Friday, October 25, 2013

FDA wants to limit number of hydrocodone refills available without another doctor visit; approves pure version of drug

"The Food and Drug Administration on Thursday recommended tighter controls on how doctors prescribe the most commonly used narcotic painkillers, changes that are expected to take place as early as next year," Barry Meier reports for The New York Times. "Drugs at issue contain a combination of hydrocodone and an over-the-counter painkiller like acetaminophen or aspirin and are sold either as generics or under brand names like Vicodin or Lortab." (Associated Press photo by Toby Talbot)

"Doctors use the medications to treat pain from injuries, arthritis, dental extractions and other problems," Meier writes. "The change would reduce the number of refills patients could get before going back to see their doctor. Patients would also be required to take a prescription to a pharmacy, rather than have a doctor call it in. The new regulations would reduce by half, to 90 days, the supply of the drug a patient could obtain without a new prescription."

On Friday, the FDA announced it had approved a stronger version of hydrocodone, Zohydro ER, for patients who require 24-hour, long-term pain medication. "The new version is the first pure hydrocodone drug approved in the U.S.," ABC News reports. "Hydrocodone is currently sold in combination pills like Vicodin to treat pain from injuries, surgery, arthritis and migraines." Activists against prescription-drug abuse criticized the decision.

U.S. Rep. Hal Rogers of Kentucky's 5th District "said on Friday that top FDA officials had recently assured him they would only approve new opioids like Zohydro if they were marketed in formulations intended to deter abuse," Meier and Eric Lipton report. "OxyContin is now formulated that way, but Zohydro, which is contains hydrocodone without acetaminophen, is not. Its producer, Zogenix, says it will closely monitor use of the drug." Rogers told the Times, “It is like the original OxyContin, so that is real problematical.”        

More than 6.1 million Americans abuse prescription pills, and last year there were 22,133 prescription drug deaths. The problem is most rampant in Central Appalachia, including Eastern Kentucky.

In 2011, about 131 million prescriptions for 47 million patients, or about five billion pills, were written for medications containing hydrocodone, Meier notes. "Prescription drugs account for about three-quarters of all drug overdose deaths in the United States, with the number of deaths from narcotic painkillers, or opioids, quadrupling since 1999, according to federal data." (Read more)

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