The FDA has ordered a class-wide label change for long-acting opioids such as OxyContin (oxycodone) aimed at limiting use of these drugs to patients with severe, refractory pain.
The move, announced at press briefing Tuesday, is part of a handful of changes that the agency hopes will curb an ongoing prescription painkiller epidemic, including a label clarification about the risks of abuse and death with the drugs, a requirement for additional postmarketing studies, and a boxed warning about the risks of neonatal opioid withdrawal syndrome.
