FDA Sends Letter Requiring Bayer to Alter Marketing and Labeling for Yasmin and Yaz
Posted on behalf of Phillips Law Group on Apr 29, 2010 in Defective Drug
Bayer Healthcare is one of the leaders and giants of the pharmaceutical industry. Two of its medications that have been released in recent years, Yasmin and Yaz, generated enormous amounts of revenue as they made deep penetration into the birth control market. These products have been marketed heavily and with slick messaging, but eventually as reports of Yaz side effects and Yasmin side effects began to surface, Bayer came under intense scrutiny from officials as Yaz side effects lawyers began to file lawsuits against the manufacturer. Now comes word that the United States Food and Drug Administration (FDA) has sent a letter to Bayer Healthcare ordering it to change the labeling and marketing of these drugs.
If you or someone you love has been harmed as a result of using Yasmin or Yaz, you need to seek the help of experienced Yasmin side effects lawyers as soon as possible. Contact the trusted personal injury lawyers at Phillips Law Group today to schedule a free initial consultation.
About Yaz Side Effects and Yasmin Side Effects
When pharmaceutical products generate huge amounts of revenue, it means that a large number of people are using these drugs. When reports of side effects begin to surface in relation to these popular drugs, the amount of danger that's created is enormous given the potential number of victims involved. This appears to be the case with Yaz and Yasmin, as the drugs generated more than $1.3 billion in revenue during the first three quarters of 2009 alone. Unfortunately, Yasmin and Yaz side effects have also been identified in large numbers, and these side effects include:
- Gall bladder disease
- Pulmonary embolisms
- Heart attacks
- Deep Vein Thrombosis (DVT)
Given the reports of these Yasmin and Yaz side effects, several warnings have been issued, but the marketing of these drugs has continued. However, these marketing efforts and the information on the labels of Yaz and Yasmin are about to change as more than 1,100 Yaz and Yasmin side effects lawsuits have been filed around the country.
The FDA Requires New Yaz and Yasmin Marketing and Labeling
Recently, the FDA sent a letter to Bayer Healthcare that requires them to change their marketing and labeling. The letter is quite stern in tone and stated that, "all promotional materials for your drug product that include representations about your drug product must be promptly revised to make it consistent with the labeling changes approved in this supplement."
Basically, the labels of Yaz and Yasmin must now clearly indicate that the risks of Yaz and Yasmin side effects include the development of the conditions that are listed above. Bayer Healthcare does not have much choice but to comply with this order or it risks additional action from the FDA.