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What is Lotronex


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 who died.

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.



In June 2002, the agency re-approved Lotronex -- though under new rules limiting the drug's marketing and prescription.

The use of Lotronex was restric
ted to women with 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 GlaxoSmithKline program.

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.


The 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.

Some poin
ted out 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 designa
ted Lotronex an experimental drug, allowing it to be prescribed under tighter restrictions but GlaxoSmithKline refused—and the FDA gave in, critics said.


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