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Several months ago we reported about the petition
to the FDA by the consumer advocacy group Public Citizen that the Irritable
Bowel Syndrome (IBS) drug Lotronex be pulled from the market. Well, now
comes word that the drug's manufacturer has decided to volunarily pull
the drug, after sending dozens of people to the hospital and possibly
causing the deaths of at least three and possibly more users.
Glaxo Wellcome Inc. announced it was withdrawing
its drug Lotronex
under pressure from the Food and Drug Administration despite the fact
that the company maintains the medication is safe.
Lotronex was approved less than 10 months ago as
a highly effective alternative for the disabling condition and quickly
became a popular drug, with 450,000 prescriptions being
written for it since March.
Yesterday's withdrawal again raised questions about
whether the FDA is approving too many drugs too quickly. Lotronex is the
third prescription drug to be withdrawn from the market this year because
of safety concerns, and the seventh to be withdrawn in the last three
years.
"The red flag was up very
high and early on this one, and unfortunately the FDA and the company
did not pay attention," said Sidney Wolfe of the
consumer group Public Citizen,
which had petitioned recently for the removal of Lotronex.
"The FDA was bending over backwards to keep it available, when
they should have been pushing hard to get it removed."
The drug's primary complications have been severe
constipation and ischemic
colitis. Ischemic colitis is a reduction of blood flow
to the gut that can cause severe pain and bloody stools that can lead
to potentially fatal bleeding and infections.
Colitis was first identified as a side effect in
early trials of the drug, but that problem appeared at the time to go
away as soon as users stop taking the medication.
As additional cases of complications appeared after
the drug reached the market in March, the FDA in August issued a warning
to patients and doctors about the possible side effect.
After even more cases arose, the agency asked Glaxo
to significantly restrict distribution of the drug, but the company decided
to withdraw it instead.
"We have become increasingly concerned of the
risk-benefit profile of the drug, especially with serious complications
from ischemic colitis and serious constipation, and some death,"
Victor Raczkowski, of the FDA's office of drug evaluation said. He said
there had been 70 cases of ischemic colitis or severe constipation strongly
associated with Lotronex use reported as of Nov. 10, as well as the three
deaths, although the Associated Press has said that FDA documents had
linked eight deaths to the drug.
Washington Post, November
29, 2000; Page A01
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