Zelmac: Product Market Withdrawal

[AnGe|ic]

FDA notified healthcare professionals and patients that Novartis has agreed to discontinue marketing Tegaserod Maleate, a drug used for the short-term treatment of women with inflammatory bowel syndrome with constipation and for patients younger than 65 years of age with chronic constipation. FDA analysis of safety data pooled from 29 clinical trials involving 18000 patients showed an excess number of serious cardiovascular adverse events, including angina, heart attacks, and stroke, in patients taking Tegaserod Maleate compared to patients given placebo. Patients taking Tegaserod Maleate should contact their healthcare professionals to discuss treatment alternatives and seek emergency medical care if they are experience severe chest pain, shortness of breath, sudden onset of wekness or difficulty walking or talking, or other symptoms of a heart attack or stroke. Healthcare professionals should assess their patients and transition them to other therapies as appropriate.