Off-Label Drug Use May Be Risky

The February 2017 issue of Consumer Reports article, “Should Drugs Do Double Duty” says, “Your doctor might give you a drug for a condition that it’s not approved to treat. That’s a risk you may not want to take.”

“Doctors routinely (and legally) prescribe drugs “off label” — that is, for conditions not approved by the FDA–for any use they see fit. Most don’t tell their patients. The results of this practice are alarming.”

Klonopin (clonazepam), an anti-anxiety drug, is routinely prescribed off-label for restless leg syndrome and insomnia, for which there is insufficient evidence for its effectiveness — let alone the fact that it poses an addiction risk and a risk of birth defects when prescribed to pregnant women.

Trazodone, an antidepressant, is routinely prescribed off-label for insomnia, but a black box warning says it increases suicidal thinking in children, teens, and young adults.

Seroquel (quertiapine) and Abilify (aripiprozole), antipsychotics, are routinely prescribed off-label for dementia, but the FDA has issued black box warnings about their use by people with dementia, which ups their risk of death. By the way, it doesn’t actually treat dementia, it is only used to suppress a person’s agitation.

“One reason drug companies may want more freedom to market or advertise drugs for unapproved uses is to eliminate financial penalties for off-label promotions.” Johnson & Johnson was fined $2.2 billion in 2013 for illegally promoting the off-label use of the antipsychotic Risperdal (risperidone). GlaxoSmithKline was fined $3 billion in 2012 for promoting the off-label use of the antidepressant Paxil (paroxetine).

All the more reason to learn how to protect yourself, your family and friends, with full informed consent. Courts have determined that informed consent for people who receive prescriptions for psychotropic (mood-altering) drugs must include the doctor providing “information about…possible side effects and benefits, ways to treat side effects, and risks of other conditions…,” as well as, “information about alternative treatments.”

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