FDA Warns OxyContin Maker Over AdsJan 22, 2003 | AP
The maker of the controversial painkiller OxyContin placed ads in a popular medical journal that "grossly overstate" the drug's safety, the Food and Drug Administration said in an unusually stern warning released Wednesday.
The body of the two ads, which ran in The Journal of the American Medical Association last fall, doesn't say OxyContin can cause fatal side effects or discuss its potential for abuse, the FDA said.
Those serious warnings were relegated to fine print in violation of federal rules governing prescription drug ads, the agency said.
The ads also suggested broader use of OxyContin than is approved, a combination of violations that "is especially egregious and alarming in its potential impact on the public health," says the FDA warning letter to OxyContin maker Purdue Pharma.
The letter, written Friday but released to the public Wednesday, orders Purdue to pull any additional advertisements with similar problems, and to tell FDA by Friday how it would disseminate accurate OxyContin information to the thousands of physicians who saw the misleading ads.
Purdue called the FDA's letter "the result of an honest misunderstanding" about how detailed risk warnings must be in the body of an ad instead of in the fine print on the next page. Purdue denied that its wording of OxyContin's benefits suggested broader uses of the painkiller.
"We do not believe that the ads will mislead physicians about the safety risks of OxyContin," said a company statement. Still, Purdue discontinued the ads, saying, "We want our efforts to be a model for compliance in the industry."
OxyContin is a long-lasting version of oxycodone, a narcotic considered important therapy for many patients suffering long-term, severe pain from cancer or other illnesses. When swallowed whole, the tablet provides 12 hours of pain relief.
But if chewed, snorted or injected, OxyContin produces a quick and potentially lethal high. It has been linked to more than 100 deaths and bears the FDA's strongest warning label, which says the drug is as potentially addictive as morphine.
The FDA's strongly worded letter comes as the agency is under fire for how it handles misleading drug advertisements. Last month, congressional investigators said misleading TV ads aimed at consumers often are off the air by the time the FDA chastises their makers. A critic contended that FDA warnings ordering untruthful ads to be pulled have dropped by almost two-thirds in the last year.