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FDA and Pfizer Link Geodon to Diabetes

Aug 31, 2004 | AP

The Food and Drug Administration and pharmaceutical giant Pfizer Inc. warned doctors that the company's antipsychotic drug Geodon has been linked to extremely high blood sugar and diabetes.

Pfizer's letter to doctors, announced on Tuesday, follows a September 2003 FDA request that manufacturers of the six most widely used antipsychotic drugs revise labels to reflect additional risks.

The remaining drugs affected by the FDA request include Eli Lilly's Zyprexa, Bristol-Myers Squibb's Abilify, Novartis' Clozaril, Janssen's Risperdal and AstraZeneca's Seroquel.

Pfizer's warning letter to doctors said "few reports" of hyperglycemia or diabetes were noted in patients prescribed Geodon. But it also noted fewer patients were treated with that particular antipsychotic.

As a whole, so-called atypical antipsychotic drugs were linked to such adverse events as diabetes and high blood sugar in some cases, extreme enough to induce coma or death.

Geodon, approved to treat schizophrenia, on Aug. 23 gained FDA approval for the treatment of acute bipolar mania.

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