WASHINGTON — Senior Food and Drug Administration officials are planning how to bring back to market a pill for a common bowel disorder despite new evidence that the risk of a life-threatening complication is far higher than thought when the drug was withdrawn in November, government documents show.
The FDA began reconsidering the withdrawal amid an outcry from patients who say they benefited from the prescription drug, called Lotronex. In early clinical studies, as many as 1 in 5 participants showed improvements that doctors attributed to Lotronex.
Dr. Janet Woodcock, director of the FDA's drug evaluation center, has privately voiced support for the drug to executives of GlaxoSmithKline, the manufacturer, according to the documents and people familiar with the matter. Woodcock and her aides have discussed with the company how best to orchestrate the drug's return to pharmacies--including how to structure a public advisory committee meeting so as to minimize the effect of criticism of the drug.
The flurry of activity over Lotronex once again puts a spotlight on the FDA's handling of a drug with demonstrated lethal risk and modest proven benefits. Lotronex is one of 11 prescription drugs withdrawn for safety reasons in the last four years. Eight of those drugs were approved from 1993 through 2000--an era when the FDA came under pressure from members of Congress and the White House to become more of a partner than an adversary of the $100-billion pharmaceutical industry. Aside from one antibiotic pill, none of the 11 withdrawn drugs was a proven lifesaver.
Lotronex could be returned to U.S. pharmacies as soon as this summer. It has not been sold in any other country.
During eight months on the American market last year, Lotronex was approved for use by women with diarrheal symptoms of what is known as irritable bowel syndrome. The condition can cause pronounced abdominal bloating and pain and other vexing inconveniences, such as the need to go to the bathroom on a moment's notice.
Irritable bowel syndrome, however, is not life-threatening, and Lotronex was withdrawn after being cited as the primary suspect in dozens of cases of ischemic colitis, a complication that can be lethal. It results from inadequate flow of blood to the colon. At the time of the withdrawal, voluntarily filed reports linked five deaths to the drug.
