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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 ...
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 ...
In 1993, the FDA approved gabapentin, marketed by Pfizer under the name "Neurontin", only for treatment of seizures.Pfizer subsidiary Warner-Lambert illegally used scientific activities, including continuing medical education and research, to commercially promote gabapentin, so that within five years the drug was being widely used for the off-label treatment of pain and psychiatric conditions ...
Some antidepressants, including sertraline (Zoloft) and paroxetine (Paxil) are used off-label to treat PE. Research shows that these medications help slow down climax and improve stamina for men ...
Off-label promotion Depakote: False Claims Act, FDCA 2009 Eli Lilly [9] $1.4 billion Off-label promotion Zyprexa: False Claims Act, FDCA 2001 TAP Pharmaceutical Products [10] $875 million Medicare fraud, kickbacks Lupron: False Claims Act, Prescription Drug Marketing Act: 2012 Amgen [11] $762 million Off-label promotion, kickbacks Aranesp ...
Fexofenadine is used for relief from physical symptoms associated with seasonal allergic rhinitis and for treatment of hives, including chronic urticaria. [12] It does not cure, but rather prevents the aggravation of allergic rhinitis and chronic idiopathic urticaria, and reduces the severity of the symptoms associated with those conditions, providing relief from repeated sneezing, runny nose ...
Prescription cascade is the process whereby the side effects of drugs are misdiagnosed as symptoms of another problem, resulting in further prescriptions and further side effects and unanticipated drug interactions, which itself may lead to further symptoms and further misdiagnoses.
To highlight this concern, the doctors and editors of Best Buy Drugs publish drug-safety reports to draw attention to the adverse effects and risks of prescription drugs, such as Celebrex and Alli. The reports are created by the Best Buy Drugs team and an independent academic group, Research on Adverse Drug Events and Reports (RADAR) , devoted ...