The Food and Drug Administration will require a class-wide label change for long-acting opioids aimed at limiting use of these drugs to patients with severe, refractory pain.
NPR: FDA Ratchets Down On Prescribing Of OxyContin And Other Opioids
The Food and Drug Administration today took another step toward restricting use of OxyContin and other powerful and often-abused prescription pain medications. The move comes amid an emotional debate over so-called long-acting opioid analgesics. Federal health officials and others are concerned about the rising number of Americans who are getting addicted to the drugs and overdosing on them. Pain specialists and their patients, however, fear that restrictions risk making it too hard for patients who need the drugs to get them (Stein, 9/10).
Medpage Today: FDA Tightens Opioid Labeling
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 (Fiore, 9/10).