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After 50 adverse events (primarily tachycardia, hypertension and arrhythmias) plus 2 deaths from cardiovascular causes were reported, Sibutramine (Meridia) has been taken off the market in Italy. In the United States, nineteen of the deaths were from cardiovascular causes: 10 people under 50 years of age, and 3 women under 30. Canada reports 28 adverse events (with no deaths) in patients using sibutramine between December 2000 and February 2002. Most of these adverse events were hypertension, arrhythmias and tachycardia.
Meridia enhances satiety, acting centrally as an inhibitor of both norepinephrine and serotonin reuptake. It is assumed to act peripherally, increasing metabolic rate, thermogenesis and energy expenditures by stimulating the sympathetic nervous system. Sibutramine minimally slows down the reuptake of dopamine but has no recognized effect on acetylcholinergic or histaminergic systems. Sibutramine is indicated as a support to nonmedical interventions such as diet to promote weight loss and weight maintenance in patients with an initial body mass index (BMI) of 30 kg/m2 or higher or in those with a BMI of 27 kg/m2 or higher in the presence of other cardiovascular risk factors.
Increases in blood pressure and heart rate are known to occur with the use of Meridia. Serious adverse events, although infrequent, include seizures, gallstones (due to rapid weight loss), glaucoma and manic episodes in bipolar patients. Common but less severe effects include dry mouth, headache, insomnia and constipation. Meridia does not appear to cause cardiac valve disease, maybe because it does not cause serotonin release. It is not yet known whether Sibutramine may be related with primary pulmonary hypertension.
The benefits (reduced risks of obesity, improvements in glycemic control, hyperlipidemia) and the risks (especially cardiovascular adverse effects) of sibutramine therapy must be discussed with patients together with alternative and complementary measures such as diet, exercise and lifestyle modification.