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FDA causes unnecessary scare about common painkillers

April 25, 2007

WINSTON-SALEM, N.C. - The U.S. Food and Drug Administration (FDA) has caused an unnecessary scare about some pain relievers by adding a warning to drugs that are safe, says Curt Furberg, M.D., Ph.D., from Wake Forest University School of Medicine. At the same time, he says the agency has failed to recognize the harm of a pain reliever that should be taken off the market.

"The FDA is adding 'black box' warnings to all prescription and over-the-counter pain relievers - even to naproxen - which the evidence shows is safe," said Furberg, who serves on the FDA Drug Safety and Risk Management Advisory Committee. "This is based on the false assumption that all nonsteroidal anti-inflammatory drugs increase the risk of heart attacks. In fact, there are major differences between these agents."

In a commentary published by Trials (http://www.trialsjournal.com/content/8/1/13), an online journal of BioMed Central, Furberg says the FDA has failed to recognize current scientific evidence when it made decisions on the safety of nonsteroidal anti-inflammatory drugs (NSAIDs) that are often used to treat the pain or inflammation from arthritis.

The most commonly used NSAIDs are ibuprofen (Advil®), naproxen (Aleve®), and diclofenac (Voltaren®). There are more than a dozen others, including drugs such as celecoxib (Celebrex®) that are in a special class known as selective COX-2 inhibitors because of the hormone they target. The other NSAIDs are known as "non-selective."

Furberg said while the evidence for the non-selective NSAIDs is somewhat limited, an analysis combining several small studies found that high doses (500 mg twice daily) of Aleve were not associated with an increased risk of heart attacks compared to a placebo, or an inactive pill.

On the other hand, high doses of Advil (800 mg three times a day) and Voltaren (75 mg twice daily) were associated with rates of heart attack that were 51 percent and 63 percent higher, respectively, than placebo. An analysis of a large number of trials comparing COX-2 inhibitors to other NSAIDs found similar results - that Voltaren was estimated to increase vascular risk by about 70 percent over Aleve.

"Naproxen does not increase the risk of heart attacks and ought to be a painkiller of choice," said Furberg. "On the other hand, Voltaren carries the same risk as the harmful COX-2 inhibitors Bextra® and Vioxx®, which have been taken off the market.

"The FDA has failed to recognize the evidence that the risk of heart attack varies substantially among this group of drugs and that Voltaren has the highest risk of all. Since it is the most commonly used NSAID, the unrecognized harm it has caused worldwide could be enormous."

The European Regulatory Agency has reviewed the same evidence that the FDA considered and reached entirely different conclusions, said Furberg. He said this suggests that the decisions are not based on scientific evidence.

With Celebrex, the FDA didn't follow the recommendations of its Advisory Committee to substantially restrict the drug's use. Instead, it required only a "vaguely worded" black box warning, said Furberg. European countries require clear warnings for patients at high risk of heart attacks and have said COX-2 inhibitors should not be taken by patients with heart disease.

With the non-selective NSAIDs, Europe has given a "clean bill of health" to the agents and the FDA has judged them to have similar risks to Celebrex and is adding "black box" warnings.

"Decisions by regulatory agencies are expected to follow explicit regulations and should be evidence-based," said Furberg. "Scientific studies point to clinically important differences among the non-selective NSAIDs, which the FDA has not recognized. It's time for the FDA to set the record straight."

Wake Forest University Baptist Medical Center