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FDA Urges Bayer to Add Warnings on Yaz Label

The United States’ Food and Drug Administration’s advisory panel announced in December 2011 that they had come to the conclusion that warning labels on the popular birth control medication Yaz were not sufficient enough to adequately inform patients of the risks associated with the medication. Yaz has come under fire recently as it has been linked to a number of serious, even life-threatening side effects, such as Yaz blood clots, Yaz stroke, and Yaz deep vein thrombosis (Yaz DVT).

The advisory panel for the FDA voted 21-5 in a vote that took place on December 8, 2011 that manufacturer Bayer should provide the public with more information on the drug’s warning label about serious Yaz side effects, including Yaz blood clots, which can lead to Yaz pulmonary embolism.

Yaz blood clots a growing problem

Yaz blood clots are a potentially serious complication associated with the birth control medication, which is based on a synthetic hormone known as drospirenone. Yaz blood clots can lead to other, more serious conditions, including Yaz deep vein thrombosis, stroke, heart attack, and Yaz pulmonary embolism, which can be fatal in some cases.

More than 10,000 patients have elected to seek assistance from a Yaz lawyer and get involved with Yaz lawsuit filings, which could be helped by the FDA’s recent assessment that Bayer’s side effects warnings were simply not thorough enough.

Yaz was first approved in 2006, and within two years it became one of the most popular birth control pills in the country. By 2011, however, safety warnings and reports of Yaz side effects resulted in an 80 percent drop in sales of the fourth generation birth control pill. The public has become more and more aware of Yaz side effects, despite the fact that the Food and Drug Administration did not get involved until December of 2011.

Although all hormonal birth control methods can increase a woman’s chance of developing blood clots that can lead to more serious complications such as stroke, many studies have shown that Yaz presents a much higher risk of these side effects. An FDA analysis showed that 10 in 10,000 women taking the medication would develop Yaz blood clots, compared to 6 in 10,000 women taking other forms of hormonal contraceptives.

FDA orders more thorough Yaz side effects warnings

The FDA committee acknowledged that some of the studies they used in their decision — one which showed that taking Yaz and Yasmin increased the risk of blood clots by 75 percent, and another that showed twice the risk of blood clots than with other forms of birth control — did not take into account a woman’s medical history or lifestyle factors.

However, they also state that it was clear that Yaz presents a risk of blood clot that is higher than the risk associated with other, similar medications. They maintain that warnings on Yaz packaging are incomplete and that Bayer should amend the information to more accurately reflect the risk associated with Yaz and Yasmin.

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