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Off Label Drug use. what you need to know

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What you need to know

Prescription drugs are often prescribed for uses other than what the FDA has approved. Find out why.

The next time your doctor writes you a prescription, consider this: The medication may not be approved for your specific condition or age group.

But you probably shouldn't call the medical board.

 

The practice, called "off-label" prescribing, is entirely legal and very common.

More than one in five outpatient prescriptions written in the U.S. are for off-label therapies.

"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

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.

Benefits of Off-Label Drug Use

Off-label prescribing isn't necessarily bad.

It can be beneficial, especially when patients have exhausted all other approved options.

Off-label use of a drug or combination of drugs often represents the standard of care.

It's not uncommon for off-label uses to eventually get approved by the FDA.

A risky practise

There is debate about off-label drug use.

Doctors emphasize that off-label prescribing has its place in medical practice,

but they also admit that using a drug off-label can raise the risk of lawsuits should a patient have unwanted or bad side effects.
"Off-label prescribing can expose patients to risky and ineffective treatments," medical ethics professor Rebecca Dresser and Joel Frader, MD, write in the fall 2009 issue of The Journal of Law, Medicine & Ethics. 

Although some off-label therapies can be beneficial and even lifesaving for some patients,

in most cases, there is little or no scientific evidence to prove they work. 

An Issue for Doctors

Psychiatric medicines are among the most common drugs to be prescribed off-label, and their use in children is of special concern. Many drugs prescribed to children are used off-label because medications are less commonly tested in this age group. In March 2009, researchers reported in Academic Pediatrics that 62% of outpatient pediatric visits resulted in an off-label prescription. Children under age 6 were most likely to be prescribed a drug off-label.

 

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