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.
([1]) The prescribing of drugs for nonFood Drug Administration (FDA) approved uses is called as "
off-label prescribing." [2]
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 conditions.
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 use.
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!