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Off-Label Prescriptions Linked to Bad Reactions to Drugs

Patients taking a medication prescribed off-label are more likely to experience side effects, particularly if the off-label use is not evidence-based.
Off-Label Prescriptions Linked to Bad Reactions to Drugs

Perhaps a generally positive attitude toward taking prescription medications makes people accept drugs prescribed “off-label,” that is, treating problems for which they were not originally intended or tested. Examples would be a beta blocker for stage fright, or any antidepressant except paroxetine (Brisdelle) for easing hot flushes of menopause.

Scientists from Boston and Montreal have just published an analysis of off-label drug use in JAMA Internal Medicine. They reviewed the records of more than 46,000 primary care patients in Quebec, from 2005 through 2009 to see whether they had received off-label prescriptions.

Off-Label Drug Use Linked to More Side Effects:

They found that off-label use was 44 percent more likely to result in an adverse drug reaction [19.7 per 10,000 person-months vs 12.5 per 10,000 person-months]. The higher rate of side effects was especially clear for prescriptions in which the off-label use had little scientific evidence to justify it [21.7 per 10,000 person-months].

Most Off-Label Prescriptions Don’t Have Strong Science Behind Them:

The researchers note that 4 out of 5 off-label prescriptions lacked strong scientific evidence. Patients may want to ask whether the drug they are being offered has been approved for their condition, and if not, what research has been done to justify its use.

JAMA Internal Medicine, online Nov. 2, 2015


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About the Author
Joe Graedon is a pharmacologist who has dedicated his career to making drug information understandable to consumers. His best-selling book, The People’s Pharmacy, was published in 1976 and led to a syndicated newspaper column, syndicated public radio show and web site. In 2006, Long Island University awarded him an honorary doctorate as “one of the country's leading drug experts for the consumer.” .
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