FDA to Consider Tighter Regulations for Hydrocodone

The Food and Drug Administration (FDA) will soon consider whether prescription painkillers containing hydrocodone should be more tightly regulated, as the Drug Enforcement Administration (DEA) has urged, USA Today reports.

A committee of the FDA will meet January 24 and 25 to consider the DEA’s request. The committee will assess the DEA’s evidence, hear comments from the public, and then vote on its recommendation to the FDA commissioner and the Department of Health and Human Services, according to the newspaper.

Emergency room visits related to hydrocodone, the key ingredient in Vicodin and other painkillers, have soared since 2000. Vicodin, which also contains acetaminophen, is subject to fewer regulations than pure hydrocodone.

For almost a decade, the DEA has called for stricter regulation of Vicodin, in order to reduce abuse of the drug, the article notes. The DEA wants to change the way drugs that combine hydrocodone with other products are classified, to require patients to have more interaction with doctors in order to obtain prescriptions for them. The FDA and DEA have repeatedly passed information back and forth about hydrocodone, without making any final decisions about the drug.

The DEA classifies drugs on a five-stage scale, which takes into account the potential for addiction. Currently, hydrocodone is considered by the DEA to be a Schedule II controlled substance, the second-highest level. Hydrocodone combinations, such as Vicodin, are Schedule III, and therefore have fewer restrictions on sales.

Schedule II drugs must be locked up at pharmacies. Physicians can only prescribe one bottle at a time and patients must have an original prescription in order to obtain the medication. Schedule III drugs can be refilled up to six times without visiting a doctor, who can phone or fax in a prescription to the pharmacy.