Fentanyl, which is an extremely potent opioid painkiller that is up to 100 times greater in strength than morphine, was approved by the U.S. Food and Drug Administration (FDA) for treatment of late-stage breakthrough pain in adults cancer patients who are opioid tolerant or who have developed a tolerance for opioid medications.
Cancer patients would definitely be familiar with some fentanyl-containing medications, like: Duragesic, which is in the form of a skin patch; Actiq, which is in lozenge form; Abstral, a sublingual tablet or a tablet that goes under the tongue; Fentora, a tablet that is placed between the gum and the cheek; and, Subsys, a sublingual spray.
Subsys, a federally controlled substance (CII), is the first and only sublingual prescription pain medication that contains fentanyl; it is also the latest fentanyl-containing medication that is under legal spotlight due to allegations that Insys Therapeutics, Inc., its manufacturer, has illegally marketed this drug by promoting it for off-label use (promoting a drug for off-label use may be done by doctors but never by drug manufacturers).
Though acknowledged as effective, use of Subsys, like all other fentanyl-containing drugs, has been proven as posing great risk due to the possibility of its abuse, misuse, addiction and overdose. Besides its fatal effects in children, the drug can prove deadly too in used in patients who do are not opioid tolerant cancer patients.
The risks presented by Subsys has made its acquisition possible only by registering with the Transmucosal Immediate-Release Fentanyl (TIRF) Risk Evaluation and Mitigation Strategy (REMS) Access program, a restricted program of the FDA.
The risks, the more than 250 deaths linked to Subsys use (since its introduction in 2012), plus Insys Therapeutics’ illegal promotion or marketing of Subsys has landed this drug in the “drugs of concern” list held by the U.S. Department of Health and Human Services’ Inspector General.
Patients who have been inappropriately prescribed with this powerful opioid medication, Subsys, may find it necessary to seek legal assistance from a highly-skilled attorney, for help in filing a Fentanyl oral spray lawsuit,which may enable him/her pursue justice and the compensation from the liable party.Read More