When you take medication prescribed by your doctor, do you bother asking what the drug is really for? Probably not. Beware, though: the drug you’re taking may not actually be FDA-approved for your specific ailment. Got stage fright? You may be taking a blood pressure pill. Can’t sleep? You may be using an antipsychotic drug. Now before you call the medical board, you should understand that this practice, called off-label prescribing, is legal and common.
When a drug is used off-label, it means that the drug is used for a different medical condition other than what it’s approved for. It may be given to the patient differently, e.g. injection instead of oral. The dose prescribed may not follow what’s indicated on the label. Also, a drug approved for a specific stage of a disease may be used at a different stage. In any case, the practice deviates from what’s specifically indicated on the FDA-approved label.
The big pharmas save millions by not submitting testing results of second, third and up use for FDA approval, but they are also prohibited from marketing a drug’s off-label use. A legal loophole, however, gives clinicians the authority to prescribe off-label use of the drug if they believe it can improve the patient’s condition. As a result, they only have to find the doctors willing to promote their drug off-label for their profit schemes.
So why is off-label prescription risky? Generally, once a drug is approved, any licensed clinician can use it for whatever purpose he deems medically appropriate. Since the drug label is one of the most reliable information sources for health professionals, however, the drug is used without sufficient clinical support. “Off-label prescription puts the patients in higher risk of medication errors or even fatal side effects, in which case a legal action can be taken”, a seasoned Long Island, NY personal injury lawyer says.
In one case, the plaintiff was awarded $3,459,892, where a 15-year old girl hanged herself three weeks after visiting the clinic for vomiting, abdominal pain and nausea. It was found that the nurse practitioner prescribed, aside from anti-nausea medications, fluoxetine for depression, prompting the FDA to issue a public warning that the drug increases the risk of suicidal thinking in adolescents.
Except when supported by medical literature and/or clinical trials by professional health organizations, doctors, therefore, have to balance safety risk and benefits of off-label uses for patients. If you suspect that off-label prescription has something to do with the death of a loved one, you are entitled to compensation from the clinician or manufacturer at fault. Seek the help of experienced Long Island personal injury attorneys from firms like the Offices of Joseph M. Lichtenstein.
Source: Off-label drug prescribing: What does it mean for you? Consumer Reports
Source: The Perils of Off-Label Prescribing, Medscape.com