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Yasmin and Yaz Side Effects - Birth Control Pill Problems Georgia and Florida

By Mark Zamora

The FDA has told Bayer to makes changes to its marketing materials for the birth control drugs Yaz and Yasmine. The FDA's directive was issued after Bayer's announcement that it was adding new safety information regarding the risk of blood clots the drugs' labels.

The FDA's letter says: '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, including any new safety information.' The agency said revisions must include 'prominent disclosure of the important new safety information.

From the letter:

 

This 'Prior Approval' supplemental new drug application provides for the addition of new information in the Thromboembolism subsection of the Thromboembolic Disorders and other Vascular Problems subsection of WARNINGS. The new information concerns the relative risks of thromboembolism in women using YASMIN compared to those in women using combination oral contraceptives containing other progestins.

 

Call Attorney Mark Zamora (Georgia/Florida) if you'd like more information. 404-451-7781

Full post as published by Trial Lawyer Resource Center on April 18, 2010 (boomark / email).