interactive Internet Media, Prevalence And Global Health Implications Of Social Media In Direct-To-Consumer Drug Advertising, Vaccine Shortages And Suspect Online Pharmacy Sellers, Promoting Online Drug Safety: Using Public–Private Partnerships To Deter Illicit Online Drug Sales.

Congratulations Tim!

'Natural medicine products'
in the Ver-o-Peso Marcket in Belém - Pará - Brazil
by de Paula FJ via Flickr.

Brazilian researchers for the Revista de Saude Publica have determined that counterfeit medicine seizures have tripled since 2007.  

70 incidents were reported in Brazilian authorities in 2007, doubling in 2008 with 139, more than tripling by 2009 to 233, reports Securing Pharma.  The majority of seziures took place in Parana, Santa Catarina and Sao Paulo, all of which are states in southeastern Brazil.

Using Federal Criminal Police reports, researchers discovered counterfeit cases involving erectile dysfunction (ED) medication, corticosteroids, prostaglandin products, cancer treatments and obesity drugs. Over the four year period, the frequency of ED medication seizures dropped, while other medications because more commonly found by investigators, reports Securing Pharma. The authors suggest that the counterfeit ED market has become saturated and that more vital life-saving medications may be more profitable to counterfeiters.

By S. Imber

Chrome Alum Crystals
by Paul's La via Flickr.

AFP has reported that Chinese authorities have detained 22 people accused of making drug capsules using chromium, a toxic metal that can cause kidney, liver, and blood cell damage.  13 Chinese manufactured medications have been removed from domestic circulation due to excessive chromium levels.

Zhejiang provincial authorities suspect the detainees made capsules using industrial gelatin made from discarded leather, reported Xinhua News. Chromium, also known as chrome alum, is a common ingredient in leather tanning.  

Half of the workers worked for capsule makers in Xinchang county, a major production base for pharmaceutical manufacturing, according to Xinhua. However, the industrial gelatin used in the capslues came form other factories in Hebei province in the north of China and the Jiangxi province in eastern China.

The manager of the Xueyang Glair Gelatin Factory, Song Xunjie, in Hebei, was also arrested and is suspected of arson in order to destroy evidence related to the case. Xueyang Glair Gelatin Factory is reported to supply gelatin to companies throughout China.  

The Chinese State Food and Drug Administration (SFDA) has suspected sales of thirteen types of medications confirmed to have excessive levels of chromium, including 11 traditional Chinese herbal remedies and two antibiotics, reports the Wall Street Journal. All the medications were produced domestically by companies that purchased capsules from small manufacturers in Zhejiang province.

China's SFDA is investigating and has said that the Chinese Pharmacopeia has clear standards for ingestible capsules, and that 9 laboratories were implicated in the contamination, reports the Beijing Morning News.

The medications were found to contain levels of chromium 90 times above safety standards, reports Want China Times.

"The chromium contained in the capsules is allegedly trivalent chromium, which is carcinogenic," said Cai Hong, secretary-general of the China National Pharmaceutical Packaging Association. The capsules were made from industrial gelatin, instead of edible gelatin. Cai said the excessive chromium levels were the result of low-quality gelatin used in production, reports Want China Times.

Chromium(III) salts, notably chrome alum and chromium(III) sulfate are used in tanning leather and in the gelatin emulsions in photographic film. Wikipedia reports that studies have indicated that high concentrations of chromium can lead to DNA damage, and that acute oral toxicity ranges between 1.5 and 3.5 mg/kg.  

Edible capsules cost twice as much to produce as those made from industrial materials, reports Want China Times, and the inedible base ingredient, industrial gelatin, is available at 1/5 to 1/6 the cost of edible gelatin.

Learn more about the other toxins found in counterfeit medicines.

 By S. Imber

Beware of Bogus STD Products
by The U.S. Food and Drug Administration via Flickr.

During Sexually Transmitted Disease Awareness month, public health organizations and nonprofits have raised awareness of STD and how people can get them, as well as how to treat them. But consumers also need to know that only prescription medications purchased from legitimate pharmacies can treat STD, and to avoid so-called over-the-counter cures as well as prescription medications purchased from questionable sources.

Medications purchased for STD treatment from fake online pharmacies expose patients to the risk of toxic ingredients and ineffective treatment for disease, potentially less than therapeutic doses of antibiotics, or medications that have absolutely no proven therapeutic value for curing disease.

But not only can counterfeit antibiotics and STD cures be found online, the can also be found in stores.

In May 2011 in Texas, dietary supplements with claims of being natural antibiotics were found to have caused extended diseases in the patients who received these over-the-counter substitutes for prescription medication. Antibiotics are often used to cure STDS, but fake antibiotics, whether purchased online or from stores, will not cure them.

Uneducated patients may try to treat STD themselves. Products purchased over-the-counter, or from online resources, can range from oil of oregano, which despite manufacturer claims to the contrary is not a replacement for penicillin, to actual counterfeit penicillin, purchased from a disreputable online medicine seller.

FDA expert Debbie Birnkrant, M.D., warns that trying an unapproved product can just delay treatment, causing further illness and possibly spreading infection to other people.

Dr. Birnkrant says that there are no non-prescription drugs or dietary supplements that can treat, cure or prevent STD. The only non-prescription prevention for sexually transmitted disease is the condom. However it will not cure STD.

“If you aren’t treating your STD with an FDA-approved medication, you’re not just putting your own health at risk—you could be endangering your partner,” says Dr. Birnkrant.

The FDA and the Federal Trade Commission (FTC) launched the “Fraudulent STD Products Initiative” in May 2011 in order to target over-the-counter products bought online or in retail stores that make claims to prevent, cure and treat STD. Fake STD cures can be marketed as dietary supplements as well as drugs.

The FDA evaluated the 15 STD products identified in the picture and found that the curative claims are unproven and that the use of these products can pose a threat to the public health. It has warned the manufacturers of these products and 17 others that they could face legal action if the products aren't removed the market. These products are being sold online and at some retail markets.

Dr. Marv Shepherd, Director of the Center for Pharmacoeconomic Studies at the University of Texas at Austin's College of Pharmacy, warns that going to a doctor is your best answer for treatment.

“Basically there is no OTC antibiotic treatment available for STD. As stated, a condom is preventative and probably the best prevention method available. People with a suspected STD need to see a medical practitioner and get the correct antibiotic therapy available. The over-the-counter cures available at stores and online will only relieve you of your money. Your disease will continue unabated until you are adequately treated by a medical professional,” admonishes Dr. Shepherd.

Not only will the STD stay with the patient, but inaccurate treatment and delayed medical help can increase the possibility of spreading the disease, warns the FDA.

The FDA has a list of fake STD cures they’ve identified, but reminds that any non-prescription medication that claims to cure STD is also a fake.  

The FDA and the CDC warn that patients must avoid over the counter products that claim to cure STD.  There are FDA-approved medications available to treat many STD that are available by prescription.  Be sure to see a physician if you think you may have a disease that needs treatment. 

The CDC has a compendium of common STD, treatments, and related demographic data.  Learn more about common STD at their website.

In light of the rise in counterfeit drugs, two North Dakota State University students have chosen to take an active role in educating other health care providers, as well as the public. Third year pharmacy students Nick O’Rourke and Tegan Buckley recently presented an informational poster to illuminate this problem. The poster was presented at a continuing education event in February and will be presented again at the North Dakota Pharmacists Association Annual Convention later this April.

The poster focuses on three areas: educating people about the existence of counterfeit drugs, actions being taken to overcome this problem, and the necessary steps to report counterfeit drugs to the FDA. “Right now the big thing is awareness,”O’Rourke says. "Although some counterfeits have infiltrated the US drug supply, the overall extent is very small. Most counterfeit drugs enter Americans’ homes via the internet." The poster emphasizes the importance of using VIPPS accredited sites when purchasing drugs online.

View and download the whole poster here.

Altuzan (bevacizumab): Counterfeit Product - Contains no Active Ingredient

ISSUE: FDA lab tests have confirmed that a counterfeit version of Roche’s Altuzan 400mg/16ml (bevacizumab),an injectable cancer medication, found in the U.S. contains no active ingredient. Even if the identified drugs were not counterfeit, Altuzan is not approved by FDA for use in the United States (it is an approved drug in Turkey).

BACKGROUND: Medical practices obtained the counterfeit Altuzan and other unapproved products through foreign sources, in particular from Richards Pharma, also known as Richards Services, Warwick Healthcare Solutions, or Ban Dune Marketing Inc (BDMI).  Many, if not all, of the products sold and distributed through this distributor have not been approved by the FDA. Pictures of the counterfeit version of Altuzan are shown in the FDA statement. Packaging or vials found in the U.S. that claim to be Roche’s Altuzan with lot number B6021 should be considered counterfeit.

RECOMMENDATION: Any medical practice that has obtained unapproved products, in particular from Richards Pharma, Richards Services, Warwick Healthcare Solutions, or Ban Dune Marketing Inc (BDMI), should stop using them and contact the FDA.  The products should be retained and securely stored until further notice by the FDA.

FDA is asking the public to report suspect counterfeit products and other suspect products obtained from Richards Pharma, Richards Services, Warwick Healthcare Solutions, Ban Dune Marketing Inc (BDMI), or other sources:

Call FDA’s Office of Criminal Investigations (OCI) at 800-551-3989, or   
Visit OCI’s Web site (www.accessdata.fda.gov/scripts/email/oc/oci/contact.cfm), or
Email - DrugSupplyChainIntegrity@fda.hhs.gov

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Image by
procsilas via Flickr.

Purchasing antibiotics without a prescription online can lead you to receiving antibiotics without the proper therapeutic doses or possibly no doses.  When an individual purchases antibiotics without a prescription they are negatively impacting public health in several ways. Take a vow for National Public Health Week that you'll protect yourself and your family from these risks.

1. Self-diagnosis of bacterial infection means possibly treating a virus with antibiotics which leads to increased antibiotic resistant bacteria.  Never self-diagnose bacterial infections, always see a doctor for treatment. 
 
Not only will you not treat your virus if you use antibiotics for it, but says the CDC, "Taking antibiotics when you or your child has a virus may do more harm than good. In fact, in children, antibiotics are the most common cause of emergency department visits for adverse drug events."

2. Even diagnosed bacterial infections will be treated poorly if the medication does not contain a sufficient dose of the appropriate antibiotic for the infection.  Buying from fake online pharmacies means not knowing exactly what medication you’re really getting.  Just because the medication says it’s the appropriate antibiotic doesn’t mean that it really contains it.  

Researchers and investigators have found everything from salt and sugar to heavy metals in counterfeit medications.  A weak or inappropriate antibiotic might appear to reduce symptoms, but will also increase the likelihood of antibiotic resistance.

3. Modern medicine developed antibiotics to cure deadly bacterial infections.  Not receiving appropriate treatment for your bacterial infection can mean serious illness and death.  For example, untreated pathogenic bacterial infections can lead to pneumonia, urinary tract infection, brain inflammation and coronary heart disease. The unverifiable medication you purchase from a virtual pharmacy may not treat you at all, and may cause you more harm that good.

Don’t risk your treatment by purchasing from an unverifiable online pharmacy.  Always use a VIPPS certified pharmacy online, or buy from a bricks and mortar pharmacy.  For more information on buying safely, download our consumer’s guide, "Save Money Safely on Your Prescriptions from Online Pharmacies."

By Tom Kubic, President and CEO of the Pharmaceutical Security Institute

Patients are growing concerned about reports of counterfeit drugs being provided by doctors.  In February, 19 U.S. cancer clinics were warned by the FDA that they had received counterfeit versions of a cancer drug.   Patients can protect themselves by asking their physicians questions about the origins of medicines they receive in their doctor's office.

Authentic Avastin™ is made in the U.S. and moves through a closed, secure drug supply chain to American cancer clinics.  The counterfeit medication, however, crossed four continents before arriving in the U.S. via unauthorized distributors.  Investigators are working to identify those responsible for manufacturing this fake medicine.  One thing they do know is that the fake product was not the vital, life saving chemotherapy patients expected.  The fakes contained none of the therapeutic ingredients.

How could a patient have known that the medication was fake? The chemotherapy drug is a clear liquid, so no patient with an IV in his arm would have known what ingredients were in the IV.  However a cursory look at the box the medications came in would have immediately revealed peculiarities that should have raised alarms.  Even if the patient had never seen the box before, the French and Arabic lettering on the package was a dead give-away that something was wrong!

Additionally, the package falsely states that the product was made in Switzerland, when the authentic product is made in the US.  Also, the packaging itself, the color, design and typeface used on both the box, and the interior bottle are significantly different from the authentic product.  Lastly, the manufacturer is incorrectly identified, instead of saying “Genentech, a member of the Roche Group” it says “Made in Switzerland by F. Hoffman-La Roche Ltd.^[1]”  If the patients would ask to see the medication upon every visit, the fake packaging would have alerted them to a problem with this medicine.

Sadly this is not the only US incident of counterfeit medications being foisted upon patients at doctor’s offices. 

Respiratory paralysis, near death, and disfigurement have been the unfortunate results of fake Botox treatments in the U.S in the past several years^[2][3][4].  The rise in popularity of the treatment has coincided with the importation of dangerous and deadly counterfeits.  Recently in the US, Chinese Botox fakes were found with concentrations differing by 500% than what was stated on label and that used materials that can cause severe allergic reactions.

In December 2010, a San Diego doctor pleaded guilty to injecting patients with supposed neuropeptides to cure cancer, arthritis and other chronic conditions.  However the patients were actually injected with glucocorticoid steroids that caused severe bone density loss.  Additionally he sold an undercover FBI agent so called dietary supplements for pancreatic cancer treatment which contained nimesulide, a medication unapproved by the FDA and removed from the European and Asian markets because of high rates of liver failure.

Patients can protect themselves by being curious about their medications.  Dr. Bryan Liang, Executive Director and E. Donald Shapiro Distinguished Professor of Health Law, at the Institute of Health Law Studies at California Western School of Law, exhorts, “First, if the price is too good to be true, walk away.  Second, examine the bottle being used in your treatment.  Ensure that it hasn't been used, isn't expired and that it's labeled correctly.^[5]” Protect yourself by writing down the identifying information on the medication the doctor’s office is giving you, including the serial and lot numbers.

Doctors, nurses, pharmacists and medical office workers can all keep an eye open for foreign drugs in the inventory at their work place.  Whether the medication arrives inadvertently due to supplier error, or due to  deceitful practices, anyone can report the foreign medications to the U.S. Food and Drug Administration’s Office of Criminal Investigations. 

Call them at 800-551-3989.
Or visit the OCI’s website (www.accessdata.fda.gov/scripts/email/oc/oci/contact.cfm).
Or email them at DrugSupplyChainIntegrity@fda.hhs.gov.

If you want your doctor, nurse or pharmacist to learn more about protecting your medications and the closed, secured drug supply chain, download and give them copy of the Partnership for Safe Medicine’s LEADERs Guide.

Hope: Diabetes Supplies Art
by Manny Hernandez via Flickr.

Help out the diabetic in your life by protecting them from four ways criminals can rip them off, while they’re trying their best just to get by.

The diabetic in your life has a lot to keep track of.  Constant monitoring of blood sugar levels, making sure they get the medication they need when they need it, eating well, getting enough rest, and enjoying life.

1)      Be alert to old, resold, or counterfeit test strips.  

All are likely to give incorrect readings, and therefore treat diabetes incorrectly.Watch out for the black market in diabetes test strips. People have been caught re-selling old test strips on craigslist, and online.  Be careful, if test strips are expired they will not work accurately. Additionally, counterfeit test strips have been identified by investigators that will also not work well.  Be careful, if the price seems too good to be true, it probably won’t provide the careful monitoring they need to keep diabetes in check.

2)      Be alert to counterfeit diabetes medication. 

Likewise, if you need to purchase diabetes medication, be careful and do it from a U.S. regulated pharmacy, either your corner pharmacy that has a licensed pharmacist, or online from a VIPPS pharmacy.  Counterfeit diabetes medications have been found in Africa, the Philippines, New Zealand  the Middle East and China, while counterfeit insulin needles were found in the UK.  Again, if the price seems to good to be true, it probably won’t be effective medication.

3)      Be alert to fake medicine assistance programs.

The Federal Trade Commission warns, “Emails, ads, and websites for companies that guarantee free or low-cost prescription drugs for a hefty fee upfront are scams. You are paying for information and applications that are available for free.”

If your loved one is having difficulty affording their diabetes medications, have them look into Needy Meds and the Partnership for Prescription Assistance.  These legitimate organizations can help you find more affordable medications.

4)      Be alert to fake medicine for other conditions.

When your loved one buys other medication, be sure that those medications are also authentic.  Fake medications and those that contain unapproved ingredients have been found to contain chemicals that cause side effects dangerous in diabetics.  It’s not just the diabetes drugs that get counterfeited, and they can suffer serious affects if they ingest counterfeit medications for other conditions as well.

Medication purchased online has been tested by researchers and found to contain substitute ingredients not approved by the FDA for medicinal use. Substitutes that may be cheaper may have been rejected by the FDA for use in people, or be untested, with potentially dangerous side effects and contraindications that aren't known to the public. 

ED medication purchased online and purporting to contain sildenafil citrate, vardenavil or tadalafil, instead was tested by researchers and found to contain homosildenafil, hongdenafil, aminotadalifil, xanthoanthrafil and pseudovardenafil, chemicals not FDA approved for human consumption.

Consumers who purchased Ambien, Xanax, Lexapro or Ativan instead received foreign versions of haloperidol, a powerful anti-psychotic drug. As a result, these customers needed emergency medical treatment for symptoms such as difficulty in breathing, muscle spasms, and muscle stiffness—all problems that can occur with haloperidol.

Also people who thought they were ingesting a popular, FDA approved weight-loss drug purchased online found instead they were ingesting a fake with dangerous levels of sibutramine, with serious consequences, including stroke.

IMPACT: Difficulty in breathing, muscle spasms, and muscle stiffness, high blood pressure, stroke.

Learn about heavy metals, actual poisons and toxic household ingredients found by researchers and investigators in counterfeit medications in parts 1, 2 and 3 of this series for National Poison Prevention Week.

Learn more about how to purchase medication safely online from our pamphlet "Save Money Safely From Online Pharmacies." And ask your doctor, nurse and pharmacist if they've read the six steps to becoming a LEADER in the fight to protect patient safety. 

Common household items you’d never ingest have been found in counterfeit medications. Things we use in our lives, like house paint and floor wax, which are not edible, and not meant to be ingested.

Investigators have found all of these items in counterfeit medications. Floor wax gives a nice sheen to mimic an enteric coating, brick dust and paints fake the proper color of pills, and sheet rock can be made into pills. 

Floor wax can contain formaldehyde which can cause vomiting, abdominal pain, dizziness, and in extreme cases can cause death. Brick dust can contain contain poisonous heavy metals and other chemicals. Paints can contain heavy metals for pigment, as well as hydrocarbons which are poisonous and can cause coma, blurred vision, rapid heartbeat, nausea, vomiting and diarrhea.

Paint thinner can get into bottles when it's used to peel old labels off empty bottles for re-use. Paint thinner can cause nervous system disruption, including coma, respiratory difficulty and gastrointestinal distress.

IMPACT:  Vomiting, abdominal pain, dizziness, blurred vision, respiratory difficulty, nervous system disruption, coma, death.

Learn about heavy metals and actual poisons found by researchers and investigators in counterfeit medications in parts 1 and 2 of this series for National Poison Prevention Week.

Learn more about how to purchase medication safely online from our pamphlet "Save Money Safely From Online Pharmacies." And ask your doctor, nurse and pharmacist if they've read the six steps to becoming a LEADER in the fight to protect patient safety. 

Counterfeit erectile dysfunction medication and unapproved anti-obesity medicines rimonabant and sibutramine were found, reports the MHRA.

Spanish police and Europol, arrested six people and collected approximately 300,000 doses of fake medication in a joint operation, known as ‘Operation Tribulus.’

Spanish authorities arrested four people suspected of being members of a criminal gang importing fake medicines from Asia, mainly China and Singapore, and distributing them via the internet to customers throughout Europe.

Nimo Ahmed, the MHRA’s Acting Head of Enforcement, said: “Unlicensed, untested and fake medicines can put people’s health, and even life, at risk. It is very common for counterfeit medicines to be laced with dangerous ingredients or contain the wrong amounts of active ingredients or even none at all. This means they can be ineffective or dangerous.”

Learn more about the common poisons investigators have found in counterfeit medications.

By S. Imber

Actual poison has been found in counterfeit medications that have led to the death of hundreds.  

Patients can be exposed to these poisons by buying directly from unlicensed drug sellers on the internet, or when medical professionals purchase medications from outside the secured supply chain.

INTERPOL investigators found rat poison and boric acid as ingredients in fake medication.  

Antifreeze was substituted for glycerine in cough syrup and other common medications, killing 365 people in Panama, 88 children in Haiti, 84 children in Nigeria and18 people in Guanzhou. Boric acid and antifreeze causes kidney damage and kidney failure.  

Researchers found PCBs (polychlorinated biphenyls) and benzopyrenes in fake medication purchased online. PCBs are estrogenic disrupters that may cause breast, uterine and cervical cancer and can lead to development defects. Benzyopyrenes are carcinogenic.

IMPACT: Kidney damage, kidney failure, cancer and developmental defects.

Learn about heavy metals found by researchers and investigators in counterfeit medications in part 1 of this series for National Poison Prevention Week.

Learn more about how to purchase medication safely online from our pamphlet "Save Money Safely From Online Pharmacies." And ask your doctor, nurse and pharmacist if they've read the six steps to becoming a LEADER in the fight to protect patient safety. 

There are a lot of shady ingredients that go into counterfeit medications that consumers can be exposed to by buying directly from unlicensed drug sellers on the internet, or when medical professionals purchase medications from outside the secured supply chain.

During National Poison Prevention Week, every day we're featuring a type of poison that investigators have found in counterfeit medications.

Heavy Metals: mercury, lead, cadmium, arsenic, chrome, uranium, strontium, selenium, aluminum

A Canadian suffered and died from cardiac arrhythmia caused by heavy metal poisoning from counterfeit prescription medications purchased online for routine conditions in 2006.  The coroner ruled that her medications were laced with uranium, strontium, selenium and aluminum, as well as arsenic. Her unfortunate case is not unusual.  Test results from a 2010 study showed researchers that 26% of a sampling of medications purchased from fake online pharmacies contained heavy metals or toxins including mercury, lead, cadmium, arsenic and chrome. 

POISON IMPACT:  Many heavy metals are carcinogenic or toxic to central nervous system, kidneys, liver, skin, bones or teeth.

Learn more about how to purchase medication safely online from our pamphlet "Save Money Safely From Online Pharmacies." And ask your doctor, nurse and pharmacist if they've read the six steps to becoming a LEADER in the fight to protect patient safety.