Lotronex is a prescription drug
first approved by the U.S. Food and Drug Administration in February 2000
to treat irritable bowel syndrome (IBS).
IBS is a chronic and painful condition marked by diarrhea, constipation
or both. There is no known cure.
Reports of serious Lotronex side effects began to build in the
weeks and months after manufacturer GlaxoSmithKline (then Glaxo Wellcome)
put the drug on the market.
By year's end, Lotronex was blamed for severe gastrointestinal
problems in 141 people -- including 96 who were hospitalized and five
People using Lotronex had problems including ischemic colitis, a
potentially fatal condition where reduced blood flow to the colon can
cause gangrene. Lotronex patients also suffered from constipation severe
enough to cause ruptured bowels.
GlaxoSmithKline agreed to pull the drug from the market in
November 2000, less than 10 months after its approval. The company sold
more than $50 million worth of Lotronex to about 300,000 people.
But after patient groups demanded that Lotronex be returned, the FDA
took an unusual and controversial step.
agency re-approved Lotronex -- though under new rules limiting the
drug's marketing and prescription.
The use of Lotronex was restricted
severe IBS whose main problem is diarrhea and who haven't found other
treatments helpful. The drug has not been shown to help men.
While 15 percent of Americans suffer from IBS, fewer than one in
20 cases is considered severe, and only a fraction of those are marked
mainly by diarrhea. Severe IBS is a disabling condition that usually
lasts more than six months. Its symptoms include frequent, severe
abdominal pain and uncontrollable urges to have a bowel movement.
GlaxoSmithKline also agreed to set up and run a program intended to
protect patients and educate them on Lotronex and its risks.
Under the program, doctors who prescribed the drug were to inform
patients about the risks, provide them with FDA-approved literature, and
have them sign an agreement that they understand the drug's risks.
Pharmacists were asked to fill only Lotronex prescriptions that carried
a sticker saying that the prescribing doctor took part in the
Critics hit the FDA decision on several grounds—saying that the
newly recommended dosage, half of the original recommendation, was not
strong enough to be effective yet was still dangerous to patients.
GlaxoSmithKline program came under fire
for being too lax to protect patients adequately. Critics said that only
bowel specialists should be allowed to prescribe the drugs, that
doctors' qualifications should be more thoroughly checked, and that
patients' side effects should be tracked.
What's more, the program is being run by the maker of the drug
itself. That's a clear conflict of interest since GlaxoSmithKline stands
to profit from Lotronex sales.
that IBS, though possibly debilitating, is not a life-threatening
condition -- while Lotronex still has potentially fatal side effects.
Others said the FDA had bowed to industry pressure to put the drug
back on the market.
The FDA could have designated
Lotronex an experimental drug, allowing it to be prescribed under
tighter restrictions but GlaxoSmithKline refused—and the FDA gave in,
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