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FDA And Pfizer Link Geodon To Diabetes FDA And Pfizer Link Geodon To Diabetes -- Posted by Gumbo on 11-01-04 17:25
FDA And Pfizer Link Geodon To Diabetes
September 1, 2004
WASHINGTON (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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