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New Data Confirm Dangers of Controversial Drug Lotronex

April 18, 2001

New Data Confirm Dangers of Controversial Drug Lotronex

FDA Should Not Put Drug Back on Market; Should Allow Use Only on Experimental, Restricted Basis, Public Citizen Says

WASHINGTON, D.C. — New data obtained by Public Citizen confirm the dangers of the controversial drug Lotronex, indicating that the government would be reckless to consider remarketing the drug, Public Citizen said today in a letter to the U.S. Food and Drug Administration (FDA). Instead, if the government decides to allow patients to take the drug again, it should do so only on an experimental and highly restricted basis. The letter was sent to Bernard Schwetz, the FDA’s acting principal deputy commissioner.

Lotronex was used to treat irritable bowel syndrome (IBS) until it was withdrawn from the market last November because of dangerous adverse effects experienced by some patients taking it.

The new data show that through the end of 2000, 63 patients taking Lotronex experienced ischemic colitis (an interruption of the blood supply to the large intestine, which results in severe damage to the intestine) — up from 49 cases reported in mid-November. And 75 patients experienced severe constipation, up from 21 at that time. Most of the patients experiencing these problems required hospitalization. In all, the FDA has on record 141 cases of severe gastrointestinal complications in patients who took the drug — twice as many as in early November, before the drug was withdrawn. (Although the drug was removed from the market, patients could have continued taking it until their supplies ran out or there may have been a delay in reporting the adverse effect.)

Because of pressure from the drug industry and patient groups, the FDA apparently is considering putting Lotronex back on the market. But the drug poses too many dangers to be made widely available, Public Citizen said. Instead, the drug should be given to patients only under several conditions. First, the drug should be limited to patients who have previously used it and have not experienced adverse effects. Second, patients should be given an informed consent sheet explaining the potential dangers of the drug. Finally, a registry of all patients taking the drug and their physicians should be kept so the patients can be monitored.

“If anything other than this approach is used, the toll of needless deaths and serious injuries and the repeat ban that will inevitably occur will be on the hands of those FDA officials responsible for such a reckless remarketing,” Public Citizen’s letter said.