FDA recommends schedule II for hydrocodone combinations


The Food and Drug Administration will recommend that products containing the narcotic hydrocodone be reclassified from Schedule III drugs to the more restrictive Schedule II, the agency announced.

This major policy shift would affect access to widely used drugs that combine hydrocodone with other medications such as acetaminophen in brand names like Vicodin, Norco, or Lortab.

The FDA’s decision comes out of years of controversy over epidemic-scale abuse and misuse of opioid products in some parts of the country and the need to balance safety with continued access to the drugs for patients who rely on them for continuous pain relief, said Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research, in a statement released online.

The move also follows a 19-10 vote by the FDA’s Drug Safety and Risk Management Advisory Committee in January 2013 calling for hydrocodone combination products to be reclassified as Schedule II, as well as requests from the U.S. Drug Enforcement Administration for this action.

Under the Controlled Substances Act, Schedule II drugs usually require handwritten prescriptions with no refills, among other restrictions, while Schedule III allows written or oral prescribing and five refills within 6 months.

The FDA plans to submit formal recommendations by early December to the U.S. Department of Health and Human Services to reclassify hydrocodone combination products into Schedule II, and the agency expects that the National Institute on Drug Abuse will agree with the recommendations, which will start a process leading to a final decision by the Drug Enforcement Administration.

This is an "extremely complex" issue and a "major change" that has at least the potential to benefit patients, Dr. Adrian G. Bartoli said in a phone interview.

Hydrocodone is probably twice as potent as morphine and as potent and addictive as any Schedule II drugs, said Dr. Bartoli, a pain management specialist practicing in San Francisco. Hydrocodone has remained in Schedule III largely for historical reasons, but if it was a new drug being classified today, "it would unquestionably be a Schedule II medication," he said.

Many clinicians such as internists or surgeons will prescribe hydrocodone combination products less often if it becomes a Schedule II drug because they’ll lose the convenience of oral prescribing and refills, he predicted. The change won’t affect Dr. Bartoli’s practice because "I already see patients on a regular basis and write out a prescription for them," he said. Approximately 40% of hydrocodone combination analgesics are prescribed by primary care practitioners, according to the FDA.

Some patients who lose access to hydrocodone combination products may turn to emergency departments and urgent care centers more often for help with their pain, Dr. Bartoli predicted.

On the other hand, while there is nothing really equivalent to hydrocodone in Schedule III or IV drugs, clinicians who turn away from prescribing hydrocodone combination products may fill that vacuum with medications like tramadol, which is not a scheduled substance in most states, or buprenorphine, which falls under Schedule III, he said. Right now, those medications are on the fringe of pain management. "They’re actually excellent medications, but they’re not prescribed that often," he said.*

Dr. Janet Woodcock

Whether this change would be good or bad is hard to say, he added. "Generally in my experience those medications may have less addictive potential. I think that’s a good thing for patients and overall may be an improvement in the way that pain management is being delivered right now."

Hydrocodone alone already is a Schedule II drug, but there is no single-ingredient hydrocodone product available. There are 81 products that combine hydrocodone with acetaminophen or ibuprofen and 12 cough suppressants that combine hydrocodone with chlorpheniramine, homatropine, or pseudoephedrine, according to the FDA. In 2011, there were about 131 million prescriptions for combination hydrocodone analgesic products, compared with 35 million for combinations containing oxycodone (a Schedule II drug), according to national prescription data cited by the FDA.

Dr. Bartoli has been a consultant to Purdue Pharma and to Vertical Pharmaceuticals, both of which market pain management medications.**

*This paragraph contains a correction. Dr. Bartoli was speaking of tramadol rather than trazodone.

**This story was updated 10/28/13.

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