Tighter rules on hydrocodone products recommended
WASHINGTON -- Hydrocodone painkillers, the most popular pharmacy drugs in the United States, should be placed under the same tighter restrictions as oxycodone and morphine because of the potential for abuse, a government advisory panel recommended Friday.
By a 19-10 vote, the panel urged the Food and Drug Administration to expand limits on hydrocodone-combination pills such as Vicodin as well as cough suppressants containing hydrocodone. The FDA, which in 2008 denied a request by the Drug Enforcement Administration for stricter regulation, must decide whether to follow the panel's recommendation.
The DEA urged limiting prescriptions to a 90-day supply instead of the current five refills within six months, and for stripping dentists, physician assistants and nurse practitioners of authority to prescribe the pills.
About 131 million hydrocodone products were dispensed in 2011, more than double the number for oxycodone pills, according to an FDA staff report.
"I'm appalled to see that hydrocodone is the most prescribed drug in the United States, and that has to be something very wrong with our health care system and society for this to happen," said Maria Suarez-Almazor, a panelist and a professor of internal medicine at the University of Texas MD Anderson Cancer Center in Houston, who favored more restrictions.
Hydrocodone combinations, which join the main ingredient with less-potent painkillers such as acetaminophen or ibuprofen, are considered a Schedule III controlled substance, the third-highest level on a five-stage scale that takes into account addiction risk.
Pure hydrocodone already is one class higher at Schedule II and, as a result, has more restrictions on sales.
"The potential for abuse of hydrocodone-combo products is comparable with other drugs in Schedule II," said William Cooper, a professor of pediatrics and preventive medicine at Vanderbilt University in Nashville, Tenn.
Those who opposed tighter restrictions cited legitimate medical needs for opioids as well as concern that illicit drug use may rise if patients can't get prescription pain relievers.
Greater restrictions on hydrocodone could have a chilling effect on doctors' willingness to provide needed hydrocodone, said Edward Michna, director of the Pain Trials Center at Brigham and Women's Hospital in Chestnut Hill, Mass. "It's all about balance," he said.