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Controversial Drug Lotronex to Make Comeback

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By Delthia Ricks
Staff Writer

When the drug Lotronex was withdrawn from the market in the fall of 2000, having killed five people, some patients had already hoarded a two-year supply.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 were so encumbered by irritable bowel syndrome that many plotted their days around access to a toilet.

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 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Activist patients had hounded the FDA for months after the drug was withdrawn, saying it was crucial to allowing people to live normal lives.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 obtained a prescription two years ago as an "off-label” use, the term used when doctors prescribe an approved medication outside its guidelines. He 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. Two with severe constipation died; one of them had Alzheimer's disease and was unable to report her constipation and pain to caretakers.

Lotronex had been on the market for only nine months, after its approval in February 2000.

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.

His Washington, D.C.-based watchdog group, part of Ralph Nader's nonprofit consumer action organization, has targeted five other prescription medications, most recently targeting the diet drug Meridia, which was approved in 1997. The medication has been linked to 19 deaths in this country and four in Europe.

Serious complications showed up shortly after Lotronex was first approved, Wolfe said.

"It was a serious mistake for the drug ever to be approved,” he said. And its re-introduction "could prove to be problematic again.” Wolfe said he may consider efforts to have Lotronex banned again.

GlaxoSmithKline voluntarily withdrew Lotronex in November 2000 as reports of problems were growing. A spokeswoman for the company last week said sales will resume after production starts again in a few months.

Lotronex was the only drug ever approved for irritable bowel syndrome, and it was advertised widely in medical journals. Shortly after its approval, more than 270,000 patients were receiving prescriptions.

Some critics find a flaw in the FDA's allowing GlaxoSmithKline to oversee the prescribing program.

Larry D. Sasich, also of Public Citizen's Health Research Group, likens it to a "wolf guarding the henhouse.”

But some doctors who treat people with irritable bowel syndrome disagree.

"This is a good drug,” said Dr. Lucy Harris, an expert in the treatment of the condition at New York Weill Cornell Center in Manhattan. Harris plans to prescribe the medication under the new guidelines.

She said she believes the new vigilance will provide desperate patients a means of controlling their disorder. "Prior to this,” she said of Lotronex, "there were no drugs for these patients.”

An advocate for people with the syndrome, Harris said she believes the drug became a killer because some doctors didn't know how to prescribe it.

Patients with the diarrhea-predominant form of the disease fared well on the drug, she said.

Lotronex works, doctors say, by acting on the serotonin receptors in the colon, aiding in the normal function of the intestinal tract. It "stimulates the gut to move and secrete various fluids,” Harris said.

But, she added, it also slows the intestinal tract. A slower tract means more blockage for those whose condition is constipation-dominant.

"For my patients, this drug has meant freedom,” she said. "It opened the door to a whole new life. One woman told me she could now go places without knowing the location of every toilet in New York City.”

Harris, who has served as a paid consultant to GlaxoSmithKline on the nature of irritable bowel syndrome and its treatment, said she would like to see Lotronex undergo a new round of clinical trials.

Another drug that is also a serotonin-antagonist, but produced by a different pharmaceutical company, is in clinical trials, she said.

Wolfe, meanwhile, said Lotronex did not perform well enough in clinical testing the first time around and was shown to be not much better than placebos.

"You would think that if these patients needed a medication so desperately, someone would have come up with one that worked better than a placebo,” Wolfe said.

"Certainly this is not a good precedent,” Wolfe said of the FDA's reversal. The agency has said the drug's return is not a prelude to re-approval of other banned medications.

In 1997, the FDA voted to approve thalidomide for treatment of skin problems associated with leprosy. It had caused a horrific spate of birth defects in the 1950s and early 1960s. But thalidomide had never been approved in the United States. It had been prescribed mostly in Canada and Europe as a sedative for morning sickness in pregnant women. Some babies of those mothers were born with stunted, fin-like extremities.

Doctors have prescribed it "off-label” to patients with a variety of cancers because it boosts the immune system and blunts the growth of cancer-related blood vessels.

Copyright © 2002, Newsday, Inc.

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