It said Tuesday that all fast-acting opioid pain medicines will be required to carry its strongest warning about risks, including the risks for abuse, addiction, overdose and death.
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Prescription opioids often combine oxycodone with lower-grade medications.
The labels for immediate-release opioids will now say that they should only be prescribed when there are no alternative treatments.
“Heroin-related deaths jumped 39% from 2012 to 2013, and the longer-term trends are equally disturbing: from 2002 to 2013, the rate of heroin-related overdose deaths almost quadrupled, according to the Centers for Disease Control and Prevention”, Katharine Q. Seelye reported for the New York Times in a “guide to the drug’s spread and impact” last October. When prescribing opioids for short-term pain, the agency said doctors should prescribe a 3-day supply, whenever possible. But Califf said the FDA was limited in what it could do.
A year-old opioid initiative within the Department of Health and Human Services is focusing on three priority areas: informing opioid prescribing practices, increasing the use of naloxone (a rescue medication that can prevent death from overdose) and expanding access to and the use of Medication-Assisted Treatment (MAT) to treat opioid use disorder. However, FDA officials felt the long-acting, extended-release formulations were leading to more prescription drug abuse.
Critics of the FDA, including Physicians for Responsible Opioid Prescribing, called on the agency to add such warnings years ago. Many prescription opioid abusers eventually switch to heroin because it sells for up to five times less than pills or tablets.
As per the FDA research paper published by the study team, “The FDA is also requiring several additional safety labeling changes across all prescription opioid products to include additional information on the risk of these medications”.
Government officials have tried a variety of approaches to tackling painkiller abuse in recent years.
New warnings on opioid drug labels include information about the dangers of misuse or abuse, abruptly halting their use, use during pregnancy and potentially adverse interactions with other drugs, according to the FDA.
Immediate-release opioid painkillers include nearly 175 different brands and generics, including Vicodin and Percocet.
And, Florida and NY have cracked down on “pill mills” by using databases to monitor what doctors are prescribing.
The FDA and Califf in particular have come under fire from some senators who have been highly critical of Califf’s role in what they said is an underwhelming agency response to the prescription opioid epidemic.
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.
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“We know that there is persistent abuse, addiction, overdose mortality and risk”, of newborn withdrawal syndrome associated with the painkillers, said Douglas Throckmorton, the FDA Deputy Center Director for Regulatory Programs in a statement on the new labels.
