Wednesday, July 27, 2005

Pfizer Drug Giant Warned By FDA

FDA regulators warned Pfizer Inc. about "misleading promotion" of its antibiotic drug Zyvox in a professional journal, according to a letter released Tuesday, July 26, 2005.

The advertisement does not include information about Zyvox's risks, implies it is superior without supporting evidence, and claims it can treat more infections than for which it was approved, the Food and Drug Administration letter said.

The agency called on the drugmaker to halt the advertisement and take the extra step of sending out new, more accurate promotions.

"Because the violations ... are serious, we request, further, that your submission include a comprehensive plan of action to disseminate truthful, nonmisleading and complete corrective messages," the letter said.

Patients using the drug can experience blood disorders like anemia and a build-up of lactic acid in the cells and blood -- but those risks were not included in the ad, the FDA said.

Source: CNN Money, Reuters News Release - FDA warns Pfizer about drug ad: Regulators warn the drugmaker about "misleading promotion" of its antibiotic drug Zyvox. July 26, 2005: 11:36 AM EDT