FDA Puts Black Box Warning on Over 200 Opioid Prescription Drugs

The U.S. Food and Drug Administration announced yesterday it will require “black box” warnings on all immediate-release opioid pain medications. The target of the warning is prescribers.

“Today’s actions are one of the largest undertakings for informing prescribers of risks across opioid products, and one of many steps the FDA intends to take this year as part of our comprehensive action plan to reverse this epidemic,” said Dr. Robert Califf, the FDA commissioner, in his agency’s press release.

The warning is the strongest that the FDA can issue and will apply to 87 brand-name prescription drug medicines and 141 generic drugs according to the Advisory Board Company. The immediate-release opioid medications account for 90 percent of prescribed opioid medications on the market.

In 2013, the FDA put similar warnings on extended-release prescription pain-killers. At that time, they believed that the long-acting prescriptions (taken once or twice a day, as opposed to every 4-6 hours in the case of the immediate-release formulations) were more likely to lead to prescription drug abuse.

Earlier in March, the Center for Disease Control and Prevention released guidelines for prescribing opioid prescription drugs.