The U.S. Food and Drug Administration allowed Lotronex on the market
after a fast-track approval process that critics say led the agency to
ignore warning signs about the drug's dangers.
journal The Lancet slams the FDA for giving in to industry and political
pressure and approving Lotronex despite known side effects.
The FDA issues a
warning to drug maker GlaxoSmithKline (then Glaxo Wellcome) saying that
Lotronex sales literature is misleading and makes unsupported claims.
May 2000: By the end of the month,130,000 Lotronex prescriptions
have been issued, and 12 serious gastrointestinal reactions reported to
the FDA. For each one the agency learns about, 10 go unreported, the FDA
As reports of serious Lotronex side effects continue to mount, the FDA
requires that a warning of the drug's risks accompany each prescription.
agrees to remove the drug from the market. The company sold more than
$50 million worth of Lotronex to about 300,000 people.
The first lawsuits
are filed against GlaxoSmithKline (then Glaxo Wellcome) by patients who
say they suffered from Lotronex side effects. A class action suit in
West Virginia charges the drug maker with failing to warn consumers
about Lotronex' risks. Others are later filed in Pennsylvania and
By year's end,
Lotronex was blamed for severe gastrointestinal problems in 141 people
-- including 96 who were hospitalized and five who died.
The FDA allows
Lotronex back on the market, though under new restrictions on marketing
and prescriptions. The safeguards are criticized as inadequate to
protect consumers from the drug's dangers.
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