Only three years after Insys Therapeutics, Inc., placed Subsys on the market in 2012, the drug has already earned record profits for the company, earning $147.2 million for Insys during the first six month of 2015 alone.
Subsys is the first and only fentanyl sublingual medicine that is sprayed under the tongue and which claims to be able to relieve adults with cancer from breakthrough pain in as little as five minutes. Due to the major content of this medication, however, fentanyl, which belongs to a class of drugs known as opiate or narcotic analgesics, Subsys can cause abuse, overdose, addiction, or death. These risks made the U.S. Food and Drug Administration require that the purchase of Subsys be permitted only to healthcare professionals who prescribe Subsys to outpatients, to outpatients, to distributors and pharmacies, enrolled in the Transmucosal Immediate-Release Fentanyl (TIRF) REMS Access program.
Besides the fact that Subsys should be used only by adult cancer patients who are opioid tolerant, warning is strongly made against sharing this medicine with people to whom it has not been prescribed, but most especially against using it on children since its fentanyl content can prove fatal to a child.
For Subsys users, side-effects of this medicine include, but are not limited to: breathing problems (especially to severely ill and malnourished patients), drowsiness, allergic reaction (like swelling of face, lips, tongue, or throat), slow heart rate, severe drowsiness, feeling like passing out; rapid heart rate, confusion, extreme fear, unusual thoughts or behavior, and trouble concentrating. For pregnant women, use of Subsys can cause their baby to become dependent on fentanyl which, in turn, can cause life-threatening withdrawal symptoms after the baby is born.
Besides being accused of illegally promoting Subsys to doctors in ways that violate of FDA rules, Fentanyl spray lawsuit also link use of Subsys to overdose in patients.