FDA Evaluates Risk Factors of Yaz-Yazmin for Blood Clots

Yaz and Yasmin are oral contraceptive drugs that have been the subject of recent lawsuits because of their link to an increased risk of blood clots. They are one of the fourth generation drugs for prevention of pregnancy. They are the first drugs to use drospirenone, a synthetic progestin. Yaz contains 3mg of drospirenone and 0.02 mg of ethinyl estradiol per tablet, where as Yasmin contains 3 mg of drospirenone and 0.03 mg of ethinyl estradiol per tablet. Generic versions of these drugs are also available in the market. The manufacturer of these drugs Bayer pharmaceutical have faced the wrath of the Food & Drug Administration (“FDA”) from time to time.

In 2006, Yaz and Yasmin were approved by the FDA as prescription contraceptives. Later that year, the FDA also approved Yaz for treatment of premenstrual dysphoric disorder (PMDD) and moderate acne too. In the United Stated, Yasmin is still approved only for contraceptive use, but doctors can prescribe it for “off-label” uses such as acne and PMDD.

Bayer aggressively marketed Yaz/Yasmin in their advertisement for treatments that had not been approved by the FDA. In October 2008, the FDA issued a warning letter to Bayer pharmaceuticals. The FDA condemned the manufacturer of Yaz-Yasmin for providing misleading information in television and web site advertisements. FDA has said in its letter that television advertisements are showing misleading information regarding the drugs’ uses, overstating drugs’ effectiveness, and promoting the drugs for uses which are not approved. The letter also alleged that these advertisements had understated the side effects of this drug. The FDA further added that although this drug could cause severe side effects, it was promoted as the safest oral contraceptive, which was misleading.

New corrected ads were released by Bayer in January 2009. Even these revised ads could not escape another warning letter from the FDA. Another warning letter was issued in 2009. This second letter scolded company for providing misleading facts about this drug through online advertisements. In 2009, many lawsuits were filed against Bayer related to side effects from these drugs such as deep vein thrombosis (DVT), pulmonary embolism, cerebral damages, and even death.
The FDA issued another warning letter to the Bayer Pharmaceuticals regarding quality control. The FDA inspected its Germany plant, where one of the ingredients for Yaz-Yasmin is manufactured, and found quality control problems there. In its notice, the FDA said that the average test method used by Bayer was not adequate, as the average was within parameters, but individual batches violated the parameters and they were out of specification (OOS). The FDA letter did not report the test results for individual batches. The FDA also asked Bayer to provide list of the OOS batches shipped to US. These measures by the FDA were intended to prevent quality control problems, so that they could not occur again.

In 2010, safety label changes for Yaz and Yasmin were approved by the FDA Center for Drug Evaluation and Research.

Recently, the FDA announced that it is evaluating the risk factors related to blood clots from Yaz and Yasmin. These drugs are oral contraceptive pills and have been associated with severe side effects such as blood clots, deep vain thrombosis (DVT), pulmonary embolism, heart problems, problems of the kidney and liver, and many more side effects. There are many lawsuits alleging that use of these medicines has resulted in severe side effects, including blood clots, gallbladder diseases, pulmonary embolism, DVT and heart attacks. The relative safety of these drugs has been questioned by some for a long period, and these health and safety advocates welcomed the FDA’s latest plans to review the side effects of these drugs.

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