WASHINGTON — The Food and Drug Administration intends to recommend to the Department of Health and Human Services that hydrocodone combination products like Vicodin be reclassified to a more restrictive schedule.

“FDA has been challenged with determining how to balance the need to ensure continued access to those patients who rely on continuous pain relief while addressing the ongoing concerns about abuse and misuse,” said Janet Woodcock, director of the Center for Drug Evaluation and Research, in a statement.


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Under the Controlled Substances Act controlled substances are organized in to one of five schedules based on the potential for abuse and medical use.

FDA plans to submit its formal recommendation to HHS by early December that hydrocodone products be moved from Schedule III (drugs deemed to have less potential for abuse) to Schedule II (drugs with high potential for abuse).

“We anticipate that the National Institute on Drug Abuse (NIDA) will concur with our recommendation,” Woodock said.

Read more: FDA Requires Opioid Label Changes

The FDA’s plan comes weeks after it announced required labeling changes to oxycodone and other extended-release and long-acting opioid analgesics, which may reduce the number of patients for whom these painkillers are appropriately prescribed.

FDA also requires that the box warning on extended-release and long-acting opioid analgesics place greater emphasis on the risks of misuse, abuse, addiction, overdose and death.

“FDA has decided to change the labeling to help prescribers better understand the risks of prescribing extended-release long-acting opioid analgesics and to more clearly describe the patient population in whom these drugs should be used,” said FDA Commissioner Margaret Hamburg during a press conference, last month.

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