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Off-label use of breakthrough cancer pain drug linked to serious opioid addiction and death


Source: Subsys

Cancer patients who are receiving regular pain medication and management can sometimes still experience sudden, intense flare-ups called breakthrough pain.

Subsys, a fentanyl-based pain relief mouth spray, was developed by Insys Therapeutics and approved by the FDA to treat the condition. The drug delivers a painkiller mist 100 times more powerful than morphine for pain that can’t be addressed with other narcotics in the patient’s usual pain management medications. When used as directed, Subsys offers much-needed relief for cancer patients during intense breakthrough pain flares.

Unfortunately, the highly addictive drug can have severe consequences when it’s prescribed to non-cancer patients for off-label use. Some individuals suffering from chronic pain or other injuries and conditions received increasingly large doses of the expensive drug, which costs thousands to tens of thousands of dollars for a 30-day supply. Many of these non-cancer patients suffered complications including serious opioid addiction, overdoses, and even death.

Concerns about the dangers of off-label use of Subsys and the practices Insys used to market and sell the drug have come to light as the country battles a devastating opioid epidemic.

According to an NBC News investigative report, salespeople and company executives allegedly participated in unethical and illegal schemes to increase prescriptions and sales of the drug to non-cancer patients.

Doctors have been accused of taking bribes and kickbacks from the company for prescribing Subsys to patients who didn’t need it, and a whistleblower claims she was directed to lie to insurance companies to get the medication approved while working as a sales rep at Insys.

Elk & Elk is currently investigating claims that off-label use of Subsys for non-cancer patients was linked to serious complications including opioid addiction and death. Contact us today for a free consultation if you or a loved one were prescribed Subsys opioid pain relief mouth spray without a cancer diagnosis.