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Shots - Health Blog
Fri September 2, 2011
FDA Chides Pfizer For Omitting Drug Risks On Lipitor Website
Somebody who didn't like the way Pfizer was promoting a bunch of its drugs on a website for cholesterol-fighter Lipitor tipped off the Food and Drug Administration about it. And the agency agreed.
In a written reprimand, the agency faulted Pfizer for failing to tell people about risks from Caduet, a pill to treat high cholesterol and blood pressure; Norvasc, for high blood pressure; and Chantix, a pill to help people quit smoking.
The basic problem, according to the FDA, was that links to pages with more information about these drugs featured language describing what the piils do without mentioning any of the risks they pose.
"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," the FDA wrote.
Pfizer has until Sept. 14 to respond to the agency's letter. In an email to Shots, a Pfizer spokesman said the company "is in the process of reviewing and responding to the FDA letter and has already removed the cited content from the Lipitor website."
The Pfizer letter is just the latest FDA enforcement action spawned by a "bad ads" initiative launched in May 2010. FDA Commissioner Margert Hamburg asked doctors, nurses and pharmacists around the country to become tipster and help root out false and misleading marketing of drugs.
In a report on how things are going, the agency said in the first year it received 328 tips, more than triple the yearly average before the call for help. Most came from health professionals, and 87 of those prompted a careful look by the FDA. For a look at some of the problems that resulted in action, you can find links to five agency letters here.
For all the hoopla, most doctors remain unaware of the tip program, according to a survey highlighted by the blog Pharmalot in March. Speaking of, I was unaware of the latest action against Pfizer until Pharmalot blogged about it this morning.
For more on how the tip program is supposed to work, check out the FDA video.