When a drug is used in a way that is different from that described in the FDA-approved drug label, it is said to be an “off-label” use. This can mean that the drug is used for a different disease or medical condition, given in a different way (such as by a different route), or given in a different dose than in the approved label.
Off-label use is very common (approx. 21% of prescriptions). The highest rates of off-label use are for anticonvulsants (74%), antipsychotics (60%), and antibiotics (41%). In an examination of off-label prescribing of 160 common drugs most off-label drug uses (73%) were shown to have little or no scientific support. Atypical antipsychotics and antidepressants were particularly likely to be used off-label without strong evidence.
So, with off label usage becoming so commonplace, are patients actually aware that they may be using a medication that was approved for a different purpose?
Patients Are Not Aware That Prescribed Medications Are “Off-Label”
Research by the Mayo Clinic shows patients are unaware that the medications they have been prescribed by their doctor aren’t being used in ways that would meet U.S. Food and Drug Administration approval.
Researchers point out that a 2006 report revealed that roughly one in five prescriptions were for an off-label use; which mirrors the results of previous studies. For example, some antidepressants are considered a primary treatment for neuropathic pain, although this use is not FDA-approved.
Morphine, as well as many inhaled bronchodilators, antimicrobials, anticonvulsants and proton pump inhibitors are also prescribed for children without being FDA-approved for use in kids. Previous research has shown that about 79 percent of kids were taking at least one off-label medication when they were discharged from a children’s hospital, the study authors noted in the release.
Because doctors are not required to disclose the off-label use of a drug, and are also not liable for off-label drug use, patients are commonly not told that they are taking a drug in a way that is not FDA-approved, the researchers pointed out.
Drug makers, however, are not allowed to promote off-label uses of their drugs. Doing so can result in hefty fines, the study authors explained. For example, GlaxoSmithKline recently agreed to pay a record $3 billion to settle a case involving alleged off-label drug-use marketing, and Merck Sharp & Dohme was fined $322 million for allegedly promoting the painkiller Vioxx for an off-label use.
But, Wittich and colleagues noted, drug companies are allowed to respond to questions from health care providers and distribute peer-reviewed publications about off-label drug use.
The high costs and lengthy process of obtaining FDA approval may deter drug companies from seeking approval for a new drug indication, the researchers suggested.
The report was published online Aug. 6 in the Mayo Clinic Proceedings.
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