|
Bowel
Drug Should Stay Off Market
WASHINGTON
(Reuters) - A US consumer group on Wednesday urged regulators
to resist pressure to put the irritable bowel treatment Lotronex
back on the market, saying new data reinforced the drug's dangers.
Public Citizen
said reports to the Food and Drug Administration (FDA) showed
141 cases of severe intestinal problems among patients who took
Lotronex.
That figure
is nearly twice the number of reports that were on hand in early
November, shortly before the drug was withdrawn, the group said,
adding that there have been five deaths ``related to adverse gastrointestinal
reactions in people using Lotronex.''
The FDA had
asked for Lotronex's withdrawal, citing three deaths as possibly
linked to the drug when it was pulled November 28. But industry
and patient groups are pressing the agency to reconsider, and
FDA officials are weighing whether to allow the prescription medication
to be sold again, according to Public Citizen.
When Glaxo
Wellcome, now part of GlaxoSmithKline Plc , pulled Lotronex, company
officials said they did not agree with the FDA's analysis of the
drug's safety and thought side effects could be managed.
Officials
at the company and the FDA were not immediately available for
comment on Wednesday.
Irritable
bowel syndrome afflicts millions of Americans, mostly women, and
treatments are limited. The disorder can cause disabling bouts
of constipation, diarrhea, abdominal pain and bloating.
Lotronex had
been approved in February 2000 to treat women whose main irritable
bowel symptom is diarrhea. About 500,000 prescriptions were written.
But reports
soon surfaced of Lotronex patients experiencing severe constipation
and ischemic colitis, a condition that restricts blood flow to
the colon and can cause severe damage.
Through the
end of 2000, 63 Lotronex patients had ischemic colitis and 75
had severe constipation, Public Citizen said, adding that most
of those people had to be hospitalized.
In an FDA
memo obtained by Public Citizen, agency reviewers concluded ``there
are no known risk factors to predict'' when those problems might
occur.
Given that
danger, the FDA should allow Lotronex only for experimental use
in a closely watched setting, if at all, Public Citizen said.
``If anything
other than this approach is used, the toll of needless deaths
and serious injuries, and the repeat ban that will inevitably
occur, will be on the hands of those FDA officials responsible,''
the group wrote in a letter to the FDA.
Reference
Source 89
For more information on how to prevent other diseases, use
PreventDisease.com's "Quick
Prevention Resources".
|
