NEWARK – Attorney General Christopher S. Porrino and the Division of Consumer Affairs today warned the public about the grave risks involved in using the potent prescription painkiller “Subsys” for anything other than its approved use to treat breakthrough pain in cancer patients already on round-the-clock opioid painkillers.

The State issued the public alert after filing an action seeking the temporary license suspension of a Cherry Hill doctor who prescribed Subsys to a non-cancer patient who later died from “adverse effect of drugs.”

Prescribing Subsys for anything other than its approved use, a practice known as “off-label” prescribing, carries an increased risk of misuse, abuse, addiction, overdose, and death. The medicine is not for use in opioid non-tolerant patients because life threatening respiratory depression and death could occur at any dose in patients not taking chronic opioids.

“We’re warning everyone – doctors and patients alike – that Subsys is a fast-acting, extremely powerful drug approved only for a singular narrow purpose – to relieve breakthrough cancer pain,” said Attorney General Porrino. “Given this risk, I have instructed the Division of Consumer Affairs to investigate the potential misuse of this highly addictive medication by other providers.”

Last week, as part of an Attorney General initiative to determine whether doctors have been prescribing Subsys according to United States Food and Drug Administration Guidelines, investigators with the Enforcement Bureau within the Division of Consumer Affairs inspected patient records at six doctors’ offices statewide, and subpoenaed patient records from 10 others. Inspections and investigations of off-label prescribing of Subsys will continue as part of this initiative.

Any physicians who prescribe Subsys for any other use are deviating from the regulatory standard of care deemed appropriate for this drug and are exposing their patients to a grave risk of a fatal overdose.”

Subsys is the brand name of one of six transmucosal immediate release fentanyl (“TIRF”) medications that instantly deliver the drug through the oral membranes. Subsys is a spray version of fentanyl, which is typically administered under the user’s tongue. Fentanyl generally is a powerful synthetic opioid painkiller that is similar to morphine, but is 50 to 100 times more potent. Recently, fentanyl has increased in popularity as a recreational drug, diverted from its legal use as a Schedule II pain medication, and is often either used by itself or in connection with heroin. Fentanyl, in both diverted and illegal analog forms, now results in thousands of overdose deaths every year nationally.

The only federally-approved use for TIRF substances, including Subsys, is for the management of breakthrough pain in adult cancer patients who are already receiving, and who are tolerant to, around-the-clock opioid therapy for their underlying persistent cancer pain.

Because the medicine carries a high risk for misuse, abuse, addiction, overdose, and serious complications due to medication error, the FDA has created a separate prescription protocol to monitor them. The TIRF REMS (Risk Evaluation and Mitigation Strategy) Access Program requires prescribers to undergo training about the drug’s risks, pass a test, and register in a national database.

“Any physician found prescribing Subsys to patients not qualified for the treatment will be subject to disciplinary action,” said Steve Lee, Director of the Division of Consumer Affairs. “We will not allow patients’ lives to be endangered by prescribers who disregard the federal restrictions placed this on this drug.”

The Attorney General’s Office and the Division of Consumer Affairs have undertaken a series of initiatives to combat heroin and opiate abuse in New Jersey, including the creation and upgrading of the New Jersey Prescription Monitoring Program database, which collects prescription data on Controlled Dangerous Substances (CDS) and Human Growth Hormone (HGH) dispensed in New Jersey, and Project Medicine Drop, which enables New Jerseyans to dispose of their unwanted medications, 24 hours a day, 7 days a week.

Recently, the Director of the Division of Consumer Affairs executed an emergency order to ban the manufacture, distribution and sale of seven illicit fentanyl analogs, including furanyl fentanyl and carfentanyl. These analogs have no legitimate medical purpose and have been linked to abuse, overdose, and even death.

Patients who believe they were prescribed Susbys in violation of the FDA restrictions should contact the Division of Consumer Affairs at 1-800-242-5846 (toll free within New Jersey) or 973-504- 6200.