Drug Injury Watch

Risk Of Femur Fractures From Osteoporosis Drugs Fosamax, Boniva, Actonel, And Reclast Related To Number Of Years Used

2012-05-22T16:11:00-04:00

Using These Bisphosphonates More Than Three (3) To Five (5) Years May Not Only Increase Side Effect Risk But There May Be No Benefit To Most Patients

(Posted by Tom Lamb at DrugInjuryWatch.com)

In May 2012 there were medical journal articles in The New England Journal of Medicine (NEJM) and the Archives of Internal Medicine which, together, may cause millions of women to stop using the popular osteoporosis drugs Fosamax (or alendronate, its generic equivalent), Boniva, Actonel, and Reclast due to these two primary findings:

First: There is an increased risk of atypical fractures (low-stress) of the femur in women who have used these bisphosphonate osteoporosis drugs for more than five (5) years; and,

Second: For perhaps 60% to 70% of women currently using Fosamax, Boniva, Actonel, Reclast, and other bisphosphonates there is little to no benefit when these osteoporosis medications are used for more than three (3) to five (5) years.

We will start with the NEJM articles that presented the findings of an FDA review of these bisphosphonate drugs prescribed for osteoporosis and, sometimes, osteopenia (moderate to low bone density that is not low enough to be called osteoporosis) which call into question the fracture-prevention benefits of long-term bisphosphonate use:

The May 9, 2012 NEJM Perspective article from the FDA is "Bisphosphonates for Osteoporosis — Where Do We Go from Here?" (free access).
In the same edition of that medical journal is an accompanying article by Dennis M. Black, Ph.D., Douglas C. Bauer, M.D., Ann V. Schwartz, Ph.D., M.P.H., Steven R. Cummings, M.D., and Clifford J. Rosen, M.D., "Continuing Bisphosphonate Treatment for Osteoporosis — For Whom and for How Long?" (free access).

For those who do not want to read through the actual NEJM articles, we get this summary of the findings from a May 9, 2012 piece, "New Cautions About Long-Term Use of Bone Drugs", by New York Times reporter Tara Parker-Pope:

Although the concerns about the long-term safety of bone drugs are not new, the F.D.A. performed its own systematic review of the effectiveness of bisphosphonates after years of use. The agency’s analysis, which found little if any benefit from the drugs after three to five years of use, may prompt doctors around the country to rethink how they prescribe them....

The F.D.A. report offered little specific guidance about long-term use, saying that the decision to continue or stop treatment should be based on an individual assessment of risks, benefits and preferences discussed between a patient and her doctor. The agency did say that women at low risk for fracture or with a bone density near normal may be good candidates to stop therapy after three to five years, but older patients at higher fracture risk and bone density “in the osteoporotic range” may benefit from continued therapy....

The recommendations are based on findings from two industry-sponsored studies led by the University of California, San Francisco, that focused on long-term use of the drugs. A study of Fosamax, which is sold generically as alendronate, continued for 10 years, and a study of Reclast, an injectable form of the drug zoledronic acid, continued for six years. According to the F.D.A. analysis, both studies showed significant reductions in fracture risks during the first three to four years of use but little or no benefit with longer use.

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Next, we take up the the two Archives of Internal Medicine articles concerning the Swiss study which found that bisphosphonate therapy, i.e., use of Fosamax, Boniva, Actonel, or Reclast, appears to be associated with an increased risk of atypical fractures of the femur, and may be driven by the duration of treatment, that were published online May 21, 2012.

For the take-away from these two medical journal articles we draw upon this MedPage Today report, "Bone Drug Link to Uncommon Breaks Confirmed":

... Meier's group identified patients admitted to their level I trauma center with a fracture of the subtrochanteric femoral shaft area between 1999 and 2010 and divided them into two groups.

One arm consisted of patients with atypical fractures, defined as "a transverse or short oblique fracture line originating at the lateral femoral cortex between the lesser trochanter and the distal metaphysis."

Another arm was made up of patients with common or classic fractures that were in the same location as atypical fractures, but with spiral, wedge, segmental, or complex irregular appearance.

They also established a control group of people who did not have a history of femoral fracture....

After adjustment for potential risk factors, including vitamin D status, corticosteroids, proton pump inhibitor use, sex, and age, the authors found that any bisphosphonate use was associated with an [odds ratio (OR)] of 69.1 (95% CI 22.8-200.5) for an atypical fracture versus a classic fracture.

When categorized by duration of treatment compared with no treatment, the OR for an atypical fracture compared with a classic fracture was:

OR 35.1 for less than 2 years of treatment

OR 46.9 for 2 to 5 years

OR 117.1 for 5 to 9 years

OR 175.7 for more than 9 years

When comparing the atypical-fracture group with the control group, the authors reported that bisphosphonate treatment was associated with an OR of 35.2 (95% CI 15.9-155.9, P<0.001).

No doubt these two sets of medical journal articles published by the NEJM and the Archives of Internal Medicine in May 2012 will serve to generate further studies about the efficacy and safety of Fosamax, Boniva, Actonel, Reclast, and other bisphosphonate drugs.

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Merck Funded Study Says There Is No Blood Clot Risk With NuvaRing, While BMJ Medical Journal Article Reports A 90% Increased Risk

2012-05-16T15:03:00-04:00

Perhaps These Conflicting Findings As Regards Serious NuvaRing Side Effects (PE, DVT, Stroke) Will Prompt FDA To Convene An Advisory Committee Meeting To Consider Safety Of This Vaginal Ring

(Posted by Tom Lamb at DrugInjuryWatch.com)

Some conflicting and rather disturbing data about the safety of Merck's NuvaRing vaginal ring birth control method emerged in early May 2012 from two different medical studies.

The first study -- for which the costs were reimbursed by Merck, the marketer of NuvaRing -- found no increased risk of venous thromboembolism (VTE) development between the combination contraceptive vaginal ring (NuvaRing) and combined oral contraceptives (COCs, or birth control pills).

The second study -- done by a set of independent researchers, i.e., no support from any organization for the subject study -- had quite a different finding:

With an incidence of 7.8 confirmed events per 10 000 exposure years, the vaginal ring [NuvaRing] conferred a 90% higher risk of venous thrombosis than did combined oral contraceptives containing levonorgestrel, bringing the risk to the same level as that of combined oral contraceptives with third and fourth generation progestogens, and compatible with the Food and Drug Administration study [done by the FDA Office of Surveillance and Epidemiology in 2011, "Combined hormonal contraceptives (CHCs) and the risk of cardiovascular disease endpoints." (PDF)]

Source: "Venous thrombosis in users of non-oral hormonal contraception: follow-up study, Denmark 2001-10", published May 10, 2012 by BMJ (free access).

First we will consider the Merck-funded study or trial, called the Transatlantic Active Surveillance on Cardiovascular Safety of NuvaRing, which was presented May 7, 2012 at the American Congress of Obstetricians and Gynecologists (ACOG) 60th Annual Clinical Meeting. We get this summary of the findings from a May 9, 2012 MedPage article (free registration required), "No Increase in VTE Risk with Vaginal Ring":

A large-scale study found no difference in venous thromboembolism (VTE) development between the combination contraceptive vaginal ring (NuvaRing) and combined oral contraceptives, researchers reported here.

Of the 34 VTEs that occurred in the 66,489 women-years of contraceptive use, the rate of VTE was 8.8 per 10,000 woman-years for the vaginal ring and 9.9 per 10,000 for combined oral contraceptives, a difference that was not statistically significant, according to Klaas Heinemann, MD, PhD, of the Center for Epidemiology and Health Research in Berlin, and colleagues.

Overall, use of hormone contraceptives resulted in a VTE rate of 9.4 per 10,000 woman-years, Heinemann said in his presentation at the annual meeting of the American College of Obstetricians and Gynecologists.

"Venous thromboembolism rates are similar for NuvaRing and combined oral contraceptives," Heinemann said. "A twofold risk of venous thromboembolism for NuvaRing users compared to combined oral contraceptives can be excluded." (emphasis added)

This "twofold risk" may or may not be a vague reference to the 2011 NuvaRing study done by the FDA, which we wrote about in an earlier article, "NuvaRing Update: October 2011 FDA Study Finds Increased Risk Of Pulmonary Embolism (PE) And Deep Vein Thrombosis (DVT)".

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Next, we turn to the BMJ study, which adds to the evidence that women using the NuvaRing face higher thrombosis, or blood clots, risk than those taking oral contraceptives. Some of the findings by Danish researchers Øjvind Lidegaard, Lars Hougaard Nielsen, Charlotte Wessel Skovlund, and Ellen Løkkegaard are set forth in a May 10, 2012 HealthDay News article, "Blood Clot Risk Linked to Some Non-Pill Contraceptives":

For women who did not use any type of hormonal contraceptive, two women developed clots for every 10,000 (combined) years they used contraceptives.

For women taking the pill containing the hormone levonorgestrel, the risk for a clot was three times higher, or 6.2 clots for every 10,000 years they took the pill, the researchers found.

The risk to women who used a skin patch [Ortho Evra] was about eight times higher, or 9.7 clots per 10,000 exposure years.

Women who used a vaginal ring [NuvaRing] had a 6.5 times higher risk, or 7.8 events per 10,000 exposure years.

Of course we will continue to watch for more medical research and trials concerning the safety of Merck's NuvaRing birth control product, especially the possible continuation of the FDA NuvaRing safety study which was done in 2011, as mentioned above.

And, perhaps these conflicting findings about NuvaRing side effects -- like pulmonary embolism (PE) and deep vein thrombosis (DVT), as well as strokes and heart attacks -- will be presented by the FDA to its Reproductive Health Drugs and Drug Safety and Risk Management advisory committees at a joint meeting -- similar to what was done in December 2011 for the controversial YAZ and Yasmin birth control pills.

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1,165 Fosamax - Femur Fracture Lawsuits Pending As Of December 2011 According To Merck Report

2012-05-09T15:51:00-04:00

825 Lawsuits Are Part Of New Jersey State Court Mass Tort Consolidation; Majority Of Other Cases Are Filed In "Second" Fosamax Federal Court MDL

(Posted by Tom Lamb at DrugInjuryWatch.com)

The following information about the number of Fosamax - femur fracture lawsuits that had been filed before January 2012 comes from pages 117-118 of the Merck & Co., Inc. Form 10-K Annual Report For the Fiscal Year Ended December 31, 2011, which was filed with the Securities and Exchange Commission on February 28, 2012:

As previously disclosed, Merck is a defendant in product liability lawsuits in the United States involving Fosamax (the “Fosamax Litigation”). As of December 31, 2011, approximately 2,345 cases, which include approximately 2,800 plaintiff groups, had been filed.... In approximately 1,180 of these actions, plaintiffs allege, among other things, that they have suffered osteonecrosis of the jaw (“ONJ”).... In addition, plaintiffs in approximately 1,165 of these actions generally allege that they sustained femur fractures and/or other bone injuries in association with the use of Fosamax....

As of December 31, 2011, approximately 825 cases alleging femur fractures and/or other bone injuries have been filed in New Jersey state court and are pending before Judge Higbee in Atlantic County Superior Court. The parties have selected an initial group of 30 cases to be reviewed through fact discovery. Plaintiffs subsequently dismissed or advised that they will dismiss seven of the cases that were selected and discovery in the remaining cases is continuing. No trial dates for any of the New Jersey state femur fracture cases have been set.

In October 2008 the New Jersey Supreme Court designated all pending and future Fosamax cases as a "Mass Tort" and assigned them for centralized management in Atlantic County by Judge Carol Higbee. The NJ Fosamax consolidation includes both femur fracture lawsuits and ONJ cases.

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As regards the federal courts, in May 2011 the Judicial Panel on Multidistrict Litigation (JPMDL) granted a petition filed by Merck seeking creation of a Fosamax - femur fractur multidistrict litigation (MDL).

By means of this May 2011 JPMDL order, all pending Fosamax - femur fracture lawsuits filed in the federal court system were transferred to the District of New Jersey and assigned to the Honorable Garrett E. Brown, Jr., for coordinated or consolidated pretrial proceedings. This "second" Fosamax multidistrict litigation (MDL) case is IN RE: FOSAMAX (ALENDRONATE SODIUM) PRODUCTS LIABILITY LITIGATION (NO. II), MDL No. 2243.

Again, from the Merck & Co., Inc. Form 10-K Annual Report For the Fiscal Year Ended December 31, 2011:

... Judge Joel Pisano was assigned to preside over the litigation in November 2011 due to Judge Brown’s retirement. A Case Management Order has been entered that requires the parties to review 40 cases (later reduced to 33 cases) with a fact discovery deadline of July 31, 2012, an expert discovery deadline of November 28, 2012, and a projected trial date for the first case to be tried sometime after March 1, 2013.

The "first" Fosamax federal court MDL case is IN RE: FOSAMAX PRODUCTS LIABILITY LITIGATION, MDL No. 1789 (Southern District of New York), with United States District Court Judge Joseph F. Keenan presiding. That Fosamax MDL, which is limited to osteonecrosis of the jaw (ONJ) and other jaw injury cases, was formed back in 2006 and Fosamax - ONJ trials are continuing there in 2012 while a Special Master conducts settlement discussions.

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The Victoza - Pancreatitis Issue: Some Related Developments From April 2011 To April 2012

2012-05-04T17:02:41-04:00

A Drug Safety Controversy Continues: Whether It Is The Diabetes Drug Or The Diabetes Which Causes Pancreas Disease

(Posted by Tom Lamb at DrugInjuryWatch.com)

As regards the possible association between Victoza and pancreatitis as a side effect of this diabetes drug from Novo Nordisk, there have quite a few assorted developments during the period April 2011 to April 2012. In order to get those all out in front of us, and so as to see how this drug safety issue emerged and where it may be headed going forward, we offer the following time-line of sorts.

April 2010

"Acute Pancreatitis Associated with Liraglutide", The Annals of Pharmacotherapy.

"Medical Journal Withdraws Article About Januvia And Byetta After It Gets Letters From Two Drug Companies", Drug Injury Watch.

According to a news item published April 11, 2011 by The British Medical Journal (BMJ), letters written by Merck and Novo Nordisk to Anil Rustgi, the editor-in-chief of Gastroenterology, resulted in that journal withdrawing an article which it had posted on its website about how Januvia (sitagliptin) and Byetta (exenatide) have been associated with an increased risk of pancreatitis as well as several cancers.

From this April 2011 BMJ piece, "Journal withdraws article after complaints from drug manufacturers"....

P.S. The diabetes drug Januvia is marketed by Merck.

Byetta is marketed by Amylin Pharmaceuticals and Eli Lilly.

Novo Nordisk has a relatively new diabetes drug, Victoza (approved by FDA in 2010), which is in the same class of drugs as Byetta. Victoza (liraglutide) has been linked to pancreatitis, also.

June 2011

"FDA Warns of Serious Risks Associated With [Victoza (Liraglutide)]", Medscape.

Victoza (liraglutide [rDNA origin]) Injection: REMS - Risk of Thyroid C-cell Tumors, Acute Pancreatitis, FDA.

Dear Healthcare Professional Letter, Novo Nordisk.

"Acute Pancreatitis Case Associated With Victoza Use, Similar To Byetta And Januvia Case Reports", Drug Injury Watch.

March 2012

"Liraglutide-associated acute pancreatitis.", American Journal of Health-System Pharmacy.

April 2012

"Public Citizen to FDA: Pull Diabetes Drug Victoza From Market Immediately", Press Release issued by Public Citizen.

Petition to Ban Diabetes Drug Liraglutide (Victoza), Letter to FDA from Public Citizen.

"Novo Nordisk rejects diabetes drug Victoza complaint", Reuters

With Novo Nordisk and Public Citizen engaged in this public battle, now, about a year after the Victoza and pancreatitis link first received some profile, I am sure there is much more to come on all fronts, including the FDA, as we go forward. Of course, we will be watching....

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Bayer Settlements For YAZ / Yasmin Lawsuits Involving Blood Clot Side Effects Like Deep Vein Thrombosis And Pulmonary Embolism

2012-04-30T16:49:49-04:00

While Mediations And Negotiations Continue, The First Scheduled YAZ / Yasmin Trials In Federal And State Courts Are Postponed Indefinitely

(Posted by Tom Lamb at DrugInjuryWatch.com)

In late April 2012 Bayer announced that it has settled lawsuits involving YAZ and Yasmin side effects related to blood clots, namely deep vein thrombosis (DVT) and pulmonary embolism (PE) cases.

From an April 26, 2012 Bloomberg news report, "Bayer Yasmin Lawsuit Settlements Climb to $142 Million":

Bayer, based in Leverkusen, Germany, has resolved 651 cases alleging its Yasmin and Yaz contraceptives caused sometimes-fatal clots that can lead to heart attacks and strokes, the company said today in its Stockholders’ Newsletter for the first quarter. The company said it paid $142 million in the settlements....

“Bayer is only settling claims in the U.S. for venous clot injuries (deep vein thrombosis or pulmonary embolism) after a case specific analysis of medical records,” the company said in the report.

The Yasmin and YAZ lawsuits filed in the federal court system are consolidated before U.S. District Judge David Herndon in the case In re Yasmin and Yaz (Drospirenone) Marketing, Sales Practices and Product Liability Litigation, 09-md-02100, U.S. District Court, Southern District of Illinois (East St. Louis), which is commonly referred to as the Yasmin and YAZ MDL, where the majority of these cases are pending.

There are also state court consolidations for Yasmin and YAZ lawsuits filed in New Jersey and Pennsylvania.

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Judge Herndon as well as the NJ and PA state court judges have postponed indefinitely the so-called "bellwether", or test case, trials that were suppose to begin this year while Bayer attempts to reach settlements with the thousands of women who suffered a DVT and/or PE while using Yasmin or YAZ. If the mediations and negotiations to settle those lawsuits are not successful, it is likely the respective judges will set new starting dates for the first YAZ and Yasmin court trials.

At the present time, the fate of thousands of gallbladder removal cases is uncertain, with Bayer not discussing settlement of those YAZ and Yasmin lawsuits but with gallbladder (GB) trials included on the original set of first bellwether trials scheduled in the federal court MDL proceeding and the Pennsylvania state court consolidation.

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Pradaxa Noted For Possible Heart Attack Risk In Addition To Serious Gastrointestinal Bleeding And Other Hemorrhages

2012-04-24T16:04:00-04:00

Recent Medical Article And Poster Presentation Both Point To A Trend Toward Increased Rate Or Risk Of Myocardial Infarction (MI)

(Posted by Tom Lamb at DrugInjuryWatch.com)

A recent "position paper" by a group of experts from the European Society of Cardiology (ESC) Working Group on Thrombosis provides an update on the side effects associated with Pradaxa (dabigatran). In part, it pointed out there is increasing evidence of heart attacks, or myocardial infarction (MI), in patients using this relatively new anticoagulation drug from Boehringer Ingelheim.

In "New Oral Anticoagulants in Atrial Fibrillation and Acute Coronary Syndromes: ESC Working Group on Thrombosis-Task Force on Anticoagulants in Heart Disease Position Paper", published in April 2012 by the Journal of the American College of Cardiology, these ESC experts noted some specific Pradaxa side effects "such as an increased rate of dyspepsia and gastrointestinal bleeding, [as well as] a trend toward an increased risk of myocardial infarction...."

A second development about the Pradaxa - heart attack connection came out of the March 2012 American College of Cardiology (ACC) meeting in Chicago. In particular, a so-called "poster" presentation, "Dabigatran and Myocardial Infarction, Drug or Class Effect. Meta-analysis of Randomized Trials with Oral Direct Thrombin Inhibitors", provided this information about Pradaxa and heart attacks:

Background: The recent trial on dabigatran versus warfarin in Atrial Fibrillation (RE-LY) demonstrated dabigatran 150 mg twice daily was associated with small but statistically significant increased number of Myocardial Infarction (MI) as compared to warfarin. The purpose of this study was to investigate whether this finding was due to Drug or Class effect.

Methods: We systematically searched MEDLINE using key words, oral, direct thrombin inhibitors and randomized trials. Studies were included in Meta-Analysis if comparison between an oral direct thrombin inhibitor and warfarin was made for any indication and if data on Myocardial Infarction after randomization was available....

Conclusions: 1) Our findings suggest an overall trend toward increased rate of myocardial infarction for patients treated with oral direct thrombin inhibitors and dabigatran in particular as compared to warfarin. This trend is statistically significant and may be suggestive of a class effect based on Fixed effect model Meta-Analysis. 2) Clinicians involved in the care of patients with coronary artery disease may need to exercise caution in the use of these agents. 3) Further research is needed to address these concerns.

The possibility that patients who use Pradaxa have an increased risk for heart attack was first given some profile with a study report published in early January 2012 by the Archives of Internal Medicine.

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The April 2012 ESC "position paper" as well as the March 2012 ACC "poster" presentation, however, seem to indicate that there is growing concern about a Pradaxa heart attack side effect.

To this point in time, and still, most of the scrutiny on Pradaxa from drug safety regulators and others had been about hemorrhages, including gastrointestinal bleeding, as seen from these prior posts:

We will continue to track Adverse Event Reports (AERs) regarding Pradaxa and let you know about significant developments here at Drug Injury Watch.

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April 2012 Fosamax Trial Jury Verdict For Sessner v. Merck Case Expected Soon In New Jersey

2012-04-18T14:23:34-04:00

Closing Arguments Focus On Medical Issue Of Whether Or Not Fosamax Causes Osteonecrosis Of The Jaw (ONJ)

(Posted by Tom Lamb at DrugInjuryWatch.com)

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UPDATE: Defense Verdict For Merck

Ques #1: Did Mrs. Sessner have ONJ? Yes (6-0)

Ques #2: Did Fosamax cause her ONJ? No (5-1)

(4/18/12)

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On April 18, 2012 the jury for the Jo Ann Sessner vs. Merck Fosamax trial, which started back on March 5, was given their "jury charge" by New Jersey state court Judge Carol Higbee, and we expect a jury verdict to be rendered later this week.

The day before, April 17, this jury heard the closing arguments for both sides, which were presented by defense lawyers Christy Jones and Paul Strain on behalf of Merck, and by plaintiff attorneys Tim O'Brien and Gary London on behalf of Mrs. Sessner.

Although the Merck defense lawyers covered lots of ground in their respective arguments, their main points seemed to be:

Osteonecrosis of the jaw (ONJ) is not caused by Fosamax, ever (or, put another way, Merck's corporate position is: Fosamax has never caused a single case of ONJ / no causal relationship has been established between Fosamax and ONJ); and,
In the alternative, even if Fosamax does cause ONJ, it did not cause Mrs. Sessner's "jaw problems"; instead, any ONJ was due to a prior bone infection, i.e., osteomyelitis, which Sessner developed independent of Fosamax (this being the opinion of Merck's medical causation expert).

To emphasize that second point, Ms. Jones used a slide during her presentation to the jury which was titled "The BRONJ Puzzle Does Not Fit For Mrs. Sessner", with BRONJ being short for "bisphosphonate-related osteonecrosis of the jaw".

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Stepping back for a second, before the closing arguments -- from observing the evidence that the jury saw and the witness testimony that they heard (which I was able to do daily from the comforts of my office in North Carolina thanks to Courtroom View Network (CVN), which had cameras that were webcasting the Sessner trial from Judge Higbee's courtroom in New Jersey) it seemed to me that the Sessner verdict might depend on whether the jury "prefers" , i.e., they liked better and/or believed more: The defense medical causation expert witness, Brent Ward, MD, DDS, or Mrs. Sessner's treating doctors, Charles Russo, MD and Robert Marx, MD.

Returning to what the jury heard on April 17, Mrs. Sessner's attorneys reiterated these several contentions, which they had constantly asserted throughout the trial:

Merck never acknowledged that Fosamax has caused ONJ -- not a single case -- despite all the thousands of adverse event reports (AERs) submitted by doctors;
To find for Merck you, i.e., the jury, must disagree not only with Mrs. Sessner's treating doctors but, also, the patient's medical records (or, put otherwise, the evidence versus the defense expert's speculation);
Who do you believe: The defense experts who were brought in after the lawsuit was filed or the treating doctors who diagnosed and treated Mrs. Sessner's ONJ before there was any conception of a Fosamax lawsuit ever being filed; and,
Last but not least, Fosamax did nothing for Jo Ann Sessner, it only did something to her.

Of course, we will be watching for the Sessner trial jury verdict announcement and we will update this article with the "plaintiff verdict" or "defense verdict" result as soon as possible, thereafter.

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Pradaxa Hemorrhage Cases May Occur In Oldest Patients Due To Age-Related Decline In Renal Function

2012-04-16T15:04:00-04:00

QuarterWatch 2011 Quarter 2: More Pradaxa Adverse Events Reported Than Any Other Regularly Monitored Drug

(Posted by Tom Lamb at DrugInjuryWatch.com)

The developing drug safety controversy involving the anticoagulation drug Pradaxa (dabigatran) has been presented best, perhaps, by the ISMP QuarterWatch publication, which served as the basis for these two past articles about the problems with Pradaxa:

(1) New Heart Drug Pradaxa May Be Sending "Early" Drug Safety Signals -- ISMP QuarterWatch 2010 4th Quarter: Hemorrhages And Thromboembolic Events Have Been Reported To FDA

(2) Pradaxa: Excess Number Of Severe Bleeding Events In Certain Patient Populations And Settings -- At Increased Risk Are Patients Who Are Older, Have Altered Renal Clearance, Or Undergoing Atrial Fibrillation (AF) Ablation (citing the ISMP QuarterWatch 2011 Quarter 1 edition)

And the latest Pradaxa safety "update" comes from ISMP QuarterWatch 2011 Quarter 2 (PDF), which was released April 5, 2012:

[(Pradaxa (dabigatran)] a new anticoagulant intended to reduce the risk of stroke, was a suspect drug in 856 reported cases, more than any other regularly monitored drug, but showed a decrease from 931 reports in the previous quarter. The new quarterly total included 117 reported patient deaths. With 511 reported cases of hemorrhage, and a median patient age of 80 years, these new bleeding reports reinforce our concern that vulnerable older patients may be receiving an overdose of this one-size-fits-all drug.

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To provide a typical example of what type of patient is experiencing serious side effects associated with Pradaxa, we turn to "Dabigatran-Induced Gastrointestinal Bleeding in an Elderly Patient with Moderate Renal Impairment", a case report article published online April 10, 2012 by The Annals of Pharmacotherapy. In relevant part, from the Asbtract for this report:

OBJECTIVE: To report a case of dabigatran-induced overanticoagulation in a patient who developed acute renal failure and to inform health care providers of the need for appropriate patient selection and periodic monitoring of renal function in the elderly.

CASE SUMMARY: A 66-year-old woman treated with dabigatran for atrial fibrillation developed acute renal failure and upper gastrointestinal bleeding. She had been taking dabigatran 150 mg twice daily for 2 months, with intermittent renal insufficiency during the previous 6 months.... Her renal function never recovered and she remained hemodialysis-dependent. After a 47-day length of stay, she was transferred to a nursing home where she died 2 months later.

DISCUSSION: Renally eliminated drugs such as dabigatran place elderly patients at increased risk of drug accumulation and adverse drug events due to age-related decline in renal function.... In our patient, the Naranjo probability scale indicated a probable cause between the bleeding event and dabigatran use.

Our thanks to the ISMP QuarterWatch publication for staying on top of this Pradaxa safety story, which we will continue to follow and report on, here.

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April 2012 Yasmin / YAZ Label Change: FDA Warns About Increased Risk Of Blood Clots Possible Due To Drospirenone

2012-04-10T16:15:27-04:00

Beyaz, Safyral, Ocella, Gianvi, Zarah, Loryna, Syeda, And Vestura OC Pills Contain DRSP Progestin Also

(Posted by Tom Lamb at DrugInjuryWatch.com)

On April 10, 2012 the FDA issued "Drug Information Update - Drug Safety Communication: Updated information about the risk of blood clots in women taking birth control pills containing drospirenone", an email alert which initially let us know about a significant revision to the package insert, or drug label, for the following oral contraceptive (OC) pills:

YAZ, Yasmin, Beyaz, and Safyral, which are manufactured by Bayer HealthCare Pharmaceuticals, Inc.;
Ocella, a generic version of Yasmin, and Gianvi, a generic version of YAZ. The Ocella and Gianvi birth control pills are from Teva Pharmaceuticals and Barr Laboratories;
Zarah, a generic version of Yasmin, and Vestura, a generic version of YAZ. The Zarah and Vestura oral contraceptives are made by Watson Pharmaceuticals; and
Loryna, a generic version of YAZ, and Syeda, a generic version of Yasmin. The Loryna and Syeda OCs are made and sold by Sandoz, Inc.

In summary, the FDA has completed its review of some relatively recent medical studies regarding these drospirenone-containing oral contraceptives which was intended to determine whether there was any increased risk of blood clots in women using one of these DRSP OCs. Based on this review, FDA has concluded that Yasmin, YAZ, Safyral, and Beyaz, as well as the other generic birth control pills containing drospirenone (DRSP), may be associated with a higher risk for blood clots than those pills with other progestins, such as levonorgestrel.

As a result of this determination, the labels for Yasmin, YAZ, Safyral, and Beyaz were revised by Bayer and the FDA in April 2012 by adding information about the various medical studies concerning the increased blood clot risks associated with drospirenone-containing birth control pills.

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In turn, the drug labels for the generic DRSP birth control pills -- Ocella, Gianvi, Zarah, Loryna, Syeda, and Vestura -- will be revised by their respective responsible drug companies in the near future, as they are required to do by law.

For more details about this April 2012 drospirenone (DRSP) label revision announcement by the FDA, see: "FDA Drug Safety Communication: Updated information about the risk of blood clots in women taking birth control pills containing drospirenone".

In addition, this list of background articles about certain developments leading up to the April 2012 Yasmin / YAZ / Safyral / Beyaz label change may be of interest to those wanting to know more about this rather significant drug labelling revision:

Yasmin / Safyral / Beyaz: February 2012 Label Change Non-Specific To These Bayer Birth Control Pills

YAZ / Yasmin January 2012 Update: Minutes And Transcripts For FDA Advisory Committees 2011 Meeting Now Available Online (And More)

YAZ / Yasmin: December 2011 FDA Advisory Committees Meeting Background Materials Now Available Online

Two More Medical Studies Show Increased Risk Of Blood Clots With Use Of YAZ, Yasmin, And Ocella

YAZ / Yasmin / Ocella Update: October 2011 FDA Study Finds Increased Risk Of Blood Clot Side Effects Like DVT, PE, Stroke, And Heart Attack

YAZ / Yasmin / Ocella: FDA Study Suggests An Increased Risk Of Blood Clots That Can Cause Side Effects Like Pulmonary Embolism

Another Rather "Odd" YAZ Label Change By Bayer: March 2011

Is Bayer Warning Or Attacking With Its New YAZ / Yasmin Package Insert, Or Label, In The U.S

March 2010: Bayer Says It Will Update Yasmin Label In Europe To Add Results From Four Medical Studies

Of course, we will continue to monitor both the drug safety and the legal / litigation aspects of this particular set of birth control pills containing drospirenone (DRSP).

P.S. April 2012 YAZ Prescribing Information (PDF) Recent Major Changes: Warnings and Precautions, Thromboembolic Disorders (5.1) 4/2012
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Current Use Of Cipro And Levaquin Associated With Increased Risk Of Detached Retina Eye Injury

2012-04-04T17:10:00-04:00

Neither Recent Nor Past Use Of These Antibiotics In Fluoroquinolones Class Was Related To Retinal Detachment

(Posted by Tom Lamb at DrugInjuryWatch.com)

Patients taking oral antibiotics known as fluoroquinolones such as Cipro (ciprofloxacin) and Levaquin (levofloxacin) are at an increased risk for developing a detached retina, an eye injury which can lead to permanent blindness if not medically treated in a timely manner.

This new drug safety finding comes from a case-control study, "Oral Fluoroquinolones and the Risk of Retinal Detachment", which was published in the April 4, 2012 edition of the Journal of the American Medical Association (JAMA).

From the Abstract for this April 2012 JAMA article concerning Levaquin, Cipro, and similar antibiotics possibly causing damage to one's eyes:

Context Fluoroquinolones are commonly prescribed classes of antibiotics. Despite numerous case reports of ocular toxicity, a pharmacoepidemiological study of their ocular safety, particularly retinal detachment, has not been performed.

Objective To examine the association between use of oral fluoroquinolones and the risk of developing a retinal detachment....

Results From a cohort of 989 591 patients, 4384 cases of retinal detachment and 43 840 controls were identified. Current use of fluoroquinolones was associated with a higher risk of developing a retinal detachment (3.3% of cases vs 0.6% of controls; adjusted rate ratio [ARR], 4.50 [95% CI, 3.56-5.70])....

Conclusion Patients taking oral fluoroquinolones were at a higher risk of developing a retinal detachment compared with nonusers, although the absolute risk for this condition was small.

For some insight about the underlying medical study and its significance from one of the researchers, Mahyar Etminan, PharmD -- who is from the Therapeutic Evaluation Unit, Child and Family Research Institute of British Columbia, and the Department of Medicine, University of British Columbia, Vancouver, Canada -- we move to this Reuters news report, "Common antibiotics tied to eye emergencies: study", published on April 3, 2012:

People treated by ophthalmologists for the emergency condition were five times more likely to be taking drugs known as fluoroquinolones, which include ciprofloxacin (marketed under names including Zoxan, Proquin and Cipro) and levofloxacin (Levaquin, Cravit), than those who didn't have retinal detachment.

"We know that these drugs are toxic to connective tissue and cartilage," said Mahyar Etminan, the study's lead author, noting past studies linking fluoroquinolones with damage to Achilles and shoulder tendons.

"We wanted to see whether this damage also may translate in the eye, because there's lots of connective tissue in the eye," Etminan, from the Child and Family Research Institute of British Columbia in Vancouver, told Reuters Health.

Retinal detachment, which starts as the appearance of lines, dots or "floaters" across the eye, can cause permanent blindness in some cases if it's not surgically treated within a few days....

Retinal detachment is rare, Etminan concluded, "but because the condition is quite serious, I don't think it would hurt to let someone know... if you notice these flashes of light or floaters, be sure you get it checked out."

Of course, we will continue to monitor this emerging drug safety issue involving Levaquin, Cipro, and other antibiotics in the fluoroquinolones class of drugs.

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