Yaz

FDA MEDICAL ALERT REGARDING YAZ RISKS

The U.S. Food and Drug Administration (FDA) has given Bayer HealthCare Pharmaceuticals, Inc. (Bayer) multiple warnings regarding the marketing of its birth control YAZ (Yasmin). One of the most recent warnings came in April of 2009, in which the FDA warned Bayer that its Internet search engine sponsored links of YAZ and other drugs were in violation of federal regulations.

According to the FDA’s warning letter on Yaz, the sponsored links were:

“Misleading because they make representations and/or suggestions about the efficacy of YAZ [and other drugs made or marketed by Bayer], but fail to communicate any risk information associated with the use of these drugs.”

According to the FDA’s warning letter on Yaz, the sponsored links were:

“Misleading because they make representations and/or suggestions about the efficacy of YAZ [and other drugs made or marketed by Bayer], but fail to communicate any risk information associated with the use of these drugs.

The letter went on to state that the sponsored links for YAZ did not adequately communicate Yaz side effects, and failed to use the required established name of the drug. Because of the aforementioned reasons, the FDA found Bayer’s Internet marketing of YAZ to be in violation of the Federal Food, Drug, and Cosmetic Act in addition to FDA regulations.

It is paramount to note that the risk information associated with using YAZ excluded by Bayer in the sponsored links includes the possibility of:

  • Blood Clots
  • Deep Vein Thrombosis
  • Hypertension
  • Gallbladder Disease
  • Stroke
  • Heart Attack
  • Other

The FDA’s warning letter stated that Bayer’s omission of YAZ’s risk information is “particularly concerning” because the oral contraceptive has a Boxed Warning. According to the FDA:

“Drugs that have special problems, particularly ones that may lead to death or serious injury, may have this warning information displayed within a box in the prescribing information. This is often referred to as a ‘boxed’ or ‘black box’ warning.

Because the makers of YAZ have repeatedly failed to communicate the risks associated with the oral contraceptive, you may be entitled to file a civil claim. As a YAZ-induced injury victim, you may be able to receive compensation for your medical costs, loss of wages, and more. Please complete the form to the right and expect a response within 24 hours. Help is on the way!

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