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Side effects of drugs prescribed off-label often serious

Written by Diane Archer

The Supreme Court is about to consider whether drug companies should be allowed to promote their drugs for off-label use as a matter of free speech. A new study in JAMA of drugs prescribed off-label suggests that it would be a grave mistake. The researchers find serious risks from off-label use of drugs in many instances.

The research suggests that doctors who prescribe drugs off-label do so with greater care and monitor the effects on their patients. The researchers found that only 20 percent of the time that off-label drugs were prescribed was there strong evidence to support the prescription.

Data reveals that doctors often do not understand the indications for which the FDA has approved a drug’s use.  So, patients should ask their doctors about these indications before opting to take a drug prescribed for off-label use. At the very least there should be strong evidence of the drug’s efficacy for its prescribed use.

To undertake the study, the researchers looked at electronic data for more than 45,000 Canadian patients over five years, including drugs prescribed, the reason the drug was taken and treatment outcomes—all of which is not available for patients in the United States.

Of the patients studied, 7.6 percent had bad side effects. Side effects were far greater–44 percent higher–for patients taking drugs off-label than for patients taking drugs for their approved use. The researchers did not find a difference in side effects between drugs used off-label and on-label when there was strong scientific evidence to support the off-label use.

What’s clear from the study is that we need to know a lot more about prescription drug use in the United States, both on-label off-label. We currently do not capture the reasons for which drugs are being prescribed and the outcomes for patients using the drugs.  Today, it is conservatively estimated that 11.8 percent of drugs prescribed are for off-label use.

The FDA approves drugs only for particular use at a particular dosage, often based on clinical tests, checking for safety and efficacy.  Sometimes, these approvals are based on laboratory evidence, where the data is less compelling and the safety and efficacy of the drugs less clear. Either way, the FDA dedicates few resources to monitoring drugs post approval. Although drug companies generally are not allowed to market them for off-label use, doctors may prescribe drugs for any reason they choose.

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1 Comment

  • For quite a good number of drugs used in the US, it seems that off label prescribing accounts for nearly as many sales as strictly on label prescriptions.

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