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Fears cause low sales of Lotronex
      05/10/04 01:46 PM
HeatherAdministrator

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Glaxo seeks fewer barriers to Lotronex

By Lisa Richwine

ROCKVILLE, Md., May 5 (Reuters) - Limits put in place to minimize potentially deadly risks from an irritable bowel drug may be discouraging too many seriously ill patients from using it, maker GlaxoSmithKline Plc <GSK.L> said on Wednesday.

Glaxo pulled Lotronex off the market in November 2000, eight months after its debut, because of dozens of reports of users suffering severe constipation or ischemic colitis, inflammation of the large bowel caused by reduced blood flow. At least five patients died from those complications.

The medicine was re-introduced in November 2002, with restrictions, in order to provide access to patients with severe forms of the disease and few options.

Doctors are encouraged to report side effects and sign a form saying they have told a patient about risks. Patients also are asked to sign a consent form.

The program may have frightened away some patients and burdened doctors, said Craig Metz, GlaxoSmithKline vice president for U.S. regulatory affairs.

"We are going to look for ways to make this less onerous" while maintaining safeguards, Metz told a Food and Drug Administration advisory committee.

About 10,000 patients, a far lower number than expected, received at least one Lotronex prescription from November 2002 through December 2003, Metz said. Only between 10 percent and 20 percent of patients got refills.

At least 111,000 patients may have severe cases of irritable bowel syndrome and could benefit from the drug, GSK officials said.

Some FDA panel members said the program was working by discouraging many patients from using the medicine.

"That is what the point is," said Robyn Shapiro, professor of bioethics at the Medical College of Wisconsin.

The FDA believes the risk reduction program has been successful but will work with the manufacturer to identify overly restrictive barriers to drug access, said Dr. Robert Justice, head of the FDA's gastrointestinal drugs division.

No drug-related deaths were reported between November 2002 and February 2004, GlaxoSmithKline said. Eight cases of ischemic colitis, a potentially fatal reduction of blood flow to the colon, were recorded, as well as 5 cases of severe complications from constipation.

Consumer watchdog Dr. Sidney Wolfe said the restrictions had failed to adequately protect patients. He said the drug should once again be withdrawn, and a tightly controlled research program set up for seriously ill patients, he said.

GlaxoSmithKline has said it does not expect Lotronex to significantly impact the giant London-based drug maker's finances.

Irritable bowel syndrome, or IBS, causes alternating bouts of constipation and diarrhea as well as abdominal pain and sometimes incontinence. Severe cases can be debilitating.

Lotronex is the only prescription drug approved for treating women with IBS whose main symptom is diarrhea.

Copyright 2004, Reuters News Service

http://www.forbes.com/business/healthcare/newswire/2004/05/05/rtr1360714.html

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