December Yaz Litigation News: Bayer Withheld Yasmin Data From U.S., Former Agency Chief Tells Court

From Bloomberg:

A Bayer AG unit withheld from U.S. regulators findings by company researchers of increased reports of blood clots in users of its Yasmin birth-control pills, the former head of the Food and Drug Administration said.

David Kessler, the former FDA commissioner, in a document unsealed yesterday in federal court in Illinois, said Bayer didn’t include an analysis “that demonstrated an increase in the U.S. reporting rate” for venous thromboembolism, or clots, in a 2004 review of Yasmin’s safety provided to the agency.

The report also didn’t include an earlier draft opinion by company researchers that “spontaneous reporting data do signal a difference in the VTE rates for Yasmin” compared with other oral contraceptives, Kessler said, quoting the draft.

“Bayer presented a selective view of the data, and that presentation obscured the potential risks associated with Yasmin,” Kessler said.

Kessler’s report and four other expert opinions were released yesterday by lawyers representing former users of Bayer’s Yasmin family of contraceptives. The experts were paid by the plaintiffs’ lawyers, who submitted the reports to the FDA, which is considering safety findings on Yasmin and its sister product Yaz at a hearing Dec. 8.

http://www.bloomberg.com/news/2011-12-05/bayer-withheld-yasmin-clot-risk-data-from-u-s-ex-agency-head-tells-court.html

Will the FDA Ask That Yaz Be Removed from the Market?

There are preliminary results that a FDA-funded study of Yaz and similar drospirenone-based contraceptives show they carry a 1.5-fold increase in the risk of  blood clots compared to older hormonal contraceptives. That study follows six others, four of which have shown an increased clot risk for Yaz and its ilk.
 
The DrugCite database of adverse event information culled from the FDA shows that blood-clot events are more common for pills containing drosperinone than for levonorgestrel, an older version of the progestin ingredient in contraceptive pills:

• Most Common Drospirenone Adverse Events
  
• Pulmonary Embolism: 119
• Deep Vein Thrombosis: 99
• Gallbladder Injury: 57
• Thrombosis: 20
• Most Common Levonorgestrel Adverse Events
• Pulmonary Embolism: 17
• Deep Vein Thrombosis: 10
• Thrombosis: 9
• Gallbladder Injury: 0

Source here

Yaz Recall? Yes there was one

Image via CrunchBase

Good work by Jim Edwards:

The FDA did issue a recall for Yaz back in November 2009. The reason: Bayer had reported the product was “within specification” when in fact it wasn’t — the company had taken a number of measures and averaged them together to get the number it needed.

It involved specifications for the dosage of drospirenone in the pill, which is the new ingredient that the lawsuits allege is more dangerous than the traditional recipe.


From the FDA site:

PRODUCT
1) YAZ (Drospirenone & Ethinyl Estradiol); Rx only; 3.0 mg drospirenone &0.02 mg ethinyl estradiol; 3 x 28 tablets- blister packages 24 active and 4 placebo, NDC 50419-405-03. Recall # D-046-2010;

2) Ocella (drospirenone and ethinyl estradiol tablets) 3 mg/0.3 mg, Rx only;This package contains one blister of 28 tablets: 21 yellow tablets, containing 3 mg of drospirenone and 0.3 mg of ethinyl estradiol; and seven white inert tablets', NDC 0555-9131-767. Recall # D-047-2010
CODE
1) Lot 91605A, Exp 12/2013;
2) Lot number 84080A, Exp 12/2011; lot number 84081A, Exp. 12.2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bayer HealthCare Pharmaceuticals, Inc., Wayne, NJ, by letters on November 6, 2009.
Manufacturer: Schering Gmbh Und Co. Produktio, Weimar, Germany. Firm initiated recall is ongoing.
REASON
CGMP Deviations:Out of Specification analytical value for chemical assays of drospirenone and ethinyl estradiol was averaged with another analytical value to provide a reported result that was within specification.
VOLUME OF PRODUCT IN COMMERCE
1) 32,856 boxes (3 blister packages/box);
2) 122,208 boxes (3 blister packages/box)

Source: http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm192035.htm

Study: Yasmine may cause increase in blood clots (Georgia/Florida)

An independent study was conducted by researchers at the Leiden University Medical Center in the Netherlands. The results were published in the British Medical Journal during the summer of 2009.

The Leiden University study concluded that birth control pills containing the ingredient drospirenone – like Yasmin – are two times more likely to cause blood clots than other birth control pills, which generally contain levonorgestrel. The alleged increased risk of blood clots from Yasmin side effects was not offset by effectiveness. Researchers discovered that all of the oral contraceptives involved in the study were equally effective in preventing pregnancy.

From the abstract:
Participants Premenopausal women <50 years old who were not pregnant, not within four weeks postpartum, and not using a hormone excreting intrauterine device or depot contraceptive. Analysis included 1524 patients and 1760 controls.

Main outcome measures First objectively diagnosed episodes of deep venous thrombosis of the leg or pulmonary embolism. Odds ratios calculated by cross-tabulation with a 95% confidence interval according to Woolf’s method; adjusted odds ratios estimated by unconditional logistic regression, standard errors derived from the model.

Results Currently available oral contraceptives increased the risk of venous thrombosis fivefold compared with non-use (odds ratio 5.0, 95% CI 4.2 to 5.8). The risk clearly differed by type of progestogen and dose of oestrogen. The use of oral contraceptives containing levonorgestrel was associated with an almost fourfold increased risk of venous thrombosis (odds ratio 3.6, 2.9 to 4.6) relative to non-users, whereas the risk of venous thrombosis compared with non-use was increased 5.6-fold for gestodene (5.6, 3.7 to 8.4), 7.3-fold for desogestrel (7.3, 5.3 to 10.0), 6.8-fold for cyproterone acetate (6.8, 4.7 to 10.0), and 6.3-fold for drospirenone (6.3, 2.9 to 13.7). The risk of venous thrombosis was positively associated with oestrogen dose. We confirmed a high risk of venous thrombosis during the first months of oral contraceptive use irrespective of the type of oral contraceptives.

Conclusions Currently available oral contraceptives still have a major impact on thrombosis occurrence and many women do not use the safest brands with regard to risk of venous thrombosis.

http://www.bmj.com/cgi/content/abstract/339/aug13_2/b2921

Georgia: Yaz and Yasmine Injury Lawsuits

New Jersey state courts have designed claims relating to Yaz as a mass tort, and will be centralized under one judge for coordinated handling.

New Jersey’s Administrative Office of the Courts ordered on February 18 that the litigation will be assigned to Judge Brian R. Martinotti in Bergen County Superior Court. All pending and future New Jersey state court Yaz lawsuits, Yasmin lawsuits and Ocella lawsuits filed over Bayer’s popular birth control pills will be handled by Judge Martinotti, who will oversee the case management and trial issues.

Bayer Healthcare Corp. stated its oral contraceptives Yasmin and Yaz contained possible side effects, the pills' maker said in response to lawsuits.

More than 50 women in Indianapolis have filed suit against the company, joining dozens of women nationwide who allege the birth control pills caused heart attacks, strokes, blood clots and other health problems, The Indianapolis Star reported Monday.

Yasmin and Yaz contain drospirenone, which the lawsuits allege can lead to dangerously high levels of potassium.

Bayer officials said the contraceptives are safe when used properly and that all packages of oral contraceptives, including Yasmin and Yaz, carry warnings of possible side effects.

UPI is the source.

Yaz & Yasmin Injury, Georgia

Our office is investigating claims of injury related to the birth control pills known as Yaz or Yasmin:

Yasmin and Yaz are two types of birth control pills manufactured by Bayer Healthcare, and the generic, Ocella, is marketed and distributed by Barr Laboratories, Inc. Yasmin and Yaz contain the same estrogenic compound, ethinyl estradiol, that has been used in “The Pill” since the 1970s, but the progestin in Yasmin and Yaz is new. Yasmin and Yaz both contain drospirenone, a “fourth generation” progestin – no other birth control pills contain drospirenone, except for a recently approved generic version, Ocella.




Side Effects of Yaz/Yasmin Birth Control Pills

Yaz/Yasmin was approved by the Food and Drug Administration (FDA) in 2006 as an oral contraceptive, and was marketed by its manufacturer, Bayer. Once the drug hit the market, however, the FDA started to receive reports of side effects when taking Yaz/Yasmin, including:

* Deep Vein Thrombosis (DVT): Deep vein thrombosis commonly affects the leg veins (such as the femoral vein or the popliteal vein) or the deep veins of the pelvis. Occasionally the veins of the arm are affected (if spontaneous, this is known as Paget-Schrötter disease). The most serious complication of a DVT is that the clot could dislodge and travel to the lungs, which is called a pulmonary embolism (PE). DVT is a medical emergency, present in the lower extremity there is 3% chance of a PE killing the patient.

* Pulmonary Embolism (PE): Pulmonary embolism (PE) is a blockage of the main artery of the lung or one of its branches by a substance that has travelled from elsewhere in the body through the bloodstream (embolism). Usually this is due to embolism of a thrombus (blood clot) from the deep veins in the legs, a process termed venous thromboembolism. A small proportion is due to the embolization of air, fat or amniotic fluid.

* Heart Arrhythmia: An irregular heartbeat is an arrhythmia (also called dysrhythmia). Heart rates can also be irregular. A normal heart rate is 50 to 100 beats per minute. Arrhythmias and abnormal heart rates don't necessarily occur together. Arrhythmias can occur with a normal heart rate, or with heart rates that are slow (called bradyarrhythmias -- less than 60 beats per minute). arrhythmias can also occur with rapid heart rates (called tachyarrhythmias -- faster than 100 beats per minute). In the United States more than 850,000 people are hospitalized for an arrhythmia each year. There are types of this condition:

Premature atrial contractions; Premature ventricular contractions (PVCs); Atrial fibrillation; and Atrial flutter, among others.

* Heart Attack/Myocardial Infarctions and
* Stroke and Transient Ischemic Attacks

What is in the pill:

Yaz/Yasmin contains a synthetic progestin called drospirenone, which some claim will raise blood potassium levels. Doing so may result in a dangerous condition known as hyperkalemia. Hyperkalemia can lead to life-threatening heart problems.