Off-Label Use of Antipsychotic Drugs Increasing

The powerful drugs have been prescribed for a range of unapproved uses despite the risk of severe side effects.

Off-label prescription of powerful antipsychotic medications is growing increasingly common, raising serious safety concerns. According to a Washington Post article produced in collaboration with Kaiser Health News, the 11 drugs categorized as atypical antipsychotics have been prescribed to treat a range of illnesses for which they are not indicated, including sleep trouble, dementia, anxiety, attention deficit disorder, and behavioral problems in young children. The drugs can have severe side effects, including extreme weight gain, permanent facial tics, and increased risk of heart disease, type 2 diabetes, and—among the elderly—death.

Off-label atypical antipsychotic prescriptions more than doubled from 4.4 million in 1995 to 9 million in 2008, according to a study published in January 2011 in Pharmacoepidemiology and Drug Safety. Reasons for the increase include publicity around a new generation of antipsychotics, which are considered safer; hope that these drugs will work when others have failed; and direct-to-consumer advertising and increased marketing to physicians other than psychiatrists. Drug companies, which are prohibited from promoting or advertising off-label uses, have paid more than $2 billion in recent years to settle state and federal lawsuits alleging that they have illegally done so.

This increase in off-label use of antipsychotics is yet another reason for pharmacists to ensure they provide basic counseling when patients present prescriptions. It’s particularly important to ask patients if they know why they have been prescribed an atypical antipsychotic and to review possible side effects carefully.

Ms. Wick is a visiting professor at the University of Connecticut School of Pharmacy and a freelance writer from Virginia.