([4,5])
Off-label use of drugs in psychiatry setting is a very common feature.
Only a few months ago, the FDA tried yet again to punish a company for sharing information about its products'
off-label use, this time threatening representatives of Vascular Solutions for telling doctors that one of their company's medical devices could treat different kinds of varicose veins.
The absence of FDA approval has not deterred physicians from recommending aspirin's
off-label use to prevent critical cardiovascular issues.
Unlicensed and
off-label use in an Australian neonatal intensive care unit.
(147.) Note that this variable is distinct from the frequency of
off-label use (variable 1).
After many years of
off-label use it was approved for this use in 1979 (Farley 1992).
Though doctors already could prescribe Vascepa to those patients as an "
off-label use," Amarin (and other drug companies with products having off-label benefits) wasn't allowed to discuss such use with either doctors or patients.
The ability to call attention to an
off-label use, previously uncommon in product labeling, is just one example of how pediatric information can be made more readily available to health care providers as a result of these regulatory changes.
See Alexandra Ossola, FDA Allows Company To Market Drug For
Off-Label Use: Some Experts Predict That More Companies Will Try To Do The Same, Popular Science (Mar.
Clozapine has been available for decades, but relatively little has been published regarding its
off-label uses. This data shortage likely is due in part to clozapine's strict monitoring requirements, and we suspect
off-label use is more commonplace than the literature reflects.
PDT and topical agents effectively provide field treatment, and do not just address discrete lesions, although field treatment is technically an
off-label use for these modalities, he added.
However, direct regulation of
off-label use raises its own constitutional concerns.