FDA Panel Wants Warning Label Spelling Out Yaz Blood-Clot Risks
A Food and Drug Administration (FDA) panel of experts ruled that the labeling of the popular birth-control pill Yaz should be updated to reflect recent data showing the drug poses a much higher risk of causing blood clots than older contraceptives.
Adelphi, Md. -- A Food and Drug Administration (FDA) panel of experts ruled that the labeling of the popular birth-control pill Yaz should be updated to reflect recent data showing the drug poses a much higher risk of causing blood clots than older contraceptives.
This is not good news for the pharmaceutical giant Bayer AG, maker of the contraceptive s Yaz and Yasmin. Already 10,458 lawsuits have been filed in federal court against Bayer by plaintiffs claiming they werenít warned of the drugís harmful side effects, according to the Southern District of Illinoisís U.S. District Court.
The panel on Oct. 8, 2011 voted 21 to 5 that the current labeling of Yaz and other popular birth-control pills using the manmade hormone progesterone is inadequate in warning users of its potentially deadly side effects.
"Adverse events have to be made graphic so physicians and patients are aware of the consequences,Ē said Dr. Richard Bockman of New Yorkís Hospital for Special Surgery, during the more than nine-hour meeting.
During the early part of the marathon meeting, panel members heard testimony from patients and their family members who say Yaz or Yasmin lead to deadly blood clots.
One of those individuals was a mother who talked about the last conversation she had with her daughter, who died on Christmas Eve of 2008 because of a blood clot that traveled to her lung.
She assured the panel of experts that if her daughter had been aware of the Yasminís risks, she would have opted to take a safer birth-control pill.
Recent Research Triggers Concerns
Itís not surprising that the FDA panel ruled the way it did in light of Yazís long troubled history.
In October of 2011, the FDA issued a statement warning the general public that women taking Yaz or any contraceptive with drospirenone were 74 percent more likely to develop potentially fatal blood clots than those who didnít use such contraceptives.
The FDA made this pronouncement based on overwhelming evidence.
The agency issued the warning only after carefully reviewing research gathered from data on 835,826 women who took the contraceptive including Yaz and Yasmin, which is also made by Bayer.
Based on its past actions, there is little doubt that Bayer will continue to use every financial and legal resource it at its disposal to fight the growing number of lawsuits that are being filed against it as a result of its top-selling contraceptive Yaz and Yasmin.
The FDAís latest action will only add fuel to the fire.Thatís why itís important if you or a loved one has developed a Yaz-related blood clot as a result of taking the drug, you should be aware of all the latest developments surrounding the birth-control pill.
You can easily do this by visiting Yaz Lawsuit, which is a Web site created specifically to inform potential and current victims of Yaz-related blood clots about their rights, as well as their legal options.
All lawsuits are subject to the statute of limitations. Thatís why it makes sense for anyone negatively affected by the contraception to have access to the latest information regarding Yaz litigation.
Plus, if you visit Yazlawsuitv.com , you can get a free, no-obligation consultation by simply completing the form on the right-hand side of the of the site.You can also reach them by calling toll free 1-888-770-4343
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