Zyprexa

Zyprexa was FDA approved in the fall of 1996 for the treatment of psychosis. The Australian Adverse Drug Reactions Advisory Committee reviewed the reports of Zyprexa adverse effects and found it had received 327 suspected Zyprexa adverse reactions. The Zyprexa side effects reported included common Zyprexa effects such as weight gain and drowsiness, however particularly concerning to the medical committee were the reports of white blood cell disorders, convulsions, and neuroleptic malignant syndrome.

In 2001, British physicians that were developing schizophrenia treatment guidelines with Zyprexa and other atypical antipsychotics discovered there was no “clear evidence that they are more effective or better tolerated than older, conventional antipsychotics.” This was found after randomized controlled clinical trials. Due to conflicting drug information, the Zyprexa study authors concluded Zyprexa patients should first use conventional antipsychotics, noting that in the U.S., comparative safety and effectiveness studies between old and new drugs are not required for drug approval, which can allow approval to occur without evidence of increased effectiveness to already existent treatment options.

The British FDA equivalence warned of the Zyprexa diabetes risks after receiving 40 reports of Zyprexa hyperglycemia, diabetes, or worsening diabetes in the April 2002 Current Problems in Pharmacovigilance. The Japanese Ministry of Health, Labor, and Welfare also issued emergency safety information regarding Zyprexa and hyperglycemia resulting in diabetic ketoacidosis and coma in April 2002. After Japanese authorities received nine reports of serious Zyprexa hyperglycemia, including two deaths, the Zyprexa product labeling change was announced.

Zyprexa is the world’s best selling schizophrenia drug with a projected $4 billion in sales for all of 2003. In September 2003, the FDA finally requested the drug companies of the six atypical antipsychotic drugs, including Zyprexa include warnings on drug labels for diabetes and hyperglycemia. Zyprexa has been one of the most controversial antipsychotic drug treatments in regards to diabetes because of its well-known link to weight gain in some patients. The Zyprexa lawsuits filed claiming product-liability is not good news to Eli Lilly as Zyprexa accounts for one third of the company’s sales.

Zyprexa Study

At the American Psychiatric Association’s annual meeting held in May 2003, a study was presented finding that Zyprexa over the course of 26 weeks caused an average weight gain. Zyprexa had been experiencing growing sales until the discovery of Zyprexa weight gain, a significant finding considering the link between Zyprexa and diabetes.

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