06/10/2002 - Updated 06:26 AM ET

FDA allows bowel drug Lotronex back on market

By Rita Rubin, USA TODAY

Lotronex, the controversial irritable bowel syndrome drug yanked off the market in November 2000 because of sometimes deadly side effects, is expected to return to drugstores by the end of the year.

Some former users applaud the return of a medication they've described as "magical." But skeptics question how the untested "risk management program" devised by Lotronex maker GlaxoSmithKline with the Food and Drug Administration can live up to its name. On Friday, the FDA took the unprecedented step of allowing Lotronex back on the market.

Through March 8, the FDA had received reports of 113 cases of serious constipation complications and 84 cases of ischemic colitis, inflammation of the large bowel caused by reduced blood flow, in Lotronex users. Four patients died.

To enroll in Glaxo's Lotronex prescribing program, doctors must attest that they are qualified.

Glaxo is developing educational materials for doctors who don't feel qualified to prescribe Lotronex. Once doctors enroll in the prescribing program, they will receive stickers to affix to prescriptions. Pharmacists will be asked to fill only prescriptions bearing a sticker. Doctors and pharmacists are to give patients the FDA-approved "Medication Guide" for Lotronex.

Now that the FDA has approved the drug's return, "individuals can now breathe a sigh of relief in terms of access, albeit restricted, to a medicine that gave many back their day-to-day lives," says Jeffrey Roberts of Toronto, coordinator of the Lotronex Action Group, a patient group that lobbied vigorously for the drug.

Pharmacist Larry Sasich of the Public Citizen Health Research Group says the FDA didn't go nearly far enough.

Public Citizen lobbied to keep Lotronex off the market. Short of that, Sasich says, prescribing should be limited to gastroenterologists, who are better able to distinguish between irritable bowel syndrome (IBS) and other bowel diseases that have similar symptoms but should not be treated with Lotronex. And, Sasich says, registries of pharmacists, patients and prescribers should be set up. Otherwise, he says, it will be impossible to monitor Lotronex users.

The FDA first approved Lotronex in February 2000 for treating women with IBS whose predominant symptom was diarrhea. Now, the agency has approved the drug only for women with severe, diarrhea-predominant IBS who have not responded to conventional therapy. Yet, several Lotronex users who testified before an FDA advisory panel in April were men, and nothing prevents doctors from prescribing it to men as an off-label use.

The new label also advises doctors to start out prescribing 1 milligram a day, half the originally approved dose. But, says Public Citizen director Sidney Wolfe, the drug not only is ineffective at the smaller dose, but it still carries serious risks.