Zyvox® Advertising Warning Letter
Since its approval for sale in the U.S. Zyvox® has been the subject of a “Warning Letter” issued to Pfizer, Inc. by the FDA’s Division of Drug Marketing, Advertising and Communications ("DDMAC"). In the letter, the DDMAC contends that certain advertising used by Pfizer to promote Zyvox® was misleading, lacked fair balance and failed to reveal important risk information. 

According to DDMAC, "The ad also fails to include additional precautions regarding peripheral and optic neuropathy….Your ad presents an unsubstantiated implied superiority claim, broadens the indication for ZYVOX®, fails to reveal important risk information associated with the use of ZYVOX® and lacks fair balance. The ad therefore misbrands your drug in violation of the Act…"

For the full text of this Warning Letter, go to www.fda.gov/foi/warning_letters/g5416d.pdf - 08-02-2005 - Text Version.

If you or a loved one suffered from blindness, ongoing visual disturbances, pain or numbness/loss of sensation in the arms or legs while taking Zyvox^®, or if you or a loved suffered from optic or peripheral neuropathy while taking Zyvox^® and you have questions about your legal rights, please click HERE to find out about your potential legal rights.