In a move to stem the epidemic of prescription drug deaths, an advisory panel to the FDA recommends that the agency reclassify hydrocodone, the active ingredient in Vicodin, as a Schedule II narcotic.
In a move to stem the epidemic of prescription drug deaths, a federal advisory panel has recommended tighter controls on a narcotic painkiller best known by the brand name Vicodin. It is the nation’s most widely prescribed drug.
By a 19-to-10 vote, an advisory panel to the U.S. Food and Drug Administration recommended Friday that the agency reclassify hydrocodone, the active ingredient in Vicodin, as a Schedule II narcotic, placing it in the same category as other widely abused medications, including OxyContin and fentanyl.
If the FDA approves the change, patients would be able to get fewer hydrocodone pills at one time, and there would be more restrictions on refills. In addition, pharmacies would have to follow stricter procedures for handling and storing the drug.
Schedule II is the government’s most restrictive category for pharmaceuticals with accepted medical uses. Hydrocodone is now listed on Schedule III.
The United States consumes 99% of the hydrocodone produced worldwide, and doctors write more prescriptions for it than for the leading antibiotic and hypertension medications.
Prescription drugs — primarily narcotic painkillers such as hydrocodone — cause or contribute to more deaths than heroin and cocaine combined. As a result, drug fatalities have surpassed deaths from motor vehicle crashes, long the leading cause of accidental death in this country.
A Los Angeles Times analysis of 3,733 prescription drug-related fatalities in Southern California from 2006 through 2011 found that hydrocodone was involved in 945 of the deaths, more than any other prescription medication.
Doctors have prescribed hydrocodone with few restrictions since it was introduced four decades ago. Because of the perception that it is less risky than other narcotic painkillers, it is widely prescribed by general practitioners and dentists.
Yet drug enforcement officials have long complained that hydrocodone was highly addictive and widely abused.
For years, the FDA resisted tightening the rules on its use out of concern that doing so would make it more difficult for patients with legitimate pain to obtain the drug. The U.S. Drug Enforcement Administration asked the agency to reconsider in light of the drug’s widespread availability on the black market.
Earlier this week, the American Academy of Pain Medicine sent the FDA advisory panel a letter saying that although it had some concern that tighter rules could curtail legitimate prescribing, it did not oppose moving hydrocodone to Schedule II.
Morgan Liscinsky, a spokeswoman for the FDA, said she could not say when the agency would act on the recommendation.
In seeking to stem the increase in fatal drug overdoses, authorities have focused on how addicts and drug dealers obtain prescription narcotics illegally, such as by stealing from pharmacies or relatives’ medicine cabinets. Recent articles in The Times, however, reported that many overdoses stem from drugs prescribed for the deceased by a doctor.
In nearly half of the prescription drug fatalities in four Southern California counties, medications prescribed by physicians caused or contributed to the death, according to a Times analysis of coroners’ records.
Seventy-one doctors, a tiny fraction of all practicing physicians in the four counties, were associated with a disproportionate number of deaths.
In response to the articles, the Medical Board of California has appealed to the public to report instances of excessive prescribing, and legislative leaders, including the president of the California Senate, have promised to give the board more investigators and greater authority to stop reckless prescribing.