The US Food and Drug Administration (FDA) has approved an extended-release combination of oxycodone and acetaminophen (Xartemis XR, Mallinckrodt plc), previously known as MNK-795, for the management of acute pain severe enough to require opioid treatment, and for patients for whom alternative treatment options are ineffective, not tolerated, or would otherwise be inadequate. The drug…
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…
A coalition of 37 physicians that includes pain management and addiction experts petitionedthe US Food and Drug Administration (FDA) yesterday to tighten label restrictions for opioid analgesics as a way to combat the epidemic of addiction and fatal overdoses associated with these drugs. Under the proposed label changes, opioids would no longer be indicated for…