FDA to require strongest warning on some opioid painkillers

(Reuters) - The U.S. Food and Drug Administration on Tuesday set broad safety guidelines, including requiring some opioid pain drugs to carry the strongest safety warning, as part of its effort to combat a growing epidemic of opioid addiction and overdose.

The news comes a week after the U.S. Centers for Disease Control and Prevention (CDC) released voluntary guidelines instructing primary care doctors to sharply reduce the use of opioids for chronic pain.

Overprescribing opioids, largely for chronic pain, is a key reason for America’s drug-overdose epidemic. Nearly 2 million Americans aged 12 or older either abused or were dependent on prescription opioids in 2014, the CDC said.

The FDA said short-acting opioid pain medications would be required to carry on their labels the strongest form of warning about the risks of misuse, abuse, addiction, overdose and death.

The regulator will require the warning to include that chronic use of short-acting opioids during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening.

The FDA said it would also require several additional safety labeling changes across all prescription opioid products to include additional information on the risk of these medications.

The agency said its plan was aimed at reversing the epidemic, while still providing access to effective pain relief.

"Today's actions ... one of many steps the FDA intends to take this year as part of our comprehensive action plan to reverse this epidemic," said FDA Commissioner Robert Califf.(

Reporting by Natalie Grover and Ankur Banerjee in Bengaluru; Editing by Anupama Dwivedi