Off-Label Usage of Medications (Pharmacology)
“Off-label” means the medication is being used in a manner not specified in the FDA’s approved packaging label, or insert. Every prescription drug marketed in the U.S. carries an individual, FDA-approved label. This label is a written report that provides detailed instructions regarding the approved uses and doses, which are based on the results of clinical studies that the drug maker submitted to the FDA.
“Many people may be surprised to know that the FDA regulates drug approval, not drug prescribing, and … doctors are free to prescribe a drug for any [reason they think is medically appropriate],” says G. Caleb Alexander, MD, MS, a medical ethics advocate and assistant professor of medicine at the University of Chicago Medical Center. “Off-label use is so common, that virtually every drug is used off-label in some circumstances.”
Unaware of Off-Label Usage of Pharmacology
Despite the prominence of off-label drug use, experts say few patients are aware that they are receiving a drug off-label. And doctors are not required to tell a patient that a drug is being used off-label.
Atlanta suburbanite Michelle Murphy was stunned to learn nadolol, the beta-blocker medicine she had been taking every day for several years to prevent migraines, was not actually approved for that use.
“It’s almost like we are test subjects, being reassured that everything will be fine because it worked to help people in studies that were taking it, but not exactly for what we are taking it for,” Murphy says.
The link below is to an article in Consumer Reports. Everyone needs to be aware of this information especially those who are prescribed psychotropic drugs or cardiac and hypertension medications. Click here to read the FDA definition of Off-Label Usage and you will see that off-label usage by ‘medical practice’ definition is functioning with little, if none, legal liability and sadly the patient lives with the consequences.
Doctors Often prescribe medication to treat problems the Drugs drugs are not officially approved for, which can be good—and bad—for patients
Editor’s Note: These materials were made possible by a grant from the state Attorney General Consumer and Prescriber Education Grant Program, which is funded by the multi-state settlement of consumer fraud claims regarding the marketing of the prescription drug Neurontin (gabapentin).
Comment by Van Harding: After reading this article ponder ask yourself this question: Many MDs discourage treatment by acupuncture and nutraceuitcals because there’s lack of scientific trials in the USA and they reject research from other countries. BUT, if my medical doctor is treating me with medication(s) which causes many side effects and is doing so without scientific trials through the FDA via Off-label Usage, why then should I limit myself from utilizing acupuncture which has none or little side effects?”
Is WebMD Impartial regarding Off-Label Usage?
The following article on WebMD gives only a partial view of the Off-Label Usage. Please read this after you have read the article above in Consumer Reports to see how there is a certain perception conveyed in WebMD by the omission of detailed information that is in the Consumer Reports article. It is important as a patient to be your own advocate and to gather information from independent parties.