FDA Warnings
Since 2003, the Food and Drug Administration has sent four warning letters to Bayer, three ordering them to correct false advertising and the final one condemning the unsanitary conditions at the Bayer plant where Yaz and Yasmin are manufactured. Since being put on the market, Yaz, Yasmin and Ocella have carried “black box warnings:” the FDA’s strongest warning.The FDA, a government agency within the Department of Health and Human Services, is responsible for regulating and supervising the safety of all new and existing medicines, especially keeping unsafe drugs off the market. The FDA prevents most unsafe drugs from ever making it to the general public. In most cases, the FDA works to make sure every patient is aware of the risks associated with taking certain unsafe drugs. In rare cases, the FDA will completely recall an unsafe drug, like Vioxx, when it proves to be too dangerous. The FDA has issued numerous warnings to users of Yaz, Yasmin and Ocella and to Bayer, the manufacturer of Yaz and Yasmin.
Black Box Warnings
Yaz, Yasmin and Ocella all carry the ominous black box warning – also called a black label warning or a boxed warning. All drugs with a black box warning carry a significant risk of severe and life-threatening effects. You can read the black box warning for Yaz below:
“Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke. Additionally, there are numerous warnings associated with the use of Yaz including, but not limited to, venous and arterial thrombotic and thromboembolic events (such as myocardial infarction, thromboembolism, stroke), hepatic neoplasia, gallbladder disease, and hypertension.”
Warning Letters
July 10, 2003 – FDA warns Bayer to correct its television commercials for misleading claims that exaggerate the efficacy and diminish the risks of taking Yasmin.
October 3, 2008 - FDA warns Bayer to correct its television commercials for misleading claims that exaggerate the efficacy, diminish the risks of taking Yaz, and that suggest its use for conditions the FDA not approve it for. Bayer is forced to spend $20 million on commercials that correction their former.
March 26, 2009 - FDA warns Bayer to correct its sponsored links on internet search engines for misleading claims that exaggerate the efficacy, diminish the risks of taking Yaz, and that suggest its use for conditions the FDA not approve it for.
August 5, 2009 – FDA warns Bayer that the German facility where the Drospirenone found in Yaz and Yasmin is manufactured falls dramatically short of US standards.
