Bayer has become somewhat of a federal poster child for the FDA's request for the placement of corrective advertising, which is designed to correct misleading messages.
In 2009, for example, as the Federal Register reads, Bayer HealthCare Pharmaceuticals produced and aired corrective DTC advertising for Yaz, a birth control pill, following a warning from FDA regarding misleading claims.
Bayers Yaz ads, according to the FDAs 2008 warning letter, were misleading because they broaden the drug's indication (to include PMS), overstate the efficacy of Yaz, and minimize serious risks associated with the use of the drug. Thus, the TV Ads misbrand the drug in violation of federal statutes and regulations. Info: yaz recall
Who knows how often the understated risks of Yaz in advertising slipped under a consumers radar and stimulated interest in the drug? Yaz lawsuits have been filed to protect the rights of the injured to compensation. Info: yaz lawsuit
Based on scientific information available at the time, the FDA in April 2012 updated the warnings and precautions for Yaz/Yasmin/ocella to include the increased risks of thromboembolic disorders and other vascular problems.
Yaz is a combination oral contraceptive that contains drospirenone, or DRSP, and ethinyl estradiol. In addition to pregnancy prevention, the drug is approved also to treat premenstrual dysphoric disorder, which is not the same as premenstrual syndrome, and moderate acne for patients who are at least 14 years old.
Related articles
US Drug Watchdog Now Urges First Year Users of the Birth Control Pills Called Yaz Yasmin Birth Control Who Had a Heart Attack or Stroke to Call the Johnson Law Group(prweb.com)
DrugRisk Adds New Yaz Blood Clot Warning, Lawsuit News(virtual-strategy.com)
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