January 26, 2013
Advisory Panel Wants FDA To Place Tighter Controls On Hydrocodone
redOrbit Staff & Wire Reports - Your Universe Online
A panel of medical experts is advising the US Food and Drug Administration (FDA) to tighten restrictions on painkillers that contain the substance hydrocodone — a move intended to make it more difficult to prescribe and, ideally, help to curb abuse of the addictive substance.
According to Reuters, the panel voted 19-10 in favor of reclassifying all medications containing less than 15 milligrams of hydrocodone, which include Vicodin, as Schedule II controlled substances — a group which also includes opioid painkillers such as oxycodone and morphine.
Currently, hydrocodone is listed as a Schedule III controlled substance, which is said to have “moderate abuse potential.”
However, there were 131 million prescriptions for hydrocodone written in 2010, according to statistics from health care information firm IMS Health.
That figure “far outpaces the medical need for the drug,” according to Dr. Andrew Kolodny, president of Physicians for Responsible Opioid Prescribing (PROP).
“Most doctors are under the impression that Vicodin (whose main ingredient is hydrocodone) is less addictive than other prescription painkillers,” Dr. Kolodny said. “That's completely false“¦ We've had a medical community that has been massively overprescribing the drug. There is very little difference between a hydrocodone molecule and a heroin molecule. We need doctors to prescribe much more cautiously.”
Americans consume 99 percent of the hydrocodone produced worldwide, and as the most commonly prescribed painkiller in the US, prescriptions for it outpace the top antibiotic and blood pressure medications, wrote Lisa Girion of the Los Angeles Times.
Similarly, CDC statistics show trips to the emergency room resulting directly from the misuse of prescription painkillers like hydrocodone had more than doubled from 2004 to 2009.
“The recommendation, which the drug agency is likely to follow, would limit access to the drugs by making them harder to prescribe, a major policy change that advocates said could help ease the growing problem of addiction to painkillers, which exploded in the late 1990s and continues to strike hard in communities from Appalachia and the Midwest to New England,” observed Sabrina Tavernise of the New York Times.
However, even though painkillers “now take the lives of more Americans than heroin and cocaine combined,” the verdict reached by the advisory panel “was far from unanimous,” she noted, “with some opponents expressing skepticism that the change would do much to combat abuse.” Those critics pointed out that oxycodone, “another highly abused painkiller“¦ has been in the more restrictive category since it first came on the market,” Tavernise added. “They also said the change could create unfair obstacles for patients in chronic pain.”
If the FDA enacts the recommended changes, it would mean patients taking hydrocodone-based painkillers would be required to have a written prescription to obtain the medications — faxed or called-in prescriptions are prohibited for Schedule II drugs. Furthermore, pharmacists would be forced to store the medication in a special vault, and refills without new prescriptions would no longer be permitted.