tegaserod, Zelnorm (cont.)

PREGNANCY: No ill effects were seen in the fetuses of pregnant rats given 15 times the human dose and rabbits given 50 times the human dose of tegaserod (on a per-weight basis). Nevertheless, there are no adequate studies of tegaserod in pregnant women. Therefore, physicians must weight the potential benefit of giving tegaserod during pregnancy against the unknown risk.

NURSING MOTHERS: Tegaserod is secreted into the breast milk of nursing rats. Very high doses of tegaserod in mice cause tumors. Due to the demonstration of these tumors and the lack of safety data in children, physicians must weigh the potential benefit of giving tegaserod to nursing women against the unknown risk to the infant.

SIDE EFFECTS: Tegaserod is well tolerated in most patients. The most commonly reported side effects are headache (1 in 6 patients), abdominal pain (1 in 8), and diarrhea (1 in 11). Only diarrhea has been reported substantially more frequently than with placebo treatment (sugar pill). Rarely the diarrhea is severe, leading to hospitalization for dehydration and requiring intravenous fluids. Ischemic colitis has been seen rarely in patients taking tegaserod although it is not clear if there is a causal relationship. Patients who develop signs of ischemic colitis--worsening abdominal pain, bloody diarrhea--should stop taking tegaserod and contact their physicians.

Following release of tegaserod, a safety analysis showed an excess number of serious cardiovascular adverse events, including angina, heart attacks, and stroke, in patients taking tegaserod compared to patients taking placebo. Therefore, patients should seek emergency medical care if they experience severe chest pain, shortness of breath, sudden onset of weakness or difficulty walking or talking, or other symptoms of a heart attack or stroke.

Reference: FDA Prescribing Information

Last Editorial Review: 4/21/2008

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