Experts call for investigation into off-label uses of prescription medications

Medical investigators, who’ve identified 14 medications prescribed regularly for purposes other than those approved by federal drug regulators, are calling for research on so-called off-label uses to determine safety for patients.

For decades, doctors have relied on anecdotal evidence and their own knowledge of disease — beyond findings in clinical trials — to provide therapy for conditions that are difficult to treat. Following the Hippocratic edict of “first do no harm,” off-label prescribing has rescued countless people from the brink of death, and made bearable many rare disorders for which there are no approved drugs, experts say.

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But new research suggests some doctors are taking leaps of faith in risky prescribing practices that are sometimes backed by pharmaceutical companies with interests in finding new markets for established blockbuster medications. Most of the 14 drugs listed in an analysis to be published next month in the journal Pharmacotherapy are anti-psychotics and anti-depressants.

Both drug classes have come under scrutiny in recent years for unexpected side effects, even when they were being prescribed according to guidelines approved by the Food and Drug Administration.

Samuel Packer, chairman of the ethics committee at North Shore University Hospital in Manhasset, said he’s not surprised that doctors are calling for research on off-label prescribing, but he emphasized the issue is a two-headed coin because off-label prescribing can benefit some patients.

“This is a very, very complicated area, and in and of itself off-label use is not a bad thing,” Packer said.

But he said he finds it disturbing when pharmaceutical companies sponsor medical meetings and pay renowned physicians large sums of money to push specific medications for off-label uses.

Last year, widely reported research revealed psychiatrists are the most likely group of physicians to receive remuneration from drug companies and to prescribe a new class of drugs to children known as atypical anti-psychotics, which not only can be dangerous for youngsters but are unapproved for pediatric ages.

Randall Stafford and colleagues at Stanford University compiled the list of drugs most often prescribed off-label. The roster is led by Seroquel, the schizophrenia drug. Stafford said his research found Seroquel not only topped the list, it raised other concerns.

The drug costs $207 per prescription, is the subject of expensive marketing and carries a “black box” warning, the FDA’s highest level of caution for potentially harmful side effects.