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
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
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.