Drug Injury Watch

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

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)

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July 2012 Litigation Update: Almost 2000 Bayer Settlements For Gianvi / Ocella / Yasmin / YAZ Lawsuits Involving Blood-Clot Side Effects Like Deep Vein Thrombosis (DVT) And Pulmonary Embolism (PE)______________________________________________________________________________

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

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:

• Pradaxa: FDA Investigating Possible Higher Than Expected Incident Rate Of Serious Bleeding Side Effects
• Pradaxa: 2012 Label Revisions In The U.S. And Canada, Where A "Dear Doctor" Letter Was Sent Out

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

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

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

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

(Posted by Tom Lamb at DrugInjuryWatch.com)

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UPDATE:  Bayer's "Dear Doctor" Letter about April 2012 label change (PDF) for its drospirenone (DRSP) birth control pills -- YAZ, Yasmin, Beyaz, and Safyral -- resulting from the December 8, 2011 FDA Advisory Committees meeting.

(6/4/12)

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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

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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