FDA permits marketing of drug withdrawn in 2000

The reintroduction on the drug Lotronex, used to treat irritable bowel syndrome, continues to endanger patients and should be taken off the market again, Public Citizen Health Research Group Director Dr. Sidney Wolfe told members of the Food and Drug Administration’s (FDA) Drug Safety Advisory Committee recently.

In his testimony, Wolfe outlined how a recent analysis conducted by the drug’s manufacturer, GlaxoSmithKline, and the FDA, failed to provide sufficient evidence to conclude the drug should remain on the market.

Lotronex, approved in February 2000 to treat irritable bowel syndrome (IBS), was withdrawn from the market in November 2000 because of dangerous adverse effects experienced by patients taking it. Public Citizen in August 2000 petitioned the FDA to remove the drug because of evidence it caused ischemic colitis, a life-threatening condition in which bowel tissue dies as a result of a lack of blood flow to the colon.

The drug, also known as alosetron, was reintroduced in November 2002 under the guidelines that physicians who want to prescribe the drug must state that they are qualified to diagnose IBS and manage ischemic colitis and that they understand the risks associated with Lotronex. However, the guidelines did not include a way to verify the doctors’ qualifications or check to ensure patients have been informed of the drug’s risks. The guidelines also assume that all prescribing doctors report adverse reactions. According to cases spontaneously reported, the rate of ischemic colitis (0.85 per 1,000) is actually higher than the rate of spontaneous reports during the earlier 2000 marketing (0.31 per 1,000).

“When I testified before this committee in 2002, I stated that, ‘The reintroduction of Lotronex into the market, even with the restrictions proposed by Glaxo, would be a serious public health mistake, likely, if not certain, to result in the need to ban the drug again,’” Wolfe said in testimony to the committee. “It is time to end this failed effort to resuscitate marketing and to take alosetron off the market again. … Given the marginal evidence of effectiveness and the continuing serious risks of the drug, Glaxo’s suggestion to relax the restrictions on availability of alosetron to increase its use is nothing but ghoulish.”

SOURCE: “New Data Reconfirm Dangers of Controversial Drug Lotronex,” Public Citizen, May 5, 2004.