When the drug Lotronex was withdrawn from the market in the fall of 2000, having killed five people, some patients had already hoarded a two-year supply. Patients who were so encumbered by irritable bowel syndrome that many plotted their days around access to a toilet relied on the drug to treat their condition.
Two weeks ago, they rejoiced when the Food and Drug Administration made an unprecedented reversal, ruling that Lotronex could make a comeback. It was the first time a medication that had been killed would return to the market.
But the decision to return the controversial drug to the market -- with restrictions -- may not be its final chapter. As ardently as patients have praised it, critics have cursed it. And a major medical watchdog group has indicated it might petition to have the drug banned again.
Activist patients had hounded the FDA for months after the drug was withdrawn, saying it was crucial to allowing people to live normal lives. They told of excruciating abdominal pain, of diarrhea so persistent they became shut-ins. They spoke of lives complicated by lost jobs and poor performance in school.
"Within three days after taking Lotronex all of my symptoms disappeared," said Jeffrey Roberts, recalling when he first took the drug two years ago. Without it, Roberts, who lives in Toronto, was hampered getting to work at a brokerage firm because of frequent diarrhea.
Lotronex's second chance came with an FDA statement saying it believes "the benefits outweigh the possible risks in women with severe diarrhea-predominant irritable bowel syndrome who have exhausted all available therapeutic alternatives." The drug's return will carry restrictions: In addition to being prescribed only to women whose syndrome is both severe and chronic, doctors are required to enroll in a "prescribing program," certifying they are qualified to diagnose the disease and understand the risks of the medication.
Irritable bowel syndrome also can be typified by severe constipation, and sometimes patients fluctuate between the two. An estimated 25 million people in the United States, most of them women, have the syndrome. The FDA says clinical data has not shown the drug can help men.
Roberts heads a support group, the Irritable Bowel Syndrome Self Help Group, and said some members had managed to stockpile hundreds of pills.
But documents submitted to the FDA during the past two years tell a story of devastation and even death.
Five people, according to records from the drug's maker, GlaxoSmithKline, died as a result of taking it.
Eighty-five people developed ischemic colitis, an inflammation of the colon that occurs when blood flow is interrupted. Another 113 developed constipation so severe it required hospitalization. Thirty-four of those had to undergo surgery to remove portions of their colons.
Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, said Lotronex had helped turn a non-life-threatening condition into a deadly affliction. He was angered by the FDA's June 7 re-approval of the drug, a medication his group had fought vigorously to outlaw.
Wolfe says people who could have dealt with irritable bowel syndrome by changing their diet died because they chose Lotronex instead.
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