Yaz Not Yet Recalled

Thursday October 23, 2014

With thousands of Yaz lawsuits pending nationwide, many believe the Yaz line of birth controls pills (which includes Yasmin, Ocella, and Gianvi) has been recalled. A recall of Yaz, however, has not yet been issued. Rather, the drug manufacturers have simply added language to the product label and official Yaz website warning users of a heightened risk of blood clots. Women represented in the Yaz litigation allege that these warnings are insufficient to prevent life-threatening blood clot injuries such as stroke and pulmonary embolism, and that the new warnings came too late for most victims.

Efforts to Issue Yaz, Yasmin & Ocella Recall

Yaz and related pills contain a synthetic progestin called drospirenone. Drospirenone is a new "fourth generation" progestin unique to the Yaz line and not used in older contraceptives. A growing number of medical studies have linked drospirenone to a heightened risk of blood clots (known as venous thromboembolism). While the FDA and drug manufacturers are aware of this increased risk, they have not acted to recall Yaz, Yasmin, Ocella, or Gianvi.

In May 2011, the FDA reported on the increased risk posed by these pills, stating, "Two recently published studies reported a greater risk of blood clots for women taking birth control pills containing drospirenone as compared to the risk in women taking birth control pills containing another progestin known as levonorgestrel." The FDA stated further, "Several epidemiological studies have reported that the risk of blood clots for women who use birth control pills containing drospirenone is higher than that for women who use birth control pills containing the progestin levonorgestrel." While the FDA did not issue a Yaz recall at that time, it cautioned patients to recognize the symptoms of a Yaz blood clot, including persistent leg pain, severe chest pain, or sudden shortness of breath.

In June 2011, the FDA revealed findings that the risk of a Yaz blood clot was 2 to 3 times greater than with other pills, such as those containing levonorgestrel. This finding was confirmed in further review by the FDA in October 2011, as well as in findings published in BMJ (formerly the "British Medical Journal"). The BMJ study also illustrated that the risk of blood clots was 6 times higher among women who took pills with drospirenone (such as Yaz, Yasmin, Ocella, and Gianvi) compared to women who did not use oral contraceptives.

The FDA indicated that its safety evaluation of Yaz and any necessary recall actions would be ongoing.

Conflict of Interest Alleged on Yaz Safety Committee

In December 2011, the FDA convened an advisory panel of medical experts to again review the safety of Yaz, Yasmin, Ocella and Gianvi. A joint committee was formed from the Advisory Committee for Reproductive Health Drugs (ACRHD) and Drug Safety and Risk Management Advisory Committee (DSaRM). Despite evidence of a heightened risk of blood clots associated with drospirenone, the joint committee opposed a Yaz recall by a vote of 15 to 11. Following the vote, a non-profit organization called Project on Government Oversight (POGO) sent a detailed letter to the FDA criticizing financial ties between the drugs' manufacturer and voting members of the joint committee. The letter cited various shortcomings in the joint committee's safety analysis and pressed for a re-evaluation of the need for a Yaz recall.

New Warning Instead of Yaz, Yasmin, Ocella Recall

In April 2012, the FDA updated its prior safety communication on the increased risk of blood clots associated with birth control pills containing drospirenone (i.e., Yaz, Yasmin, Ocella, and Gianvi). The FDA concluded that new warnings were necessary, but stopped short of issuing a Yaz recall. These new safety warnings can be seen on the official Yaz website as well as in the detailed prescribing information for the drug.

Caution Urged in Absence of Yaz Recall

Yaz, Yasmin, Ocella, and Gianvi remain on the market today. In the absence of a Yaz recall, doctors must acknowledge the heightened risk of venous thromboembolism and counsel their patients accordingly. In September 2011, the HealthDay Reporter printed the following commentary from Dr. Jennifer Wu, an obstetrician/gynecologist at Lenox Hill Hospital in New York City: "I would not start patients on this pill. Blood clots are very serious. They can kill patients. With all the options we have, we should probably start [new patients] with safer contraceptive pills."

If you or a loved one suffered a blood clot or related injury such as stroke, pulmonary embolism, deep vein thrombosis, or death, you may have significant legal rights. Speak to a Yaz lawyer today at (888) 824-5105.

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