FDA Wants Diabetes Warning on Atypical Antipsychotics

The FDA has requested that 6 drug manufacturers include labeling language about a possible link with diabetes on their antipsychotic drugs. The agency?s action follows several recent studies exploring a potential diabetes connection. Label warnings already have been required for some of the drugs overseas.

In September 2003, the FDA sent letters to Eli Lilly (maker of olanzapine), Bristol-Myers Squibb (aripiprazole), Pfizer (ziprasidone), Novartis (clozapine), Janssen (risperidone), and AstraZeneca (quetiapine). The letters recommend that patients using the socalled atypical antipsychotics be monitored for blood sugar abnormalities, especially if they have risk factors for obesity and a family history of diabetes. Although the letters said that there is no clear link between the drugs and diabetes, further study is needed. Additional label changes could be required, depending on future findings.

FDA spokeswoman Susan Cruzan said that the agency frequently makes requests for additional drug labeling. She said that she was unaware of any measures the FDA might take in case a company does not comply, which she said rarely occurs.