Will a Yaz or Yasmin Recall be Issued?
Despite mounting lawsuits that allege the popular birth control pills carry an increased risk of serious and potentially life threatening injuries when compared to other forms of oral contraceptive, there has been no indication that a Yaz recall or Yasmin recall is likely to be issued in the immediate future.
Many of the lawsuits filed against Bayer Pharmaceuticals over their birth control pills allege that a recall of Yaz and Yasmin should have been issued due to the risk of serious side effects. Any potential benefits provided over other available birth control pills appear to be outweighed by the increased risk of a blood clot, stroke, heart attack, pulmonary embolism, deep vein thrombosis, gallbladder disease or other potentially life threatening problems.
Calls for a Yasmin pill recall began shortly after the birth control was first introduced. In 2002, the consumer watchdog group Public Citizen listed Yasmin on their “Do Not Use” medication list because it contains drospirenone, or drsp. This untested fourth-generation progestin is also found in the Yaz pill and the generic Yasmin pill sold under the name Ocella.
Drospirenone impacts the body’s normal mechanism of regulating a balance between salt and water, which can cause elevated, and potentially life-threatening, potassium levels that cause many of the problems with Yaz and Yasmin.
In September 2009, it appeared as though the FDA may issue at least a partial recall of Yaz and Yasmin for certain batches of the drug. The agency issued a warning letter to Bayer over Yaz and Yasmin problems at the pills’ manufacturing plant in Germany, where the FDA said Bayer hid out-of-specification test results for key ingredients in the birth control pills. The FDA indicated at that time that they were concerned bad batches of Yasmin and Yaz could have been shipped to the U.S. and requested the drug maker hand over a detailed list of batches shipped to this country. Although it was not widely reported, nearly 33,000 boxes of Yaz were recalled in November 2009 over the poor manufacturing practices.
In December 2011, two FDA advisory committees were convened to review the safety problems with Yaz and Yasmin, and to evaluate whether the birth control pills should remain on the market. The panel narrowly voted against recommending a recall for Yaz and Yasmin, voting 15-11 that the benefits outweigh the health risks. However, the panel voted 21-5 to add new blood clot warnings, indicating that the prior Yaz and Yasmin labels were vague and confusing.
In April 2012, the FDA announced updated warning labels for Yaz, Yasmin and other drospirenone-based birth control pills. The new label warnings point out that some studies report side effects of the birth control pills may triple the risk of blood clots when compared to pills containing other progestins, but notes that some studies have found no increased risk.
CONTACT A YAZ / YASMIN RECALL LAWYER
The Yasmin and Yaz recall lawyers at Saiontz & Kirk, P.A. are reviewing potential lawsuits for women throughout the United States who have suffered injuries as a result of Bayer’s failure to remove these birth control pills from the market or adequately warn about the risk of serious injury. To review a potential case with an attorney, request a free consultation and claim evaluation.