Clozaril / Clozapine

Modified on 2009/10/14 21:41 by admin
Updated September 2007- Clozapine is an antipsychotic drug used to treat only those patients who have failed to respond to alternative treatment. Clozapine is the generic version of Novartis AG's brand name drug Clozaril. Users of Clozapine must undergo frequent blood tests and participate closely with their healthcare professional. Zenith-Goldline Pharmaceuticals, Inc. manufactures Clozapine.

There has been speculation that Zenith-Goldline's Clozapine does not work in the same manner, or as well as, Novartis' Clozaril. According to the Food and Drug Administration (FDA), the agency is monitoring the situation and will issue a statement should such rumors be confirmed.

In February 2001 the FDA and Novartis strengthened the boxed warning and warnings sections of the prescribing information (PI) for Clozaril as follows: (1) The previously existing boxed warning has been relocated to the beginning of the PI and revised to advise health care providers of the association of myocarditis with clozapine therapy; (2) A subsection has been added to the warnings section entitled "Myocarditis" to provide data and clozapine treatment guidelines related to this issue.

Clozaril has been linked to diabetes. A recent study found that 384 diabetes cases, 25 fatal, have been reported to the FDA by Clozaril users. In August 2003, researchers with the Department of Veterans Affairs, Boston University and the University of Illinois at Chicago released findings from a study conducted on three antipsychotic medications, including clozapine, that also linked the drug to an increased rate of diabetes.

Clozaril and tardive dyskinesia have also been linked.

A report published in the August 2003 issue of the medical journal Pharmacotherapy linked Clozaril use to the development of pancreatitis.

In April 2004, FDA and Novartis notified healthcare professionals of revision to the WARNINGS section of Clozaril labeling, describing the increased risk of hyperglycemia and diabetes in patients taking Clozaril. FDA has asked all manufacturers of atypical antipsychotic medications, including Novartis, to add this Warning statement to labeling. In 2007, the Institute for Safe Medication Practices and the Division of Public Health Sciences, Wake Forest University School of Medicine, conducted a longitudinal Adverse Events Reporting System Review of the U.S. FDA's most dangerous drugs. The study found clozapine to be the third most dangerous drug on the market with the third highest number of suspect drug deaths.  Over the eight years of the study, clozapine was a lethal drug on the market accounting for more than 3,200 deaths in an 8-year period. Clozapine was also rated the twelfth most serious drug for serious outcomes requiring  medical treatment or resulting in disability.  According to FDA reports there were over 4,300 adverse event reports of serious drug events involving Clozaril in an eight year period.

See your doctor if you have experienced serious health problems after taking Clozaril or Clozapine. In addition, it may be important to contact an attorney who can help you protect your legal rights. Please keep in mind that there may be time limits within which you must commence suit.

See Also

  1. Antidepressants & Other Psychiatric Drugs
  2. Diabetes
  3. Myocarditis: Overview
  4. Pancreatitis: Overview
  5. Tachycardia / Fast Heartbeat: Overview
  6. Tardive Dyskinesia
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