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Birth control drugs Yasmin, Yaz and Ocella associated with serious side effects including death

September 30, 2009 Drug Injuries, Products Liability

Yasmin and YAZ are two varieties of combination type birth control pills (BCP) produced by Bayer Healthcare. Yasmin was approved for sale in the US by the FDA in 2001 while YAZ was approved in 2006. Both YAZ and Yasmin contain 3 mg of drospirenone, a progestin, which is combined with 30 mcg of ethinyl estradiol in Yasmin and 20 mcg of this estrogen in YAZ. The estrogen component of these BCPs has been in common use since the 1970s. Drospirenone is a relatively new fourth generation progestin which has been shown to have an anti mineralocorticoid effect. This effect leads to diuresis, (increased urination) while retaining potassium which can lead to elevated serum potassium levels (hyperkalemia). It is suspected that this progestin is the cause of a notable increase in certain adverse effects which include death, arrhythmias, venous and arterial blood clots, gallbladder disease, pancreatitis, liver or kidney failure, dehydration and hypertension. The serious cardiovascular side effect are markedly increased in those who smoke and with advancing age particularly beyond age 35.

yazThe FDA sent a warning letter to Bayer in August 2008 demanding a campaign to correct misleading direct to consumer marketing which had been promoting the use of YAZ for conditions other than those for which it had obtained FDA approval. YAZ had been approved for birth control, for women who suffered from premenstrual dysphoric disorder PMDD (a markedly depressed mood, anxiety or tension affective lability and persistent anger or irritability) and for the treatment of moderate acne vulgaris in women who also desire pregnancy prevention. The advertising in question seemed to give the message that YAZ was indicated for PMS ( a much milder constellation of symptoms than PMDD) and all severities of acne rather than the specific approved indications. The FDA also sent a warning letter to correct misleading advertising to Berlex labs, the original producer of Yasmin in 2003. Bayer acquired the rights to market Yasmin in 2006. In February of 2009 Bayer settled with the FDA and the attorneys general of 27 states to mount a $20,000,000 campaign to correct the misconceptions it had created. The corrective ads ran from February through late July 0f 2009. During the period of ads labeled misleading by the FDA, YAZ sales nearly tripled from the 262 million in 2007 sales.

Ocella is a generic BCP produced by Barr, a maker of many generic drugs, which was approved for sale in 2008 has the same chemical compositions as Yasmin. Likewise, it is believed to have the same side effect profile.

Between 2004 and late 2008 over 50 deaths have been reported to the FDA in users of YAZ or Yasmin. These deaths have usually been due to arrhythmia, intracardiac clots, pulmonary embolism (venous blood clots passing through the heart and into the lungs), and stroke. The have been reported in women under the age of 50 and as young as 17. Many of these fatalities have been noted to have elevated blood potassium which may be the cause for some of the fatal cardiac rhythm disturbances.

YAZ is the best selling BCP in the US with an 18% market share and sales of 616 million dollars in 2008. Yasmin has sales of 382 million in 2008 accounting for an 11% market share. These two drugs alone account for nearly a third of all BCPs sold in the US.

The drug injury attorneys at Wilson Kehoe & Winingham are preparing to accept clients who have been seriously injured from the use of these drugs. Our firm had great success representing persons who had been seriously injured by the use of two recalled drugs, Baycol and Vioxx in the past few years and we anticipate we will discover a number of persons who were seriously injured from the use of YAZ, Yasmin or Ocella.

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