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Yasmin and Yaz Should Have Stronger Warning Labels According to FDA

An FDA panel voted recently to strengthen warning labels for birth control medications Yaz and Yasmin, in light of new data suggesting a higher risk of blood clots associated with the drugs, compared to other contraceptive pills. The panel voted 21-5 on December 8, indicating that labeling on the medications manufactured by Bayer is inadequate …

An FDA panel voted recently to strengthen warning labels for birth control medications Yaz and Yasmin, in light of new data suggesting a higher risk of blood clots associated with the drugs, compared to other contraceptive pills. The panel voted 21-5 on December 8, indicating that labeling on the medications manufactured by Bayer is inadequate and needs to include more information about the potential risk of blood clots in the legs and lungs. Yaz, Yasmin, and similar contraceptive pills use a man-made hormone called drospirenone, which mimics the female hormone progesterone. Unfortunately, recent research has indicated that women taking Yasmin or Yaz may have a 1.5 to 3 times increased risk of developing dangerous blood clots. If you have suffered from an adverse side effect and you believe Yaz or Yasmin to be the cause, contact an experienced Oklahoma personal injury attorney today.

Yaz and Yasmin Uses

Yasmin garnered FDA approval in 2001 and was the first birth control pill to contain the unique progestin, drospirenone. Yaz was approved by the FDA in 2006 and quickly grew into the best-selling birth control pill in the United States within just two years. The contraceptive pill was backed by hundreds of millions of dollars in magazine and television advertising touting the medication as effective against acne and other hormonal side effects, with peak sales of $781 million in 2009. However, prescriptions for Yaz have decreased more than 80% in the last two years amid safety concerns about the drug.

Using the catchy slogan, “beyond birth control,” Bayer’s advertisements claimed Yaz as a drug with “lifestyle” benefits over older contraceptive medications. However, after information was released indicating that studies found a heightened risk of blood clots in Yaz patients, Bayer was forced to run corrective advertisements by the FDA, which said the company’s marketing campaign overstated Yaz’s effectiveness in treating certain conditions, while using distracting music and visual effects to downplay the drug’s side effects.

Yaz and Yasmin May Increase Blood Clot Risk

In a previous vote, panelists voted 15-11 that Yasmin and Yaz should stay on the market because they remain a beneficial option for preventing pregnancy. Unfortunately, five large studies published since 2009 have suggested that drospirenone-containing products like Yasmin and Yaz carry a slightly higher risk of blood clots than older birth control pills. This information is significant, since blood clots can lead to life-threatening events like heart attacks, strokes and blockages in lungs or blood vessels. The most recent study conducted by the FDA found that women taking Yasmin had a 75% higher chance of suffering a blood clot than than patients taking a combination of older drugs. In light of this side effect information, 4,000 to 6,000 Yaz and Yasmin patients throughout the U.S. have filed personal injury lawsuits against Bayer. Although the FDA has not set a specific timeline for changes in Yaz and Yasmin’s safety labeling, the recent FDA panel vote is a step in the right direction. If you or a loved one has been affected by the oral contraceptives, Yaz or Yasmin, contact an OK personal injury attorney to discuss your legal options.

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