Briefs of FDA actions related to medication safety and reliability (ie, boxed warnings, dear healthcare provider letters)
At FDA's request, Novartis has suspended marketing and sales of tegaserod (Zelnorm), which was approved in 2002 for the short-term treatment in women with irritable bowel syndrome whose primary symptom is constipation and in 2004 for the treatment of chronic constipation in men and women aged <65 years. New analyses of 29 clinical trials of tegaserod for a variety of gastrointestinal conditions demonstrated that tegaserod-treated patients had a statistically significantly increased risk of cardiovascular adverse events (ie, myocardial infarction, stroke, and unstable angina pectoris) compared with patients taking placebo.
At FDA's request, manufacturers of pergolide products (Permax, Valeant; generic pergolide, Par and Teva), have withdrawn their drugs from the market. This agent was originally approved in 1988 as an adjunctive therapy with levodopa for the treatment of Parkinson disease. In 2003, FDA requested that a warning regarding the risk of valvulopathy be added to the drug's label; in 2006, this warning was upgraded to a boxed warning. Two new studies have confirmed that patients taking pergolide have an increased risk of regurgitation of the mitral, tricuspid, and aortic valves of the heart.