Off Label Use

The use of a drug (e.g., tretinoin, an analogue of vitamin A) or medical device (e.g., injectable collagen) to treat a condition for which it has not received approval by a regulatory agency—e.g., the FDA. Off-label use is most common in chemotherapy of difficult-to-treat cancers, for which there is no agreement on standardised therapy
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The harm done by Neurontin's off label use, he noted, extends well beyond suicide.
A few years ago, after some hearings, the FDA decided that companies couldn't promote off-label uses, but if doctors ask [pharmaceutical salespeople] about off-label uses or want to see any articles in the literature about off-label uses, it's OK for drug companies to make those articles available and to allow their representatives to talk about those off label uses.
Another example relates to the widespread off label use of a class of drugs called calcium channel blockers (CCBs).
Even more dramatically, William Schultz (1996), deputy commissioner for policy at the FDA, has claimed, "some off label uses could be approved by the FDA if the sponsor would simply compile the existing literature and submit it to us.
Another off label use for hcg shots are in conjunction with people using anabolic steroids for testosterone replacement therapy purposes or for people using these steroids illegally for bodybuilding or athletic purposes.
May 29, 2013 /PRNewswire-iReach/ -- HCG off label uses
Maercks developed expertise with all technologies and found a way to maximize their effects by combining them in off label uses together, delivering documented results in a single treatment.
has agreed to pay more Indian $425 million to settle claims that it inappropriately marketed three drugs for off label uses, according to the U.
Now, the use of growth hormone in short stature children is focusing debate on another set of issues, including the high cost of bioengineered therapies (one can assume cost will be an element of virtually all health policy discussions), off label uses of drugs, diffusion of medical practice that outpaces the underlying science, and the associated ethical issues.
drugs including off label uses and dosages; powerful reporting capabilities for drug interactions, adverse reactions, contraindications, cost data and IV compatibilities; advanced search features for drug look-up by indication, contraindication, adverse effects and therapeutic classification and more.