FDA Now Requires ‘Black Box’ Warning On Pain Killers

In an attempt to help slow the prescription drug epidemic, the US Food and Drug Administration announced Tuesday that immediate release opioid painkillers such as oxycodone and fentanyl will now have to carry a “black box” warning about the risk of abuse, addiction, overdose and death. Prescription opioid painkillers are divided into two main classes – extended release, which have more painkilling opioid per dosage, and immediate release, which have less opioids, but need to be taken more frequently. 90% of opioid prescriptions are for immediate release painkillers, the FDA said.

When a patient gets his or her prescription filled, the bottle should have a notification indicating there is a black box warning for the drug. The consumer would need to go to the manufacturer’s website for details. In addition, pharmacists are encouraged to provide patients with a medication guide – consumer friendly language explaining the risks of the drug. Under this new effort from the FDA, all instant release drugs will need to have such a guide. It is up to the pharmacist to dispense this information, something the FDA encourages.