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Andrew D'Arcy
Andrew D'Arcy
Attorney • (609) 641-6200


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The Food and Drug Administration announced on Tuesday that it was requiring new “boxed warnings” for immediate-release (IR) opioid pain medications such as Oxycontin, Percocet and Vicodin.  Hoping to curb a national epidemic of prescription painkiller abuse, the FDA is requiring a new boxed warning about the serious risks of misuse, abuse, addiction, overdose and death.  The plan is focused on policies aimed at reversing the epidemic, while still providing patients in pain access to effective relief.

Prescription opioid painkillers are divided into two main classes – extended release, which have more pain-killing opioid per dosage, and immediate release, which have less opioids, but need to be taken more frequently.  The FDA said that ninety percent of opioid prescriptions are for immediate-release painkillers.

The move by the FDA comes one week after the U.S. Centers for Disease Control and Prevention announced tough new guidelines to doctors for opioid drugs.  FDA Commissioner Dr. Robert Califf told reporters at a news briefing that “We are at a time when the unfathomable tragedies resulting from addiction, overdose and death has become one of the most urgent, devastating public health crises facing our country.”

In December, the CDC announced that fatal drug overdoses had reached record highs in the United States driven largely by the abuse of prescription painkillers and another opioid, heroin.  According to the December report, more than 47,000 Americans lost their lives to drug overdose in 2014, a 14 percent jump from the previous year.  Drug overdoses now kill more people in the United States than car crashes.

The new “boxed warnings” will now include warnings of potential harmful interactions of the drug with other medicines “that can result in a serious central nervous system condition called serotonin syndrome” according to the agency.  Labels will also warn of possible glandular or hormonal changes linked to opioid use.

Dr. Harshal Kirane, who directs addiction services at Staten Island University Hospital in New York City is quoted as saying “The opioid abuse epidemic can impact any of us, so it requires all of us to bring about sustainable change.”  The FDA is working with other agencies, drug makers, doctors and patients to prevent abuse and save lives.