FDA Warns of Health Risks with Off-label Antipsychotics

Newly discovered health risks forseniors taking certain "atypical antipsychoticdrugs" for off-label indicationshave prompted the FDA to alertpharmacists and other health careproviders to the problem.

The drugs-which include aripiprazole,olanzapine, clozapine, risperidone,and ziprasidone-are approvedfor the treatment of schizophrenia andmania. FDA officials, however, saidthat new research suggests that, whenthese products are prescribed off-labelto treat behavioral disorders in elderlypatients with dementia, a higher risk ofdeath may result. Agency officials haveraised the same concerns about a combinationolanzapine and fluoxetineHCl formulation (Symbyax), a drugapproved for the treatment of bipolardisorder.

In addition to alerting pharmaciststo these problems, FDA officials haveasked the manufacturers to place newboxed warnings on their drug labeling.The officials also are urging patientswho have been taking the drugs fordementia or other off-label behavioralsymptoms to have their therapyreviewed.

Mr. Rankin is a freelance medical writer.