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FDA Mulls Comeback of Drug Linked to 5 Deaths

Lotronex might return for some patients, officials say

THURSDAY, May 17, 2001 (HealthDayNews) -- Six months after a bowel drug linked to at least five deaths was withdrawn from pharmacies, U.S. drug officials are considering letting the company that makes the pills to put them back on the market.

The Food and Drug Administration is taking another look at the recall of alosetron hydrochloride, or Lotronex, a highly effective but potentially dangerous compound to treat irritable bowel syndrome in women, agency and industry sources say. No one would speculate on when the drug might be back on the market.

Lotronex, made by GlaxoSmithKline, was taken off the shelves last November after being linked to dozens of cases of intestinal damage and severe constipation; at least five people died. The FDA approved Lotronex in February 2000 after giving it an expedited, "fast track" review.

While clinical trials of the drug showed few side effects, reports of serious, and even deadly, adverse reactions to the medication began cropping up shortly after its approval. Rather than pull the drug, however, the FDA issued guidelines informing patients about the risk of bowel problems linked to Lotronex.

"That decision was to prove fatal," writes Richard Horton, in a letter in this week's issue of the British medical journal, The Lancet. Horton, the journal's editor, harshly criticized the FDA for its handling of Lotronex, claiming top-tier agency officials "subverted" the objections of lower-level scientists to the approval of the drug, and that the FDA and the company have been engaged in "back-channel" discussions about the pill since its withdrawal.

Horton calls the Lotronex affair "a serious erosion of integrity within the FDA, and in particular [its drug evaluation branch], whose operating budget now depends greatly on industry money." Horton is referring to the 1992 Prescription Drug User Fee Act that let the FDA increase its regulators and fund that expansion with industry money in order to speed promising drugs to the market.

What's more, Horton says, the Lotronex situation reflects a general pro-industry attitude pervasive at the agency. And that has eroded the public's trust in the nation's drug review process.

Dr. Victor Raczkowski, the FDA official who oversaw approval of Lotronex, rejected the notion that the FDA and Glaxo engaged in secret dealings to bring back the drug. Talks occurred among officials at many levels, he says, but, "the results of these discussions have been shared openly within the FDA. There is nothing secretive about this process."

Raczkowski says the agency has been bombarded with interest in Lotronex since its withdrawal. "What we have seen with Lotronex is that there are patients who are asking for access to the drug, and access for those patients who are severely limited by irritable bowel syndrome are a concern for the FDA."

Raczkowski would not discuss the terms under which Lotronex might win back its approval, but he says any such plan would have to satisfy the FDA's safety concerns.

Ramona DuBose, a spokeswoman for GlaxoSmithKline, says Horton's accusations about clandestine dealings between her company and regulators are "absolutely not true."

However, DuBose acknowledges that the company and the FDA have been discussing reintroducing the bowel drug since January after "literally thousands" of patients and health care providers contacted Glaxo, upset about the recall.

"We are in discussions with the FDA to see if there is a way that Lotronex could be made available to patients in a way that would provide benefit to [them] but would minimize any potential risks," she says.

Public Citizen, a consumer watchdog group that pushed to have Lotronex pulled, says it has new data showing that 63 patients developed intestinal damage while taking the drug, up from 49 such cases reported through last November.

The group also says 75 Lotronex users reported severe constipation, nearly four times the earlier figure of 21. Of these 138 cases, 96 required hospitalization, according to the group, which notes three other cases of bowel-related complications associated with the drug, bringing the total number of adverse events to 141. (DuBose calls these new figures "misleading.")

In a recent letter to the FDA, Public Citizen argues that Lotronex is still too dangerous to be made widely available again. However, the group says, it could be given to patients who previously used the drug without serious side effects, and in the context of closely monitored clinical trials.

"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," the letter says.

Nancy Norton, president and founder of the International Foundation for Functional Gastrointestinal Disorders, says the Milwaukee, Wis., group was flooded with phone calls from concerned women after Glaxo withdrew Lotronex. "For hundreds of thousands of people this drug had turned their life around," Norton says.

While Norton is unwilling to take a position on whether the drug deserves a second chance, she does believe that, were it to return to the market, regulators would need to be explicit about which sub-groups of women should receive it. "We are relying upon the FDA to make that choice based on the data that's provided to them," she says.

What To Do

Irritable bowel syndrome affects as many as 15 percent of Americans. The malady, which strikes women three times as much as it does men, occurs in two forms, one accompanied by diarrhea and the other by constipation. Lotronex was intended for use only by women with the diarrheal form of the condition.

For more on Lotronex, try the FDA.

For more on irritable bowel syndrome, check out the IBS Group.

Or you may want to take a look at HealthDay' previous stories on Lotronex.

And if you're interested in clinical trials for irritable bowel syndrome, visit Veritas Medicine.

SOURCES: Interviews with Victor Raczkowski, M.D., FDA deputy director, office of drug evaluation III; Ramona DuBose, spokeswoman, GlaxoSmithKline, Research Triangle Park, N.C.; and Nancy Norton, president and founder of the International Foundation for Functional Gastrointestinal Disorders, Milwaukee, Wis.; Public Citizen; May 19, 2001 The Lancet
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