Few Patients Aware When They’re Getting Drugs Off-Label

Most patients don’t know when they are receiving drugs for off-label uses, or uses for which a drug has not received U.S. Food & Drug Administration (FDA) approval.

“Since the U.S. Food and Drug Administration does not regulate the practice of medicine, off-label drug use has become very common,” study lead author Dr. Christopher Wittich, an internal medicine physician at the Mayo Clinic in Rochester, Minnesota, said in a clinic news release, wrote HealthDay News. “Health care providers and patients should educate themselves about off-label drugs to weigh the risks and benefits before a physician prescribes one or a patient takes one,” he added.

The term “off-label” regarding drug use, means that the medication has been prescribed with a dosage, a form of a dosage, or a purpose for which it is not approved, explained researchers in a report published online, August 6, in the Mayo Clinic Proceedings.

A 2006 report found that, in the most common medications, about 25 percent or one in five, prescriptions were written off-label, according to the researchers. As an example, said HealthDay News, some antidepressants are considered a primary treatment for neuropathic pain, which is not an FDA-approved use. Morphine, many inhaled bronchodilators, antimicrobials, anticonvulsants, and proton pump inhibitors (PPIs) are also prescribed for children despite not being FDA-approved for the pediatric demographic, HealthDay News noted.

Prior research has revealed that 79 percent of children were taking at least one off-label medication upon discharge from a children’s hospital, the study authors pointed out in the release, said HealthDay News.

Although drug makers are prohibited from promoting their drugs for off-label uses—and, if they do, they are subject to very heavy fines—physicians can prescribe medications for any reason they deem appropriate, said HealthDay News. Not only are doctors not mandated to advise patients if they are prescribing a medication off-label, they are also not liable for off-label drug usage, the researchers pointed out.

HealthDay News noted that GlaxoSmithKline recently agreed to pay a record $3 billion to settle a case concerning allegations of off-label drug-use marketing. Merck Sharp & Dohme was fined $322 million over allegations it promoted the painkiller, Vioxx, off-label.

We also recently wrote that a California hospital is facing scrutiny over the way patients at the facility were treated with two controversial bone growth products, Stryker’s OP-1 Putty and Medtronic Inc.’s Infuse Bone Graft. According to a report from Mass Device.com, the California Department of Public Health launched an investigation of Pomona Valley Hospital after a patient filed suit alleging she suffered serious injuries after receiving Stryker OP-1 Putty and Medtronic Infuse in off-label procedures without her consent.

This isn’t the first time Stryker and Medtronic have been accused of illegally promoting their bone growth products. According to Mass Device, Stryker pled guilty to a misdemeanor earlier this year and agreed to pay $15 million to settle federal charges that it illegally promoted off-label use of the OP-1 Putty. The U.S. Justice Department recently closed a similar investigation of Medtronic Infuse without bringing any charges.

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