FDA Advisers Reject Purdue’s New Opioid Painkiller
An outside panel of advisers to FDA last week voted 23-1 against approval of Purdue Pharma's new proposed opioid painkiller, citing concerns of overdose risks. Panelists noted an issue with the drug that delays its absorption when taken with food. According to the panelists, the issue poses a safety risk because individuals might not follow orders to take the medication on an empty stomach. Instead, the panelists said individuals could possibly take multiple doses of the medication when they do not experience prompt pain relief.
- "FDA Panel Recommends Not Approving Purdue's Opioid Painkiller" (Nathan, Reuters, 9/10).
- "FDA Panel Votes Against Painkiller From OxyContin Maker" (AP/Sacramento Bee, 9/10).