FDA lets bowel drug sell again, with rules aimed at preventing deaths

Friday, June 7th 2002, 12:00 am
By: News On 6

WASHINGTON (AP) _ The government is allowing a once-popular drug for irritable bowel syndrome back on the market, but with tough new restrictions aimed at mitigating side effects blamed for killing seven people.

Lotronex may be prescribed only by certain doctors enrolled in a special program, and given only to the sickest patients _ fewer than 5 percent of sufferers _ who have failed other therapies, the Food and Drug Administration said Friday.

But the FDA stopped short of even tougher restrictions recommended by its scientific advisers, including requiring doctors to have undergone special training on Lotronex's risks before prescribing it. Instead, doctors can enroll in maker GlaxoSmithKline's prescription program merely by saying they're qualified and agreeing to educate their patients about the drug.

It's extremely rare for a drug pulled off the market for safety reasons to return. But the FDA had been heavily lobbied by desperate patients who pleaded that Lotronex was the only drug that ever relieved their constant misery.

Irritable bowel syndrome afflicts millions of Americans, mostly women. It's not life-threatening but can cause continual abdominal pain, sudden and urgent need to go to the bathroom, and either frequent diarrhea, constipation or both.

When the FDA first approved Lotronex in February 2000, it was lauded as the first new therapy in decades, and some 150,000 patients began taking it.

But just nine months later, Glaxo pulled Lotronex off the market because of severe side effects that the FDA says hospitalized 163 people, caused 51 to undergo major surgery and killed at least seven.

The problems: an intestinal inflammation called ischemic colitis and severe constipation, both so severe they could kill.

Consumer advocates had opposed returning Lotronex to the market, arguing that studies showed it offered only modest overall relief _ and then just for women with the diarrhea-predominant form of the disorder. It is not proved to work for men, and is dangerous for anyone with constipation.