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The drug Lotronex (alosetron hydrochloride) should
be pulled from the U.S. market because of its risk of serious side effects,
the consumer group Public Citizen
has said in a petition to the Food and Drug Administration (FDA). The
group, founded by current Green Party Presidential candidate Ralph Nader,
is asking the FDA to immediately withdraw Lotronex, a prescription drug
approved last February for treating women with one type of irritable bowel
syndrome (IBS).
Last week, the FDA strengthened warnings about Lotronex
in response to 19 so far linking the drug to serious side effects. This
makes it the be the first drug required to carry a consumer-friendly guide
with every bottle to explain possible risks. The agency also toughened
the cautions written for doctors.
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Public
Citizen disagreed with the FDA's new warning labels, saying in
its petition that Lotronex offered only "limited" relief
while exposing patients to possibly life-threatening adverse effects.
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The group said its review of FDA documents showed
that up to that point Lotronex had been associated with at least 26
cases of ischemic colitis, a serious condition that restricts blood
flow to the colon.
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The FDA has also linked Lotronex to rare cases
of severe constipation.
Public Citizen said it did not think those measures
were enough to prevent further harm, or even death, from Lotronex. "You
will have best protected patients when you assure that this drug is banned,"
the group said to the FDA.
Irritable bowel syndrome afflicts an estimated 25
million Americans, most of them women, with frequent diarrhoea, constipation
or both.
An FDA official said the agency will review Public
Citizen's comments. "We will carefully consider the petition,"
the official said.
Public
Citizen's Health Research Group
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