FDA Advisory Panel Recommends Yaz/Yasmin Label Include Blood Clot Warning
Bernstein Liebhard LLP supports a federal advisory panel’s recommendation that the U.S. Food and Drug Administration (“FDA”) update the labeling on Yaz and Yasmin to include information warning users that they are at an increased risk for developing blood clots.* The panel, which met on December 8, 2011, voted 21-5 that the current labeling is inadequate and should be revised in order to warn consumers about potential risks associated with birth control pills containing drospirenone. The current Yaz and Yasmin label only informs women about conflicting studies on blood clot risks. The panelists said that the FDA should require Bayer, the drugs’ manufacturer, to change the labeling so that it is clear to Yaz and Yasmin users that the birth control pills can cause blood clots in the legs and lungs. Moreover, the label should convey that these blood clots can be fatal. Experts within a field serve on advisory panels. The FDA and the drug manufacturers supply the panel with information, which they review and discuss. Although the advisory panel votes on whether regulatory actions should be taken, the FDA is not required to follow the recommendations of the panel.
Previous FDA Review Of Yaz And Yasmin’s Link To Blood Clots
In May 2011, the FDA announced that it would commence a safety review in order to evaluate the potential Yaz/Yasmin link to blood clots. On September 26, 2011, the FDA issued a drug safety communication on its website stating that “it remains concerned” that Yaz, Yasmin and other birth control pills containing drospirenone put users at a higher risk for developing blood clots than other types of birth control pills.** The safety communication was issued in response to a study, which found that women who take drospirenone-laden birth control pills, such as Yaz or Yasmin, face a 1 ½ times greater risk of developing blood clots when compared with women who use other, older types of birth control pills. The FDA-funded study, which observed the side effects of Yaz and Yasmin, involved 800,000 women in the United States. In addition to this particular study, the FDA reviewed six other epidemiological studies on the side effects of Yaz and Yasmin prior to issuing the drug safety communication. The FDA also advised health professionals to inform women taking drospirenone-laden birth control pills about the potential risk of blood clots.
As part of the ongoing safety review, last week’s advisory panel convened to discuss whether regulatory action should be taken. The panel evaluated the side effects of Yaz and Yasmin, and recommended that the FDA upgrade the drugs’ warning label to protect consumers from the potential risk of blood clots. The panel also noted that there is a need for better, more conclusive research regarding the risks associated with drospirenone-laden birth control pills, such as Yaz or Yasmin.
In August 2009, a study published in the British Medical Journal Online found that Yaz and Yasmin users were at an increased risk for developing blood clots when compared to those using other oral contraceptives. Since that time, Bernstein Liebhard LLP has provided a wealth of consumer information concerning Yaz and Yasmin on its website, www.consumerinjurylawyers.com. If you or a loved one took Yaz or Yasmin and developed a blood clot, you may be entitled to compensation for medical bills, pain and suffering, lost wages and other injuries.
About Bernstein Liebhard LLP
Bernstein Liebhard LLP is a New York-based law firm exclusively representing injured persons in complex individual and class action lawsuits nationwide since 1993, including those who have been harmed by dangerous drugs, defective medical devices and consumer products. The firm has been named by The National Law Journal to the “Plaintiffs’ Hot List,” recognizing the top plaintiffs’ firms in the country for the past nine consecutive years. Only two firms in the country have been selected for the Hot List nine years in a row.
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