Serious Side Effect Associated Meridia With The Anti-Obesity Drugs Fenfluramine And Dexfenfluramine

fda, Mar 16, 2005

In clinical trials, patients treated with sibutramine while on a reduced-calorie diet, showed a significant weight loss
during the first six months of treatment, and significant weight loss was maintained for one year.  In one 12-month study, the
average weight loss in patients taking sibutramine, 10 mg daily, was about 10 lbs., and in those taking 15 mg daily was about 14 lbs.  The average weight loss in persons on only a reduced calorie diet was 3.5 lbs.

 The most common side effects associated with sibutramine include dry mouth, headache, constipation and insomnia.  The drug causes a small increase in average blood pressure, and causes a higher increase in some patients.  FDA recommends patients taking sibutramine have regular blood pressure evaluations.  People with uncontrolled high blood pressure should not take sibutramine.  No cases of pulmonary hypertension, a rare but serious side effect associated with the anti-obesity drugs fenfluramine and dexfenfluramine, have been reported in clinical trials of  sibutramine.  Echocardiograms on patients taking sibutramine did not show more valvular disease than those on placebo. Sibutramine is manufactured and distributed by KnollPharmaceutical Company, Mount Olive, NJ,