Clozaril

Clozaril was FDA approved in 1989 for the treatment of schizophrenia in patients that are not responding to other therapies. Since then, Clozaril has been linked to many life-threatening, serious adverse effects. Clozaril side effects have been a concern for years, and Public Citizen consumer group has written many letters regarding the safety of Clozaril antipsychotic drug.

Immediately after Clozaril was approved, Australian doctors writing in The Lancet reported 23 cases of myocarditis and cardiomyopathy in Clozaril patients, six of who died. Reports linking Clozaril to heart disorders were being made in the mid-1980s, however myocarditis and cardiomyopathy were not included on Clozaril side effect product labeling until March 2002.

The Public Citizen consumer group brought attention to the fact that since marketing began in 1999 for Clozaril, reports showed that patient conditions were worsening instead of becoming improved. The consumer advocacy group has discovered approval of generic versions of existent pharmaceuticals instead becomes replaced with a lesser quality product.

In 2002, the FDA approved Clozaril for a new use in schizophrenia but warned that Clozaril patients are at risk for a life-threatening blood disorder called agranulocytosis and must have frequent blood tests as a result. The Clozaril tests are required so that the blood disorder can be found at an early enough stage to treat it immediately. The agency also warned of seizures as a Clozaril side effect.

Public Citizen also noted in July 2002 that the group was becoming increasing worried about reports of elevated blood sugar levels and diabetes with Clozaril and other atypical antipsychotics. Back in the November 28, 2001 Journal of the American Medical Association issue, medical officers from the FDA and a Duke University Medical Center first reported on a possible link between Clozaril and hyperglycemia.

In September 2003, the FDA requested the makers of six widely used class of antipsychotic drugs to include labeling language changes warning of the possible link between the antipsychotics (Clozaril, Geodon, Zyprexa, Risperdal, Seroquel, and Abilify) and diabetes. Clozaril, part of the highly prescribed atypical antipsychotics, had been shown in studies to have a higher incidence of low blood sugar and diabetes among patients. For Clozaril patients, this FDA announcement was not very concerning.

Earlier in September, statistics reported Clozaril antipsychotic drug had attracted high numbers of adverse reactions, noting that Clozaril and other antipsychotic drugs has been the subject of controversy as well as focus for lawsuits filed. Clozaril and the other five leading antipsychotic drugs have been extremely financially successful, totaling U.S. sales at $5.4 billion in the 12-month period that ended August 31, 2003.

Already linked to Tardive Dyskinesia, a movement disorder that is potentially irreversible, Clozaril patients’ risk of suffering serious Clozaril side effects appear to become greater the longer Clozaril treatment exists. There is yet to be a Clozaril Tardive Dyskinesia treatment, though some Clozaril patients that have developed the syndrome will experience relief if Clozaril discontinuation is a consideration. A better understanding on signs and symptoms of Clozaril side effects should be stressed, especially since adverse effects like Tardive Dyskinesia may not be caught during early stages because antipsychotic drugs can sometimes mask the signs of Tardive Dyskinesia.