FDA Denies Public Citizen Tramadol Petition

FDA has denied a Public Citizen 11/6/2019 petition asking that it and the Drug Enforcement Administration (DEA) open proceedings to reschedule tramadol from Schedule 4 of the Controlled Substances Act to Schedule 2 “because the drug has a high potential for abuse, with use potentially leading to severe psychological or physical dependence, and is considered dangerous.” The denial letter says that the DEA is the federal agency that takes scheduling actions under the Controlled Substances Act and FDA will communicate with DEA “as appropriate.”

“Although we deny the petition’s request to initiate proceedings to reschedule this substance,” FDA says, “we are aware of some of the concerns raised in the petition and have taken action to address such concerns…. We will continue to monitor the safety of tramadol and may take additional action, if necessary.”