Reactions 1207 - 21 Jun 2008

FDA requests Boxed Warnings onconventional antipsychotics

The US FDA is requiring manufacturers ofconventional antipsychotics to add Boxed Warningsabout the increased risk of death in elderly patientstreated for dementia-related psychosis.1,2

The FDA says that two observational epidemiologicalstudies investigating the risk of death in elderly patientswith dementia receiving conventional antipsychoticshave been recently published.1,2 The FDA concluded,from these studies together with earlier evidence foratypical antipsychotics, that both atypical andconventional antipsychotics should be considered tohave an increased risk of death in elderly patients withdementia-related psychosis. In 2005, the FDAannounced similar labelling changes for atypicalantipsychotics.* The agency states that the warning forboth classes of antipsychotics will say that clinicalstudies indicate that both types of antipsychotics areassociated with an increased risk of death in elderlypatients treated for dementia-related psychosis.1Manufacturers of antipsychotics are being asked toupdate labelling so that all drugs have the same warninglanguage.

The FDA advises healthcare professionals that:• elderly patients with dementia-related psychosis

treated with conventional or atypical antipsychoticshave an increased risk of death

• antipsychotics are not approved for treatment ofdementia-related psychosis

• physicians who prescribe antipsychotics to elderlypatients with dementia-related psychosis shoulddiscuss the increased mortality risk with theirpatients, patients’ families and caregivers.2

* See Reactions 1047 p3; 809047599

1. FDA. FDA Requests Boxed Warnings on Older Class of Antipsychotic Drugs.Media Release : 16 Jun 2008. Available from: URL: http://www.fda.gov.

2. FDA. Information for Healthcare Professionals - Antipsychotics. Media Release: 16 Jun 2008. Available from: URL: http://www.fda.gov.

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Reactions 21 Jun 2008 No. 12070114-9954/10/1207-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved