June 19th, 2011

Bayer Off-Label Promotion Of Yasmin Birth Control Pill For Acne Caused Teenager’s Death: Lawsuit

Pharmalot

The thousands of lawsuits filed against Bayer over alleged injuries and deaths relating to the Yaz and Yasmin contraceptives typically dwell on higher risks beyond those of traditional birth control pills and overly aggressively promotion that failed to disclose the possibility of blood clots, in particular. Now, though, a lawsuit charges off-label promotion for acne caused the death of a 15-year-old girl.

Here’s the back story… In 2007, Brittany Prewitt began to develope the skin condition and was prescribed Yasmin, which was never approved for acne, but had allegedly been promoted, nonetheless, to dermatologists. She was not sexually active and the pill was not prescribed, in her case, for contraception, according to her lawsuit, which was filed in a North Carolina state court.

A closely related Bayer pill called Yaz does have one indication for acne, but it is limited: the product labeling on Yaz states that the pill should be prescribed to “treat moderate acne for women at least 14 years old only if the patient desires an oral contraceptive for birth control.” Both drugs contain drospirenone, and her patient records referred to Yasmin and Yaz simultaneously.

By May 2009, she had been regularly prescribed Yasmin and, later, a generic called Ocella, which was sold by Barr - now owned by Teva Pharmaceuticals - and supplied by Bayer as part of a 2008 licensing agreement. But that spring, the 199-pound teenager developed a swollen left knee and thigh pain. She was allegedly misdiagnosed and, on June 13, 2009, collapsed. She died of bilateral pulmonary emboli.

The lawsuit, which also names her physician and Teva, charges she should never been prescribed the pill, since neither drug was approved by the FDA as a first-line treatment for acne. Her family also maintains Bayer failed to properly and thoroughly warn about the risks of blood clots, while promoting the meds to dermatologists and running a consumer ad campaign that drew warnings from the FDA (see this). You can read the lawsuit here.

The Prewitt death is only the latest struggle for Bayer which has, nonetheless, successfully avoided strict FDA action amid growing controversy. Last month, you may recall, the agency decided to review results of two studies that found women birth control pills containing drospirenone are more likely to develop blood clots than those who take an older oral contraceptive (read here). Reports of blood clots began surfacing in 2003 (see this).

Meanwhile, some 6,000 lawsuits are pending in the US over alleged injuries and deaths relating to Yaz and Yasmin, as well as generics. Two months ago, a Swiss appeals court ruled that a series of television shows about the possible side effects attributed to its pills were not inaccurate and, therefore, legal intervention was not warranted after Bayer filed a complaint (see this). And the Society of Obstetricians and Gynaecologists of Canada published guidelines suggesting there were no increased with the Bayer pills, but failed to disclose the author was a Bayer consultant (look here).

Bayer and the other defendants named in the lawsuit “knew or should have known that Yasmin and Orcella do not conform to…representations (made to physicians and consumers) because the products are not safe and have numerous serious side effects that were substantially more prevalent than with other oral contraceptives used in the treatment of acne, and thus are unreasonably safe for intended purpose,” the lawsuit states. “As a forseeable, direct and proximate result of the breach of these warranties, Brittany Prewitt was injured and died.”

We have asked Bayer for a reply and will update you accordingly.

Read more: http://www.pharmalot.com/2011/06/bayer-off-label-promotion-of-yasmin-birth-control-pill-killed-our-daughter-lawsuit/

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