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Yaz contraceptive pill from Bayer faces probe by Swissmedic following death of a woman

Tuesday, September 29, 2009, 12:36 This news item was posted in Consumer, health category and has 0 Comments so far.

The 16-year old woman had been taking Yaz contraceptive for ten months had a “sudden” death.

Yaz, the contraceptive pill from Bayer has been under investigation by Swiss medical authority Swissmedic said for a possible link between the death of a woman from a blood clot 10 months after she was prescribed the drug.

Yasmin, Yaz, and Yasminelle contraceptives from Bayer were its best selling pharmaceutical products last year, generating sales of 1.2 billion euros, according to IMS Health Inc. market research company.

Yaz, which is a the lower-dose version of Bayer’s contraceptive Yasmin, has been proved along with
all birth control pills after a 16-year-old was dead by a lung embolism in May after taking the pill.

The woman had been taking Yaz contraceptive for ten months had a “sudden” death, Swissmedic said on its Web site.

Lung embolism complications are known yet rare side-effects of hormone-based contraceptives and the risk is also increased during pregnancy, Swissmedic.

Yaz contains the progesterone ingredient drospirenone which is found to be riskier than those in other contraceptives, studies suggest.

A study 1,524 patients on Yaz and 1,760 who weren’t found that venous thrombosis — dangerous blood clots — increased fivefold compared to those not using the pill.

Yaz causes a greater-then-usual number of blood clots compared to older pills because of its new progesterone ingredient.

Drospirenone increases the risk for venus thrombosis 6.3-fold compared to levonorgestrel, the safest progesterone which is found in Teva’s Seasonique, according to another comparative study.

Drospirenone is used by no other contraceptive. This forth generation synthetic progestin ingredient can cause a rise in blood potassium levels, causing hyperkalemia.

Hyperkalemia disrupts the normal heart rhythms, the flow of blood through the heart can be slowed to the point that it permits blood clots to form.

Yaz and Yasmin have a higher rate of blood clots than older, safer pills, alleged a law suit by Janet G. Abaray and others in US.

With such a large number of women using oral contraceptives, even the smallest increase of side effects will affect many. Knowledge of these risks and efforts to reduce them are of crucial importance, the alw suit argued.

Safest option with regard to the risk of venous thrombosis is an oral contraceptive containing levonorgestrel combined with a low dose of oestrogen.

In less than a five-year period, from the first quarter of 2004 through the third quarter of 2008, over 50 reports of death among users of Yasmin and Yaz have been filed with the US FDA, reports said.

Yaz received FDA approval in 2006, Yasmin in 2001.

Bayer also ran an unusual $20 million corrective advertising campaign after it found false or misleading claims for Yaz in earlier TV ads.

Yaz was launched launched last year in Europe, by Bayer two years after it began selling it in the United States. Bayer expects the drug to generate peak annual European sales in the low triple-digit millions of euros within five years.

Bayer HealthCare, a subsidiary of Bayer AG, is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals operation of Bayer HealthCare, an affiliate of Bayer AG. One of the world’s leading, innovative companies in the healthcare and medical products industry, Bayer HealthCare combines the global activities of the Animal Health, Consumer Care, Diabetes Care, and Pharmaceuticals divisions. In the United States, Bayer HealthCare Pharmaceuticals comprises the following business units: Women’s Healthcare, Diagnostic Imaging, General Medicine, Hematology/Neurology, and Oncology.

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