Based on an analysis of US prescribing data, researchers identified 14 drugs for which future study on off-label uses is warranted. Specifically, the investigators noted a “high volume of off-label prescribing in the absence of good evidence for a substantial number of drugs, particularly antidepressants, antipsychotics and anxiolytic-sedatives.” The findings are published in the December issue of the journal Pharmacotherapy.

[ad]

The researchers used nationally representative prescribing data to estimate the number of off-label drug uses by indication from January 2005 through June 2007, and then categorised the indications according to adequacy of scientific support. The investigators analysed drug safety, the volume of off-label use with inadequate evidence and a composite of cost and marketing factors.

The list, which includes six antidepressants and three antipsychotics, was topped by AstraZeneca’s Seroquel (quetiapine). Researchers discovered that the schizophrenia drug was prescribed off-label 76 percent of the time, mainly to treat bipolar disorder, an indication for which the product was approved in October. Other treatments on the list are compounds that have been approved for hypertension, atrial fibrillation, asthma, joint sprain/strain and chronic renal failure.

Senior author Randall Stafford commented that “it’s not that these off-label uses are necessarily harmful or that these drugs don’t work,” but that the appropriate studies have not been done. In response to the findings, PhRMA spokesperson Diedtra Henderson said that the organisation could not comment on off-label prescribing. “That’s nothing being driven by our companies,” she remarked, adding that “this is an activity that our companies aren’t allowed to do under FDA regulations.”‘

Source: FirstWord

Popularity: 3% [?]