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Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective drugs and side effects, is commenting on a recent study looking at off-label drug use. Medscape reports that JAMA Internal Medicine published a study on November 2, 2015 showing that off-label drug use is linked to higher rates of adverse events when compared to drugs that are used on-label, uses approved by the U.S. Food and Drug Administration (FDA). Off-label drug use indicates that a drug is being used in a manner not approved by the FDA. According to Medscape, the study found that a lack of substantial evidence to support off-label use was associated with the highest risk of adverse events. Study author Tewodros Eguale, MD, PhD, an epidemiologist at McGill University, Montreal, Quebec, Canada, and associate professor in the School of Pharmacy at MCPHS University, Boston, Massachusetts, said “[c]aution should be exercised in prescribing drugs for off-label uses that lack strong scientific evidence.” according to Medscape.
According to Medscape, researchers used electronic health records from a community-based clinical database to analyze data from 46,021 adults who received 151,305 prescribed drugs from 2005 to 2009. Most of the prescriptions were on-label (88 percent) but in 9.5 percent of the cases, drugs were prescribed off-label without strong supporting evidence. There were also cases of off-label use with strong evidence (2.3 percent). Overall, the rate of adverse events was 13.2 per 10,000 person-months. Researchers found that these events were more likely to occur with off-label use (19.7 per 10,000 person-months) compared to on-label (12.5 per 10,000 person-months). Furthermore, the study found the risk was especially prevalent among drugs that did not have solid evidence to back off-label use (21.7 per 10,000 person-months) compared to on-label use. Medscape reports that the most common adverse events linked to off-label use included: Akathisia from taking gabapentin for neurogenic pain, agitation associated with amitriptyline hydrochloride for migraine, hallucinations with trazodone hydrochloride for insomnia, QT interval prolongation with the use of quetiapine fumarate for depression, and weight gain with olanzapine for depression. http://www.medscape.com/viewarticle/854200?src=wnl_edit_medn_wir&uac=137192SJ&spon=34&impID=888128&faf=1
Parker Waichman comments that off-label drug use is the subject of numerous personal injury lawsuits. While physicians may prescribe a drug off-label for any purposes he or she sees fit, it is illegal for pharmaceuticals companies to promote off-label use of approved medications.
“Many lawsuits have been filed against drug makers who allegedly promoted their products for uses not approved by the FDA,” said Matthew J. McCauley, Senior Litigation Counsel at the firm. “As the findings of this study shows, off-label use may increase the risk of serious side effects, particularly when there is inadequate data to support these indications.”
For more information concerning drug reactions, please visit Parker Waichman’s Defective Drug page on its website at http://www.yourlawyer.com. Free case evaluations are also available by calling 1-800-LAW-INFO.
Release ID: 97520