New York Times Health
The New York Times
Home
Job Market
Real Estate
Automobiles
News
International
National
Nation Challenged
Politics
Business
Technology
Science
Health
- Aging
- Anatomy
- Children
- Fitness
- Genetics
- Men
- Nutrition
- Policy
- Psychology
- Women
- Columns
Sports
New York Region
Education
Weather
Obituaries
NYT Front Page
Corrections
Opinion
Editorials/Op-Ed
Readers' Opinions

Click Here
Features
Arts
Books
Movies
Travel
Dining & Wine
Home & Garden
Fashion & Style
New York Today
Crossword/Games
Cartoons
Magazine
Week in Review
Photos
College
Learning Network
Services
Archive
Classifieds
Theater Tickets
NYT Mobile
NYT Store
E-Cards & More
About NYTDigital
Jobs at NYTDigital
Online Media Kit
Our Advertisers
Your Profile
Your Profile
E-Mail Preferences
News Tracker
Premium Account
Site Help
Newspaper
  Home Delivery
Customer Service
Electronic Edition
Media Kit
Text Version
Tips Go to Advanced Search
Search Optionsdivide
go to Member Center Log Out
  Welcome, jdr00
E-Mail This Article Printer-Friendly Format
Most E-Mailed Articles

 

April 23, 2002

U.S. Agency May Allow the Selling of Diarrhea Drug Linked to Deaths

By DENISE GRADY

Topics

 Alerts
Food and Drug Administration
Drugs (Pharmaceuticals)
GlaxoSmithKline
Create Your Own | Manage Alerts
Take a Tour
Sign Up for Newsletters



In an unusual action, Food and Drug Administration officials will meet today to consider whether Lotronex, a drug withdrawn for safety reasons in November 2000, should be allowed back on the market with new restrictions to protect patients.

Lotronex, approved in February 2000 to treat chronic diarrhea caused by irritable bowel syndrome, was taken off the market less than 10 months later. About 275,000 people had used it, and it was linked to five deaths and serious intestinal problems in about 200 patients.

But after Lotronex was withdrawn, the food and drug agency said, it received "an unprecedented number of communications" from doctors, patients and patient advocacy groups who wanted the drug back. Many patients said they were desperate because nothing else worked for them.

Irritable bowel syndrome is not life-threatening, but some patients suffer from such severe attacks of diarrhea that they cannot leave the house. Even though Lotronex had been approved only for women, on the basis of studies that found a benefit only in women, many men had used the drug as well and wanted access to it.

Lotronex will be the first drug considered by a new food and drug agency group, the Subcommittee on Drug Safety and Risk Management, which was created in December to provide expert advice on drugs like Lotronex that pose especially complex risk-benefit questions. Lotronex was one of 11 drugs taken off the market because of adverse effects since 1997.

The session today will be a joint meeting of the new subcommittee and the food and drug agency's Gastrointestinal Drug Advisory Committee. The maker of Lotronex, GlaxoSmithKline, will present new data on the drug and a plan to market it with new safeguards. Officials will also hear presentations from the food and drug agency's scientists and from patients and advocacy groups for and against allowing the drug to be sold again.

After the presentations, the two food and drug agency groups will vote on whether the manufacturer's new marketing plan should be accepted. Their findings will then be presented to the full Food and Drug Administration, which usually follows the advice of its advisory panels.

The problem with Lotronex is that it causes an increased risk of two potentially serious conditions: severe constipation and ischemic colitis, in which circulation to the bowel is cut off. Both conditions can resolve on their own once the drug is stopped, but in some cases they can require major surgery to remove part of the intestine. Both can be fatal.

Under the company's proposed "risk management plan," Lotronex would be recommended only for women for whom other treatments had failed to control diarrhea caused by irritable bowel syndrome. Its starting dose would be cut in half, to 1 milligram a day, and the pill bottles would have information pamphlets attached. Doctors would have to request "prescribing kits" that would be delivered by company representatives who would discuss the drug.

Doctors and patients would have to sign statements saying they had reviewed the risks and knew symptoms the danger signs, including constipation, new or worsening abdominal pain, bloody diarrhea or blood in the stool. Doctors would not be allowed to prescribe more than a 30-day supply, and pharmacies would be permitted to fill only written prescriptions carrying a sticker from the prescribing kit.

"It's a pretty rigorous program, but I think people will follow it," said Ramona Dubose, a spokeswoman for GlaxoSmithKline. She said it was not clear whether doctors could continue to prescribe the drug for men as they had in the past.

Dr. Sidney Wolfe, director of a patient advocacy group in Washington, the Public Citizen Health Research Group, said, "I think it's just asking for trouble to put it back on market. Inevitably it will come off, and we will have more people with ischemic colitis and some will die."

Dr. Wolfe's group had petitioned the food and drug agency to take Lotronex off the market months before the agency did so. If Lotronex is brought back at all, Dr. Wolfe said, it should be as a tightly controlled experimental drug that could be used only with close monitoring in studies.

But some patients disagree. One, who will speak at the meeting today, is Jeffrey Roberts, who works in the brokerage industry and who has founded several self-help groups for patients. Mr. Roberts said, "We think the F.D.A. is learning that quality-of-life issues are very significant, rather than just curing an illness, and people are willing to accept some level of risk in order to have a better quality of life."



Home | Back to Health | Search | HelpBack to Top


E-Mail This Article Printer-Friendly Format
Most E-Mailed Articles


Advertiser Links

Discover New
Topics in Depth



Find More Low Fares!
Experience Orbitz!



Sale to Europe from
$199, offer ends 5/2



Reprints & Permissions Click here to order Reprints or Permissions of this Article

Search our job listings for the best opportunities or post your resume to attract top employers.


Copyright 2002 The New York Times Company | Privacy Information