Senators urge FDA to implement risk management strategies for all prescription opioids

Sens. Richard Blumenthal (D-CT), Joe Manchin (D-WV), Edward Markey (D-MA), Angus King (I-ME), Kirsten Gillibrand (D-NY) and Chris Murphy (D-CT) yesterday urged the Food and Drug Administration to implement a Risk Evaluation and Management Strategy for immediate-release opioid pain relievers. The agency currently requires a REMS for extended-release and long-acting opioids. “While we applaud a REMS requirement for ER/LA opioids, they only make up 9% of all opioids prescribed compared to IR opioid analgesics, which make up 91% of all opioids prescribed,” the senators wrote. “Furthermore, prescriptions for IR opioids increased from 164.8 million in 2000 to 234 million in 2009…. If FDA chooses to continue not requiring REMS for IR opioids, we request more information as to its decision to contradict its own advisory committees and data that indicates ‘weak or insufficient evidence’ in determining an increased risk of overdose, addiction, abuse or misuse in ER/LA opioids over IR opioids.”