Since its introduction in 2012, the U.S. Food and Drug Administration’s (FDA’s) Adverse Events Reporting System has listed 203 deaths linked to Subsys. During the first half of 2015 alone, Subsys-related deaths has continued to accelerating, registering as many as 52 deaths.
Subsys is the first and only sublingual spray that contains fentanyl, an extremely powerful opioid painkiller with a strength that is 80 to 100 times greater than morphine. It is produced by Insys Therapeutics, Inc., and was approved by the FDA to manage intense and rapid flare-ups of pain (due to cancer) in adults who are opioid tolerant. By working in the brain to change how the body feels and responds to pain, Subsys is able to effectively provide relief within just five minutes after spraying it under the tongue.
The risk of abuse, addiction and overdose makes Subsys a dangerous and deadly drug to children and all other individuals who are not opioid tolerant. Despite the dangers associated with the use of this drug, Insys Therapeutics is said to have aggressively marketed it for off-label use – a marketing strategy that the federal law strictly prohibits drug companies from ever doing (doctors may, however, prescribe drugs for off-label use).
Besides overdose, abuse, misuse and addiction, Subsys has also been found to cause other side-effects, which include nausea, vomiting, somnolence, constipation,respiratory depression (which can lead to apnea),circulatory depression, hypotension, shock, slow heart rate, feeling like passing out, and fatal breathing problems.
Due to the dangers associated with the use of Subsys, it is made available only through a certified pharmacy and under a special program, called the Transmucosal Immediate-Release Fentanyl (TIRF) REMS Access program. Those who need to get Subsys, even healthcare providers, must first register under this program.
As explained by a Subsys spray death lawyer, victims of accidental overdose caused by fentanyl products, like Subsys, may be eligible to file a lawsuit against this drug’s manufacturer, or the healthcare provider that prescribed this drug.