Saturday, March 15, 2003

FDA officials argue over safety of new arthritis drug

An external advisory panel to the US Food and Drug Administration last week rejected calls from FDA safety experts to withdraw a drug for rheumatoid arthritis from the market.

- 2003/03/15

The Arthritis Advisory Committee found that the benefits of the Aventis drug leflunomide (Arava) outweighed its rare side effects, despite an internal FDA report that said that one in 200 users may be at risk of serious acute liver injury. The report from the FDA's Office of Drug Safety, written by Dr Renan Bonnel and Dr David Graham for the advisory committee's meeting, found that there was "an absence of documented long-term benefit based on objective indices of functional ability/disability or delayed mortality." It concluded that the "risks of leflunomide greatly exceeded its benefits." Because there were safer and effective alternatives on the market, the authors recommended the drug be immediately withdrawn. That recommendation was, however, directly contradicted by senior FDA officials, including the director of the Office of Drug Safety, Dr Victor Raczkowski. He argued that many of the reports linking the drug with acute liver injury were "confounded, inconclusive, or incomplete." The latest internal conflict comes at a time when the FDA stands accused by consumer groups of paying too little attention to drug safety. These critics include the Washington based consumer group Public Citizen, which last year petitioned the FDA to withdraw leflunomide from the market. Another senior FDA officer, Dr Lawrence Goldkind, told the advisory panel that an exhaustive review of data, including large health insurance databases covering more than 50000 patients, indicated that serious liver injury was a very rare side effect of the arthritis drug. He said that there was "no consistent pattern" of toxicity, as seen with other drugs, such as troglitazone (Romozin)the diabetes drug withdrawn from the market in 2000.

SOURCE: British Medical Journal