Wednesday, March 30, 2011

Will There Be A Yaz Recall?

Many are wondering if the FDA is ever going to decide to order a complete Yaz recall. It hasn’t happened yet and it may never happen. But considering the history of the drug and the allegations made against both the drug and its manufacturers it is very possible that there is a Yaz recall in the near future.
Thousands of women have found themselves the victim of Yaz and Yasmin side effects. Some of the most common (and serious) Yaz and Yasmin side effects include: gallbladder disease, stroke and pulmonary embolism. During a 4 year time span (from 2004 to 2008) there were 50 reports of Yaz and Yasmin linked deaths reported to the FDA.

Yaz, Yasmin side effects: What Causes Them?

Yaz and Yasmin are both oral contraceptives. They contain a relatively new synthetic progestin called drospirenone. Experts speculate that drospirenone may cause potassium fluctuations. Potassium fluctuations can slow the heart rate. A decrease in the speed of the heart rate can result in an increased likelihood of blood clot formation.
A lethal Yaz pulmonary embolism can also occur. This occurs after a blood clot forms and it then travels through the bloodstream and ends up blocking the main artery of the lung.
The British Medical Journal published a study in 2009 that confirmed the dangers posed by Yaz and Yasmin. The study clearly showed that there was a 6.3-fold increase in blood clot incidence among women on drospirenone containing pills like Yaz and Yasmin.
Another major Yaz or Yasmin side effect is gallbladder disease. There are more than 6,000 US lawsuits currently filed against Bayer. Gallbladder claims make up more than 40% of the 6,000.

Increasing Reports of Adverse Reaction Has Not Resulted in Yaz Recall

There is no evidence that Yaz or Yasmin is more effective than other forms of birth control. At the same time there is evidence that Yaz or Yasmin is more dangerous than other forms of birth control due to the side effects. In spite of this, the FDA has no yet issued a Yasmin or Yaz recall.
A recall is ordered by the FDA when new discoveries are made or new information is revealed that indicates that a drug that is currently approved for use actually has a risk-benefit profile leaving the risk outweighing the benefits available through proper use of the drug. Weighing the risks against the benefits is nowhere near an exact science; it is merely opinion based on fact and circumstance. Therefore it cannot be determined if and when the FDA will issue a Yasmin or Yaz recall. There is not set numerical point at which the recall will automatically ensue.
Darvocet (a popular painkiller) was recalled by the FDA in 2010. It had been on the market and used regularly as a common pain killer for over 50 years. New testing and analysis on Darvocet led the conclusions that the drug could potentially cause cardiac arrhythmia even when it was taken correctly as prescribed.
Past experiences like the Darvocet recall indicate that future studies on Yaz and Yasmin will be vital in creating the impetus needed to bring the risk-benefit profile to light clearly in order to result in a recall. Yaz and Yasmin have been on the market for less than a decade.
Many hope that new research will come to light regarding Yaz and Yasmin that will lead the FDA to call for a recall on the oral contraceptive that so obviously has causal connections to both gallbladder disease and blood clots.

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