The U.S. Food and Drug Administration is planning tighter restrictions on drugs that contain hydrocodone, an opioid widely used in potentially addictive pain medications such as Vicodin.
Hydrocodone products are currently classified as Schedule III controlled substances. Under the FDA plan they would be reclassified as Schedule II products, making them harder to obtain for both addicts and legitimate pain patients.
The agency said it would submit a plan for rescheduling later this year to the Department of Health and Human Services (HHS) and the Drug Enforcement Agency (DEA).
“In recent years, the FDA has become increasingly concerned about the abuse and misuse of opioid products, which have sadly reached epidemic proportions in certain parts of the United States,” FDA commissioner Janet Woodcock said in a statement.
“By early December, FDA plans to submit our formal recommendation package to HHS to reclassify hydrocodone combination products into Schedule II. We anticipate that the National Institute on Drug Abuse (NIDA) will concur with our recommendation. This will begin a process that will lead to a final decision by the DEA on the appropriate scheduling of these products.”
The rescheduling would affect dozens of pain medications that contain hydrocodone, including Vicodin, Lortab and Norco. A complete list is available here. Typically in these products, the hydrocodone is combined with either aspirin or acetaminophen.
“While the value of and access to these drugs has been a consistent source of public debate, 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,” Woodcock said.
Patients must present a written prescription to the pharmacist for a Schedule II drug and physicians are not allowed to call in a prescription to the pharmacy. Schedule II drugs are limited to a 90-day supply, after which patients must visit their doctor to get a new written prescription. Pharmacists are not allowed to change the dosage, formulation or quantity prescribed of Schedule II drugs.
In January, an FDA advisory panel voted 19 to 10 to reclassify hydrocodone products. The FDA usually follows the recommendations of its advisory panels.
A bipartisan group of lawmakers has also been urging the FDA to reclassify hydrocodone.
“Rescheduling hydrocodone from a Schedule III to a Schedule II drug will help prevent these highly addictive drugs from getting into the wrong hands and devastating families and communities,” said Sen. Joe Manchin of West Virginia.
“I am also extremely grateful that the Food and Drug Administration has finally implemented its own advisory committee’s recommendations to reclassify these addictive drugs. The agency has just saved hundreds of thousands of lives.”
Hydrocodone is the most widely prescribed drug in the U.S. Over 130 million prescriptions were filled for Vicodin alone in 2010.
Overdoses from painkillers such as hydrocodone now take the lives of more than 15,000 Americans each year, more than heroin and cocaine combined.