FDA panel recommends tighter rules for prescribing opioids

BMJ 2013; 346 doi: (Published 14 February 2013) Cite this as: BMJ 2013;346:f1012
  1. Michael McCarthy
  1. 1Seattle

An advisory panel of the US Food and Drug Administration has recommended that the FDA reclassify hydrocodone combination products as schedule II drugs, defined as those having a high potential for abuse and severe threat of dependence. These products include the popular combination of hydrocodone and acetaminophen (paracetamol), such under brands such as Vicodin.

The panel, which met on 24-25 January, voted 19 to 10 in favor of rescheduling. Although such recommendations are considered only advisory, the FDA usually follows its advisory panels’ guidance.

Hydrocodone combination products are currently classified as schedule III drugs, recognizing that they pose a “moderate” risk of dependence. But rules governing the prescription of schedule III drugs are much less strict. Doctors can prescribe several refills at a time and can phone or fax prescriptions to a pharmacy. In the case of schedule II drugs a refill requires a return visit to the physician, and stricter documentation and reporting are needed.

Groups advocating the change argue that the rescheduling is needed to combat the epidemic of prescription drug overdoses, which claims about 15 000 lives a year in the United States, more than the combined number of deaths from cocaine and heroin overdose.1

Andrew Kolodny, president of Physicians for Responsible Opioid Prescribing, said that the change would have a big effect on the number of deaths. “When you talk to doctors treating opioid addiction, they’ll tell you that when someone comes with opioid addiction, whether they are injecting heroin or snorting oxycodone, overwhelmingly their exposure to opioids began with hydrocodone.”

Opponents of the rescheduling said that the change would do little to combat the epidemic and would put a straitjacket on physicians, making it more difficult for patients to obtain drugs that if used wisely are effective at treating pain.

The second hearing in front of FDA officials, held on 7-8 February, was called in response to a citizens’ petition asking for changes to the labeling of all opioids prescribed for non-cancer pain (

Current labels indicate that these drugs are safe and effective for the treatment of “moderate to severe” non-cancer pain, and the labels impose no limit in dosage or duration of treatment.

The petitioners, who included 35 clinicians, researchers, and health officials, argued that scientific studies have not established the effectiveness and safety of long term opioid treatment and that recent research was raising safety concerns, especially when opioids were used over a long term and at higher doses.

The petitioners asked the FDA to strike the term “moderate” from the labeling and to add a suggested maximum of daily dose of 100 mg morphine equivalents and a suggested duration of use of 90 days.

Such changes, said Kolodny, whose organization arranged the petition, would prompt physicians to be more cautious in their use of opioids for non-cancer pain and would prevent drug manufacturers from overstating the benefits and downplaying the risks of opioid analgesics.

The FDA has not said when it might act on the petition or on its advisory panel’s recommendations.


Cite this as: BMJ 2013;346:f1012


  • US Editor’s Choice: Slowing the opioid analgesic overdose epidemic (BMJ 2013;346:f730, doi:10.1136/bmj.f730)


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