Patients in the Dark about Off Label Prescription Writing

A new report published in the Mayo Clinic Proceedings has revealed that most patients are unaware when their doctor prescribes them off-label drugs to treat their medical condition. Off-label prescribing occurs when a drug approved by the Food and Drug Administration (FDA) is used to treat a condition for which the FDA has not approved it. Doctors are legally permitted to prescribe drugs for off-label purposes, but drug makers can't promote their medications' off-label benefits.

Lead study author Dr. Christopher Wittich of the Mayo Clinic writes, "Since the U.S. Food and Drug Administration does not regulate the practice of medicine, off-label drug use has become very common." In fact, a 2006 report sighted by Wittich and his team shows that roughly one in five prescriptions filled in this country were for off-label uses, like anti-depressants being prescribed for the treatment of neuropathic pain. While the practice can prove beneficial to some patients, Wittich says, "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."

As a patient, educating oneself about off-label drug use can be particularly difficult, since you often are not aware that your physician is recommending a medication that has not received FDA approval to treat your individual condition. Doctors are not required to disclose to their patients when they are prescribing an off-label drug; they are also not liable for injuries that occur as a result of off-label prescribing.

Since doctors don't have to tell their patients about off-label prescriptions, the burden falls on the patients to educate themselves about their medications. Even those who conduct extensive research may, however, still find they are surprised by negative side effects resulting from off-label drug uses. If you or a loved one has been injured by a prescription medication, whether it was prescribed for on-or-off-label purposes, you may be entitled to compensation. Contact the drug injury attorneys at Arnold & Itkin today for a free consultation regarding your case.