Caronia, the Second Circuit Court of Appeals overturned the criminal conviction of a pharmaceutical sales representative who was punished for promoting off-label
use of the drug Xyrem.
The first, overturning a decades-old prohibition of the off-label
detailing of drugs, surprisingly was decided against the government.
() The prescribing of drugs for nonFood Drug Administration (FDA) approved uses is called as "off-label
prescribing."  Off-label
use also includes the use of pharmaceutical drugs in unapproved age group, dosage, or form of administration.
Because Part D lacks adequate oversight for off-label
drug usage, pharmaceutical companies obtain windfall profits for drugs that have not been proven effective for off-label
If approved, ONS-5010 has potential to mitigate risks associated with off-label
use of Avastin or other drugs.
Many clinicians are prescribing the gabapentinoid drugs pregabalin (Lyrica) and gabapentin (Neurontin) for off-label
treatment of pain, despite a lack of supporting data or approval from the Food and Drug Administration, according to investigators.
(8-10) Other articles (11-13) called for a moratorium on the off-label
use of glucose meters following sentinel events in at least two New York State hospitals in early 2014, which required greater scrutiny of the use of these devices in hospitals.
Q Is it safe to take a drug "off-label
?" My doctor recommended I do so.
men ages 50 and older (average age 71.2) from 2007 to 2016 and compared testosterone prescriptions written for on-label and off-label
Klein and her colleagues conducted a study aimed at identifying the off-label
medications being prescribed to potentiate sleep in children with ADHD, and the characteristics of the children and their prescribers.
Yet drug- and device-makers have continued to push for more and more freedom to market products "off-label
," promoting products to groups and for uses that were never approved--maybe never even tested at all!