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Off-label use is the use of pharmaceutical drugs for an unapproved indication or in an unapproved age group, dosage, or route of administration. [1] Both prescription drugs and over-the-counter drugs (OTCs) can be used in off-label ways, although most studies of off-label use focus on prescription drugs.
Other off-label uses include cancer pain, hot sweats, certain psychiatric disorders, nicotine dependence, opioid withdrawal, migraine headaches, and restless leg syndrome. Colchicine (Colcrys) for pericarditis: colchicine is indicated for the treatment and prevention of gout, though it is also generally considered first-line treatment for acute ...
The following are settlements reached with US authorities against pharmaceutical companies to resolve allegations of "off-label" promotion of drugs. Under the Federal Food, Drug, and Cosmetic Act, it is illegal for pharmaceutical companies to promote their products for uses not approved by the Food and Drug Administration (FDA), and corporations that market drugs for off-label indications may ...
While estimates vary, some studies suggest that 1 in 5 prescriptions of common medications involves an off-label use. Skip to main content. 24/7 Help. For premium support please call: 800-290 ...
Physicians legally can and often do prescribe medicines for purposes not listed in this section (so-called "off-label uses"). Contraindications - lists situations in which the medication should not be used, for example in patients with other medical conditions such as kidney problems or allergies
Just a small example of these include most antibiotics and all antidepressants or antidiabetic medications. Certain POM medicines are additionally marked Controlled Drug (CD) due to risk of abuse and the possibility of diversion for sale as street drugs. Examples of CDs include all benzodiazepines and strong opioids such as heroin and fentanyl.
Off label indications often have some clinical significance to back the use, but they have not gone through the extensive testing required by the FDA to have an official labeled indication. Drug companies can not provide any official medication information (e.g. package inserts ) for off label indications.
Off-label promotion/ failure to disclose safety data: 2012: Avandia/Wellbutrin/Paxil: False Claims Act/FDCA: Pfizer [137] $2.3 billion: Off-label promotion/kickbacks: 2009: Bextra/Geodon/ Zyvox/Lyrica: False Claims Act/FDCA Abbott Laboratories [138] $1.5 billion: Off-label promotion: 2012: Depakote: False Claims Act/FDCA Eli Lilly [139] $1.4 ...