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Old 13th July 2009, 03:09 PM
Pharma Newshound Pharma Newshound is offline
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Default Schizophrenia Drug Limits May Have Led to Deaths

Source: Bloomberg.com

By Carey Sargent

Restrictions on the use of the antipsychotic medicine clozapine may have led to thousands of additional deaths in schizophrenia patients around the world, a study published in The Lancet medical journal found.

Researchers examined data from patients taking the six most frequently used antipsychotic drugs and found that clozapine was associated with the lowest death rate compared with use of the older medicine perphenazine. Clozapine was linked to a 26 percent reduction in mortality according to the study, led by Jari Tiihonen at the University of Kuopio in Finland.

Doctors can prescribe clozapine, first developed by Switzerland’s Novartis AG, only after two unsuccessful trials with other antipsychotics because it has been linked with agranulocytosis, a condition causing a severe decrease in white blood cells and problems such as fevers, fatigue and bleeding sores, Tiihonen said. Patients taking clozapine need weekly blood monitoring for six months followed by monthly testing to look for signs of the disorder, he said.

“Our results raise the issue of whether clozapine should be used as a first-line treatment, because it seems to be the safest antipsychotic in terms of mortality and it is also the most effective,” Tiihonen and colleagues wrote in the study. “However, clozapine is inexpensive, and hence it’s unprofitable for the pharmaceutical industry to market compared with other second-generation antipsychotic drugs.”

First Approved

Clozapine was the first approved drug in the class known as atypical antipsychotic medications, which also includes AstraZeneca Plc’s Seroquel, Johnson & Johnson’s Risperdal and Eli Lilly & Co.’s Zyprexa.

In the study, Seroquel was associated with a 41 percent increase in mortality compared with patients taking the older medicine, while Risperdal was associated with a 34 percent increase. The older, generic medicine haloperidol was linked to a 37 percent increase in mortality.

The difference in mortality between clozapine and the other antipsychotic drugs may be attributable to more intensive monitoring during treatment, greater effectiveness, lower safety of other drugs, or all of these factors, the researchers said.

The use of antipsychotics in general is associated with a 20 percent reduction in mortality, the study found. The Ministry of Health and Welfare in Finland funded the research.

To contact the reporter on this story: Carey Sargent in Washington at csargent3@bloomberg.net
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