Piro Zinna Cifelli Paris & Genitempo, LLC Attorneys at law
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Off-label drug use can lead to death

Two doctors have lost their jobs, 16 offices were investigated, and the entire state of New Jersey was given an alert about the off-label use of a painkiller simply because one person died while using the drug.

Is this an overreaction to one accidental death? Probably not. However, the fact that the drug in question happened to be a powerful opiate that ended up killing a young, healthy woman instead of an anti-psychotic that was being given off-label to an elderly dementia patient probably contributed to the attention given to this particular case. The overuse of narcotic prescriptions has become a hot issue, politically and medically.

In this case, one of the doctors involved was banned forever from practicing medicine in New Jersey after the Board of Medical Examiners found that he'd prescribed Subsys, an oral painkiller approved only for certain cancer patients, to patients with far less severe conditions. The Board called it an act of gross malpractice.

However, the off-label use of many medications is common— and not every case is given the same attention when something goes wrong. While drug companies are forbidden to advertise drugs for potential off-label use, nothing stops their representatives from suggesting those uses to doctors in person. There's no law that says that doctors can't prescribe a drug off-label if they're convinced that it has some therapeutic benefit for the patient's condition.

That can lead to fatal outcomes for more than just those who suffer from chronic pain. In the case of the elderly patients given anti-psychotics, there's a statistically significant risk of stroke and sudden death involved. Yet, the drugs get prescribed even though conclusive evidence of their therapeutic benefit isn't there.

In many cases, patients and their caregivers are unaware that they're being prescribed a medication off-label. They assume that the drug is targeted for their particular condition, and the physician doesn't take adequate steps to explain otherwise. If they are told the drug is being used off-label, they're often reassured that there's no serious risk involved. In some cases, it's questionable how much the prescribing physician even really looks into the data surrounding the drug — they may just rely on what the pharmaceutical representative tells them it can safely treat.

If you suspect that a prescription used off-label was behind a medical injury or death of a loved one, consider discussing the situation with a personal injury attorney.

Source: South Brunswich Patch, "2 N.J. Doctors Lose Jobs, 16 Offices Probed After Statewide Alert For Deadly Drug," Tom Davis, Nov. 22, 2016

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