Pfizer's Lipitor website touted the efficacy of Caduet, Chantix and Norvasc but failed to balance those claims with risk info for the drugs, according to an “untitled letter” from FDA's Division of Drug Marketing, Advertising and Communication (DDMAC).
Acting on a complaint made through the agency's Bad Ad program, which encourages physicians and the public to report sketchy claims made in drug advertising, the FDA asked the company to cut it out. At issue in the August 31 letter was the “Online Resources” section of Lipitor.com, which listed, under the headline “Medicines That May Treat Heart Disease Risk Factors,” the three Pfizer drugs. Caduet is a combo drug pairing atorvastatin (Lipitor), for high cholesterol, with calcium channel blocker amlodipine (Norvasc) for hypertension; and Norvasc in standalone form. Chantix, the letter noted, carries a “Boxed Warning” on dangerous neuropsychiatric side effects.
“By omitting the most serious and frequently occurring risks associated with Caduet, Chantix and Norvasc, the webpagemisleadingly suggests that these drugs are safer than have been demonstrated,” said the letter, which noted that while the company provided links to the product sites, “this is insufficient to mitigate the misleading omission of risk information.”