FDA panel votes for more restrictions on hydrocodone products

An FDA advisory committee voted to move hydrocodone combination drugs from Schedule III into the more restrictive Schedule II category of controlled substances in late January.

“Hydrocodone-containing products including hydocrodone combination products and hydrocodone used as an antitussive should be moved from Schedule III to Schedule II,” said panelist Mary Ellen Olsbrisch, PhD, professor of psychiatry and surgery, and clinical psychologist, department of psychiatry, Virginia Commonwealth University, Richmond, Va.

According to Olsbrisch, the available scientific evidence shows that hydrocodone produces drug dependence of the same severity as morphine and oxycodone, drugs that are on Schedule II because of the severity of drug dependence that they can create.  

“The panel was concerned about an epidemic of addiction to opiate pain medications in this country, about morbidity and mortality connected with this epidemic, and about hydrocodone's role as a ‘gateway’ drug,” she explained.  

FDA still must decide whether to accept the panel’s recommendation.

“If it does, chronic pain patients who are on long-term treatment with hydrocodone products probably will have to see their physicians more frequently and will not be able to receive longer-term prescriptions with multiple refills,” said Olsbrisch.

According to AddictionWithdrawal.com, hydrocodone is used in more than 200 different prescription medications, including some cough suppressants. Most cases of addiction are among women between aged 20 and 40 years. In addition, cases of hydrocodone addiction are growing among teens due to the ease of availability.