FDA calls for reclassification of codeine combo medications to stricter schedules

The US Food and Drug Administration has indicated that it wants to see the classification of codeine-containing medications.

Over the past several years, the FDA has been evaluating the appropriate use of opioid analgesic drug products. It has become increasingly concerned about the abuse and misuse of opioid products, which it said has reached “epidemic proportions” in certain parts of the USA. The 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.

In 2009, the US Drug Enforcement Administration (DEA) asked the US Department of Health and Human Services (HHS) for a recommendation regarding whether to change the schedule for hydrocodone combination products, such as AbbVie's (NYSE: ABBV) Vicodin (hydrocodone/acetaminophen). The proposed change was from Schedule III to Schedule II, which would increase the controls on these products.