Pharmaceutical Business review

Novartis’ Clozaril has serious health consequences, researchers say

Metabolic syndrome is a group of conditions that increase the risk for heart disease, stroke and diabetes. The conditions include high blood pressure, excess body fat around the waist, abnormal levels of cholesterol and triglycerides and insulin resistance.

More than half the studied patients taking clozapine (marketed as Clozaril by Novartis) had metabolic syndrome, while only about 20% of those in a comparison group did, the researchers report. Patients with metabolic syndrome in this study would be expected to have a two-to-threefold increase in cardiovascular disease mortality.

Many studies have shown that clozapine is associated with weight gain, but this is the first study to describe clozapine’s link to metabolic syndrome.

“Clozapine is the last hope for many people,” said Dr J Steven Lamberti, associate professor of psychiatry at the University of Rochester. “But there are long-term health implications. This study suggests that patients who need the most effective medication are between a rock and a hard place.”

In addition to its superior efficacy for patients resistant to conventional antipsychotic drugs, clozapine also is the only medication currently approved by the FDA for the treatment of suicidal behavior. Considering this, the increased physical health risks must be balanced with the potential benefits of clozapine, the researchers conclude.

They suggest that physicians should monitor closely people who receive clozapine with regular tests for glucose and blood lipid levels, blood pressure and body weight.