Wednesday, January 14, 2015

Physicians, Patients Not Getting Full Information on Antipsychotic Drugs

Elements of package inserts for second-generation antipsychotic medications aimed at both physicians and patients for use in affective illness “may belie scientific data regarding the neuropsychiatric risks of these drugs,” according to Frederick Jacobsen, M.D., M.P.H., a clinical professor of psychiatry and behavioral sciences at the George Washington University School of Medicine and Health Sciences.

This oversight has significant public health implications, given the increasingly broad prescription of these drugs for mood-related disorders and for off-label uses, wrote Jacobsen in the February issue of the American Journal of Public Health. He reviewed online package inserts for 10 second-generation antipsychotics. Advertisements for the drugs also inaccurately suggest reversibility of chronic neurotoxicty, he wrote.

“Inspection of SGA package inserts ‘Patient Counseling Information’ sections … omit tardive syndromes and other long-term neuropsychiatric side effects," Jacobsen wrote. "These surprising omissions are accompanied by a shift of responsibility for identifying or monitoring long-term neurotoxicity from physician to patient: 7 of 10 SGA package inserts included ‘Medication Guides’ (for patients) that mentioned abnormal movements as potential side effects. Three of these ‘Medication Guides’ instruct patients to ‘notify the prescribing physician if such movements are noticed.’ ”

The lack of appropriate patient counseling may be tied to the brevity of clinical trials (6 to 12 weeks) used for FDA approval compared to the chronic duration of clinical use.

“Patients deserve better information and education regarding the long-term side effects,” said Jacobsen. “Long-term efficacy and safety outcomes, including side effects, of SGAs in affective illness—and in off-label uses (anxiety, sleep, children, elderly, and so on)—need to be documented in meaningful long-term trials corresponding to the realities of clinical practice.”

For more in Psychiatric News on the benefits and risks of the use antipsychotic medications, see “First- and Second-Generation Antipsychotics Compared in Federal Agency Monograph.”

--aml  (Image: Rhonda Roth/


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