الأربعاء, 23 أيار 2012 2. رجب 1433
The FDA notified doctors on
Thursday of an increased risk of heart attack and
stroke in patients with a history of cardiovascular disease taking
Abbott’s obesity drug Meridia (sibutramine)
The label for Meridia already includes warnings against using it in patients with cardiovascular disease, but the
agency said that Abbott agreed to add a stronger warning that explicitly states the drug should not be used in people with a history of cardiovascular disease. The update will note that it should not be used by patients
with heart failure, hypertension, arrhythmias and other cardiovascular problems.
The agency issued an early communication notice in November, after preliminary results from the SCOUT study
showed that 11.4 percent of patients in the trial receiving Meridia experienced a cardiovascular event,
compared with 10 percent taking placebo. The trial enrolled around 10 000 patients with a history of
cardiovascular disease or type 2 diabetes with one additional cardiovascular risk factor.
Separately, the European Medicine Agency's Committee for Medicinal Products for Human Use (CHMP)
announced Thursday that it recommended suspending sales of weight-loss drugs containing sibutramine
due to concerns about an increased risk of cardiovascular events, compared with placebo.