The United States Food and Drug Administration (FDA) is planning to impose a new restriction on prescription medications that contain hydrocodone, which are widely prescribed to address pain.

FDA Hydrocodone

Dr. Woodcock recommended the reclassification

Dr. Janet Woodcock, director of Center for Drug Evaluation and Research recommended the reclassification of hydrocodone after carefully evaluating and weighing the appropriate use of opioid analgesic products over the past several years.

She pointed out that opioid analgesic products, when prescribed appropriately, improve the quality of life of millions of people with acute medical needs, or those living with chronic pain. However, the FDA has become increasingly concerned with the abuse and misuse of opioid products in recent years. According to Dr. Woodcock, the abuse has reached epidemic proportions in some parts of the United States.

Dr. Woodcock is planning to submit a recommendation to the Department of Health and Human Services (HHS) to reclassify hydrocodone-containing medications to a different and more restrictive schedule.

The Drug Enforcement Administration (DEA) proposed the reclassification of hydrocodone-containing products such as Vicodin to a stricter schedule to increase the control of such products in 2009.

FDA will submit its formal proposal to HHS

Dr. Woodcock said, “Due to the unique history of this issue and the tremendous amount of public interest, we are announcing the agency’s intent to recommend to HHS that hydrocodone combination products should be reclassified to a different and more restrictive schedule. This determination comes after a thorough and careful analysis of extensive scientific literature, review of hundreds of public comments on the issue, and several public meetings, during which we received input from a wide range of stakeholders, including patients, health care providers, outside experts, and other government entities.”

The FDA will submit its formal proposal to HHS to reclassify hydrocodone combination products into Schedule II. The agency expects that the National Institute of Drug Abuse (NIDA) will support its recommendation. The DEA will make the final decision as to the appropriate scheduling of the products.

Hydrocodone is the most prescribed medicine

Hydrocodone is the most prescribed medicine in the United States. Physicians wrote 131 million prescriptions for hydrocodone in 2011. The DEA reported that hydrocodone and oxycodone – known as opiods – are the most abused medication in the country.

The Centers for Disease Control and Prevention reported that deaths among women caused by overdose in prescription painkillers increased 5x and 3.5x among men from 1999 to 2010.