A House subcommittee chairman said yesterday that the health risks of the popular prescription painkiller Zomax suggest that "this is not a product that should be restored to the marketplace."
After reports of five deaths and more than 1,000 allergic reactions, the drug's manufacturer, Johnson & Johnson, temporarily withdrew the drug from the market in early March.
At the time, both company and Food and Drug Administration spokesmen emphasized that the adverse reactions appeared to be rare and that the problem could be solved with labeling changes warning physicians about potential problems.
Yesterday, however, in an appearance before the House intergovernmental relations and human resources subcommittee chaired by Rep. Ted Weiss (D-N.Y.), FDA Commissioner Dr. Arthur Hull Hayes Jr. outlined major barriers to the reintroduction of Zomax to the market.
They include convincing the government that short-term use of the drug does not expose a patient to life-threatening reactions or that its advantage over other drugs is enough to justify the risk to certain people.
Zomax, first marketed in late 1980 by a Johnson & Johnson subsidiary, McNeil Pharmaceutical, has been prescribed to more than 15 million patients to relieve pain.
It was advertised as the first non-narcotic and, therefore, non-addictive painkiller shown to provide greater relief than aspirin.
The deaths from Zomax resulted from an anaphylactic reaction, a condition of hypersensitivity to substances caused by previous exposure and resulting in shock.
Hayes noted that increased risk of a severe allergic reaction appears to be "real and that it relates both to the drug itself and to its mode of use."
In particular, he said, both the company and the agency believe that there is added risk when the drug is used on an intermittent regimen to control pain.
Because of this problem, Hayes and Dr. Robert Temple, head of new drug evaluation for the FDA, noted that any attempt by Johnson & Johnson to get the drug approved for treatment of recurring problems would first require studies to prove that it has significant advantages that would outweigh risks. Animal studies show that the drug may pose a risk of cancer to humans.
Despite prodding from Weiss, Hayes stressed that he had made "no judgment" about Zomax's future. Accusing him of "obfuscation," Weiss said that his reading of the testimony indicated that "this is not a product that should be restored to the marketplace."
While much of the day-long hearing focused on the future of Zomax, Weiss also raised questions about the government's previous handling of the drug, including FDA's post-marketing surveillance system and the original decision to market the drug.
A panel of doctors from around the country, including three who experienced life-threatening reactions after taking the drug, were unanimous yesterday in recommending that it not be allowed back on the market.
"It's hard to accept putting a drug on the market when there are substitutes," said Dr. Jack Yoffa, of Syracuse, N.Y. Both Yoffa and the FDA indicated that reported deaths had more than doubled since the drug was taken off the market with great fanfare in March.
Johnson & Johnson said in a statement that the company "believes that Zomax is a well-researched, non-narcotic, non-addictive pain reliever than has benefited millions of patients since it was introduced."