CLOZARIL

CLOZARIL
Generic: Clozapine
Manufacturer: Bayer
Date Approved: April 28, 1997
Status: Black box warning April 12, 2005
Approved uses: Schizophrenia

Serious Side Effects:
Hyperglycemia
Diabetes
Heart complications
Pancreatitis
Death

Bayer manufactured Clozaril was approved by the FDA on April 28, 1997 to treat schizophrenia. The drug is only to be prescribed to those with severe forms of the disease only after alternative treatments have been ineffective. Clozaril is not approved for use by children.

The most common side effects of Clozaril include drowsiness, increased salivation, rapid heart beat, headache, lightheadedness, shaking, and dizziness. More serious side effects are fever, increased blood sugar, blood clots in the lungs, and liver disease. Since the 1980’s Clozaril has been linked with heart complications, including at least 28 deaths.

Researchers from Duke University and the FDA issued a report in the Journal of the American Medical Association (JAMA) in January of 2005 establishing the drugs link to diabetes, hyperglycemia, and pancreatitis. Furthermore, the Journal of Clinical Psychiatry reported that the FDA knew of over 140 cases of new-onset diabetes resulting from Clozaril. In recent studies reported to the FDA, there were 384 cases of diabetes linked to Clozaril, 25 of them being fatal.

Clozaril also causes the body not to produce enough white blood cells, or agranulocytosis. Therefore, anyone taking Clozaril should have regular blood tests preformed by their doctor. The drug can also lead to a dangerous nervous system condition referred to as neuroleptic malignant syndrome (NMS). Symptoms of NMS, a medical emergency, are confusion, irregular heartbeat, change in blood pressure, stiff muscles, high fever, and sweating.

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