Yaz, Yasmin Labels Being Updated with Info on Blood Clot Studies, FDA Says

The U.S. Food & Drug Administration (FDA) announced today that it has completed its review of studies investigating the link between Yaz, Yasmin and other birth control pills that contain the synthetic progestin, drospirenone, and an increased risk of blood clots. Based on the agency’s findings, the FDA has asked the makers of Yaz, Yasmin and similar birth control pills to include information on the products’ labels regarding these studies.

Yaz and Yasmin Modified Labels

According to the FDA, the new labels for Yaz and Yasmin will now included the following information:

That some epidemiological (observational) studies reported as high as a three-fold increase in the risk of blood clots for drospirenone-containing products when compared to products containing levonorgestrel or some other progestins, whereas other epidemiological studies found no additional risk of blood clots with drospirenone-containing products

A summary of the previously released results of an FDA-funded study of the blood clot risk. That study, released last fall, found that drospirenone-containing birth control pills were associated with a 1.5-fold increase in the risk of blood clots, compared to those made with other progestins.

Other Oral Contraceptives Subject to Modified Label

In addition to Yaz and Yasmin, other birth control pills subject to the modified label include:

• Beyaz (drospirenone 3 mg, ethinyl estradiol 0.02 mg and levomefolate calcium 0.451 mg)
• Drospirenone and Ethinyl Estradiol (drospirenone 3 mg and ethinyl estradiol 0.03 mg)
• Drospirenone and Ethinyl Estradiol (drospirenone 3 mg and ethinyl estradiol 0.02 mg)
• Gianvi (drospirenone 3 mg and ethinyl estradiol 0.02 mg)
• Loryna (drospirenone 3 mg and ethinyl estradiol 0.02 mg)
• Ocella (drospirenone 3 mg and ethinyl estradiol 0.02 mg)
• Safyral (drospirenone 3 mg, ethinyl estradiol 0.03 mg, and levomefolate calcium 0.451 mg)
• Syeda (drospirenone 3 mg and ethinyl estradiol 0.03 mg)
• Zarah (drospirenone 3 mg and ethinyl estradiol 0.03 mg)

Background

In December, a panel of FDA medical advisors recommended that labels for Yaz, Yasmin and similar pills be updated with stronger warnings about their possible potential to cause serious, life threatening blood clots. The panel voted 21 to 5 in favor of changing the label for Yaz, Yasmin and similar birth control pills, holding that the then-current label warnings were inadequate.

As we’ve reported previously, since 2009, five large studies have found that drospirenone birth control pills pose a higher risk of blood clots compared to those containing an older form of progestin. Only two large studies, both funded by Bayer, have failed to find a higher risk.

Yaz, Yasmin and similar birth control pills have been named in thousands of lawsuits alleging they caused users to suffer serious, life-threatening side effects including blood clots, strokes and gallbladder problems. Most of the cases have been consolidated in the Yasmin and Yaz (Drospirenone) Marketing, Sales Practices and Products Liability Litigation (MDL No. 2100) currently pending before Judge David Herndon in the U.S. District Court for the Southern District of Illinois. Late last year, the first bellwether trials, or test cases, scheduled to start in that litigation were postponed indefinitely. Judge Herndon instead ordered the parties to begin settlement negotiations, and appointed a special master, George Washington law professor Stephen Saltzburg, to mediate.

In Feburary, Bayer revealed in its Annual Report that it had settled somewhere in the neighborhood of 70 Yaz and Yasmin lawsuits filed by women who allegedly suffered blood clots, deep vein thrombosis, pulmonary embolism, strokes and other serious complications due to their use of the medications. Bayer did not reveal the terms of the settlements, nor did it admit any fault.