NJ attorney general launches statewide investigation into 'off-label' fentanyl prescribing practices after patient death

On Monday, New Jersey Attorney General Christopher S. Porrino issued a warning to the public regarding the use of the opioid medication Subsys. The warning follows the death of a patient who was prescribed the drug "off label," or not in accordance with recommended prescribing practices. Mr. Porrrino is seeking to suspend the prescribing physician's medical license and has launched a statewide investigation into Subsys' prescribing practices.

Subsys, an aerosolized version of the potent opioid fentanyl, is typically administered beneath the tongue. It is only approved by the Food and Drug Administration for use in cancer patients dealing with breakthrough pain persisting through treatment with other opioid pain medication. Sarah Fuller, whom was prescribed Subsys by Vivienne Matalon, MD, of Cherry Hill, N.J., was seeking relief for back and neck pain and did not have cancer, according to STAT.

"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, investigators with the Enforcement Bureau within the Division of Consumer Affairs inspected patient records at six physicians' offices across New Jersey and subpoenaed patient records from 10 more.

"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 on this drug."

The complaint filed by the attorney general against Dr. Matalon with the New Jersey State Board of Medical Examiners, according to STAT, alleges the internal medicine physician "indiscriminately" prescribed Subsys. Mr. Porrino requests that Dr. Matalon have her license revoked or suspended because her practice "presents a clear and imminent danger." The complaint also states that Ms. Fuller's family went to Dr. Matalon to help treat her pain via alternative methods as the patient had a history of opioid abuse. Dr. Matalon did not respond to STAT's request for comment.

Fentanyl, the painkilling compound found in Subsys, is 50 times more potent than morphine and, in recent months, has been linked to a string of overdose deaths in the U.S.

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