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New Concerns Raised Over Dangers of Off-Label Drug Use

off-label drug use subject to new scrutinyFew topics in healthcare are as contentious as that of off-label drug use. And now, a new study published in the Journal of the American Medical Association’s Internal Medicine edition adds new fuel to the fire.

Off-label drug use is nothing new. Based on the pretense that a prescription drug could be useful in circumstances other than the specific uses approved by the US Food and Drug Administration, doctors may use their discretion to prescribe the drug for the treatment of other symptoms.

Marketing these off-label uses has been illegal for quite some time. However, pharmaceutical companies are fighting back; and winning. One such corporation, Amarin Pharmaceuticals, successfully used the First Amendment to argue that its (the corporation’s) right to free speech was being violated by its inability to market the off-label “benefits” of its drugs directly to doctors. This “victory” comes just over a year after Endo Health Solutions was ordered to pay $193 million in fines for the off-label promotion of its pain-reduction drug Lidoderm.

The study published in JAMA sheds new light on and helps to quantify just how much off-label drug use is actually going on. In so doing, it has also provided key insights into the impact of the practice on patients.

The records of 46,000 Canadian adults were examined for their 151,000 prescriptions. Of those 151,000 prescriptions, more than 10% were written for off-label use. 80% of those off-label prescriptions were written despite a lack of strong scientific evidence supporting the use of the drug for the patient’s particular condition.

3,484 adverse effects from these off-label prescriptions were recorded at an estimated cost of between $759 and $1,214 per incident.

But, in the end, just how widespread is this problem? Well, to look at prescription numbers for quinine, for example, one would have to assume that malaria is running rampant throughout the industrialized world. However, quinine is also used, off-label, to treat leg cramps and restless leg syndrome.

The result?

99.4% of the prescriptions written for quinine are not written to treat malaria; the only “approved” use. And, quinine isn’t even the drug most often prescribed for off label use.

While the Canadian study is a great step toward gaining accurate information, far more work must be done to quantify the effects of off-label drug use before regulations are loosened any further. And, doctors at the Veterans Affairs Pittsburgh Healthcare System agree. They’ve written that the Canadian study provides “compelling evidence” of issues that require further examination by both the US FDA and the court system.

Isn’t the potential to save lives worth a little additional scrutiny by those entrusted with the public good?