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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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States And Their Congressmen Battling New Painkiller That Is Easier To Crush And Inject
Some states are restricting the use of the new painkiller Zohydro, "setting up a showdown with the federal government over who gets to decide the best way to protect public health," Michael Ollove reports for Stateline. Rogers (Herald-Leader photo)Though...
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Rogers, Other Drug-caucus Chair File Bill To Reverse Fda's Approval Of New Painkiller; Competing Company Has Alternative
Illustration from PainAndDepression.comU.S. Reps. Hal Rogers of Somerset and Stephen Lynch of Massachusetts have introduced a bill to withdraw federal approval of a new formulation of hydrocodone that is highly addictive and produced in crushable pills,...
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Fda Likely To Make Hydrocodone Painkillers Harder To Prescribe
Prescription painkillers containing hydrocodone should be placed in a more restrictive federal category, a Food and Drug Administration advisory panel of experts voted on Friday. The changes would be an effort to stem the tide of prescription...
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Pure Hydrocodone Pain Pill In Testing; Critics Worry About Abuse
A new pain pill, one more powerful than OxyContin and 10 times stronger than Vicodin, is being tested on patients by four drug companies and could be out as early as 2013. The new medicine, which is a pure form of hydrocodone, has law enforcement in Eastern...
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Prescription Drug Abuse Is An Epidemic Nationwide And In Ky.
Prescription pain medicine overdoses now kill more people in the U.S. than heroin and cocaine combined, with 40 Americans dying every day from painkiller abuse. "This stems from a few irresponsible doctors," said Thomas Frieden, director of the Centers...
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