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Off-Label Use Overview
When a medication is prescribed for the treatment of a condition that was not evaluated and approved by the U.S. Food and Drug Administration, it is known as off-label prescribing.
While it may sound sketchy, it’s perfectly legal and often clinically beneficial for physicians to prescribe a drug for a use other than one the FDA has formally approved.
Here are a few common examples of off-label use provided by the Pharmacy Times:
- Two hypertension drugs are used to treat psychological issues. Prazosin (Minipress) and clonidine (Catapres) are approved and normally prescribed for the treatment of high blood pressure. However, prazosin has been found effective for helping patients who experience nightmares as a result of post-traumatic stress syndrome, while clonidine is prescribed for ADHD and other psychological disorders.
- Naltrexone (Revia) is normally used to treat addiction, such as alcoholism and opioid dependence. Doctors also prescribe naltrexone for fibromyalgia and self-destructive behaviors.
- Naladol (Corgard) is another anti-hypertension medication that doctors have found useful in the treatment of migraines.
- One of the most common off-label prescriptions involves the use of simple aspirin, a general pain reliever, to reduce the risk of blood clotting and stroke.
According to WebMD, a prescription may also be considered “off-label” if the physician prescribes it in a way that differs from the label instructions, or at a different dosage.
Legally, any licensed physician may write an off-label prescription if, in his or her professional opinion, the medication is the best treatment option for the patient’s disorder. While doctors may inform their patients that they are being given an off-label prescription, they are not required to do so.
There are a number of reasons why a doctor may resort to off-label prescribing, the primary ones of which are that the patient has failed to respond to standard treatment, or that there is no other suitable or effective treatment for the patient’s condition.
Legal Issues
While physicians have the legal right to prescribe medications for the treatment of unapproved conditions — regardless of whether or not they inform their patients — drug companies may not, under any circumstances, promote or advertise one of their products for any purpose or treatment other than that for which the FDA granted approval.
Unfortunately, this is what a number of drug companies have been accused of doing. Plaintiffs in injury lawsuits have claimed that some drug makers have engaged in aggressive marketing and promotion campaigns claiming that their products are safe and effective for the treatment of illnesses for which they have never been tested or approved.
Lawsuits and Settlements
In 2015, according to Drug Safety News, Johnson & Johnson was accused of promoting Risperdal, a drug approved for the treatment of schizophrenia and bipolar disorder, as a treatment for dementia. Although studies reportedly showed that Risperdal offered a “slight benefit” for dementia victims, the risks of stroke, heart attack and movement disorders far outweighed the benefits – which was why the FDA did not approve the medication for anything other than the aforementioned mental disorders.
That same year, reported Drug Safety News, U.K. pharmaceutical company GlaxoSmithKline paid a $1 billion fine for promoting Zofran, a drug approved for treating nausea associated with cancer treatments, for morning sickness. Infants born to women who took Zofran for this purpose reportedly wound up suffering birth defects.
Testosterone products, as well as vaginal rejuvenation procedures, have also come under legal scrutiny for allegedly inappropriate off-label promotion.
