FDA Approves Tegaserod Reintroduction for IBS with Constipation


Originally approved in 2002, tegaserod (Zelnorm) was withdrawn in 2007 due to potential safety concerns.


The US Food and Drug Administration (FDA) has approved the reintroduction of tegaserod (Zelnorm) for the treatment of irritable bowel syndrome with constipation (IBS-C) in women under 65 years of age.

Tegaserod was initially approved by the FDA in 2002 for the treatment of irritable bowel syndrome with constipation in women. The drug was voluntarily removed from the market in the US in 2007 in reaction to a safety concern.

"We are excited about what the reintroduction of Zelnorm means for patients suffering from irritable bowel syndrome with constipation. We have continually heard from patients and clinicians alike that the IBS-C community is eager to have Zelnorm return to the US as an available treatment option," said P. Breckinridge Jones, CEO of US WorldMeds.

The FDA’s decision to approve tegaserod was supported by data from 29 placebo-controlled clinical trials as well as treatment outcome data. The FDA convened a Gastrointestinal Drugs Advisory Committee (GIDAC) during the tegaserod review process. The Advisory Committee voted 11 to 1 in support of approving tegaserod for reintroduction.

Tegaserod is an oral treatment taken twice per day that should be taken at least half an hour before meals. It targets the 5-HT4 receptor at many neurons and smooth muscle cells in the gastrointestinal tract, inducing contraction and relaxation, and reducing pain. The

The tegaserod label warns against use in patients with a history of heart attack, stroke, transient ischemic attack, angina, ischemic colitis, intestinal blockage, gallbladder problems that caused symptoms, scar tissue that formed between the tissues and other organs in the abdomen, severe kidney problems, end-stage kidney disease, or moderate-to-sever liver problems.

The most common side effects listed are headache, abdominal pain, nausea, diarrhea, flatulence, dyspepsia, and dizziness.

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