Maryland Lotronex Attorneys

Lotronex was 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, but medications are being introduced to help lessen the painful effects of this condition.

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. Our Maryland Lotronex Lawyers can determine if you have a case against the manufacturer.

Have you or a loved one suffered the negative side effects of taking Lotronex? If so, contact our Maryland Lotronex Lawyers today!

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 in which 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.

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 restricted 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% of Americans suffer from IBS, fewer than one in twenty 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. Our experienced Maryland Lotronex Lawyers can help you win the compensation you deserve.