Lotronex

Lotronex, a popular prescription treatment for women suffering irritable bowel syndrome has been pulled off the market amidst growing reports linking it to severe intestinal side effects, including some deaths.

Manufacturer Glaxo Wellcome Inc. withdrew Lotronex, just nine months after it began selling the drug with great fanfare.

The problem, Lotronex can cause serious side effects, including a life-threatening intestinal inflammation called ischemic colitis, and constipation so severe that some patients needed parts of their intestines surgically removed.

A review of FDA's records by The Associated Press indicates the agency knows of at least eight women who died with intestinal side effects while taking Lotronex.

The agency also says at least 70 additional cases of ischemic colitis or severe constipation probably were caused by Lotronex. Two-thirds of those women needed hospitalization.

Manufacturer Glaxo Wellcome Inc. contends Lotronex is safe when used by the right patient, and calls it no more risky than some other big-selling medicines. But, saying it was under orders from FDA, the company announced Tuesday that it would cease distribution of Lotronex immediately and recall the drug from pharmacies.

The FDA says it offered Glaxo an alternative to yanking the drug from the market, but the company rejected that proposal.

Lotronex initially was welcomed as the first new therapy in decades for irritable bowel syndrome, a mysterious disorder that affects up to 15 percent of Americans, mostly women. IBS is not life-threatening but can cause misery. It involves chronic or recurrent abdominal pain, the sudden and urgent need for a bowel movement and either frequent diarrhea, constipation or both.

In studies, Lotronex offered only modest relief to women whose main IBS symptom was diarrhea. It did not work for men, and was declared downright dangerous for anyone with constipation.

The FDA warned when it approved Lotronex last February that it might cause serious side effects because four women in clinical trials suffered ischemic colitis. But the agency approved the drug anyway, saying the mild cases healed once the women stopped taking Lotronex and that IBS sufferers needed a new option.

But within months, the FDA was receiving numerous reports of increasingly serious reactions. By August, it ordered Glaxo to attach special safety warnings to every bottle of Lotronex sold, urging doctors not to prescribe it to patients with constipation or other risk factors and telling women to stop using it at the first sign of trouble.

But just weeks later, FDA learned of the first death.

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