Pfizer's Lipitor website touted the efficacy of Caduet, Chantix and Norvasc but the site failed to balance those claims by providing any risk information for the drugs, according to an “untitled letter” from the FDA's Division of Drug Marketing, Advertising and Communication (DDMAC).
Acting on a complaint that had been made through the agency's Bad Ad program, which encourages both 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 Re-sources” section of Lipitor.com. That section listed, under a headline which read “Medicines That May Treat Heart Disease Risk Factors,” the three drugs, all of which are from Pfizer.
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 webpage misleadingly suggests that these drugs are safer than have been demonstrated,” said the letter, which also noted that while the company provided links to the respective product sites, “this is insufficient to mitigate the misleading omission of risk information.”