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Jan. 25, 2013

Update: "By a 19 to 10 vote, FDA’s Drug Safety and Risk Management Advisory Committee today strongly urged the agency to recommend hydrocodone-containing drugs be moved to more tightly regulated Schedule II under the federal Controlled Substance Act. Because of a dangerous mistake, when the law was passed more than 40 years ago, these drugs were placed in the more lax Schedule III, allowing this powerful narcotic to become the most prescribed drug of any kind in the U.S. Ninety-nine percent of  the world’s manufacture and  use of hydrocodone is in the U.S.  The rest of the world---where the drugs is not allowed at or barely used---will now wonder why took so long for the US to come to its senses and take this step to greatly reduce the future toll after thousands  have already died from its addiction and use." - Dr. Sidney Wolfe, director of Public Citizen's Health Research Group

U.S. Leads With 99 Percent of World’s Hydrocodone Consumption; FDA Should Restrict Its Use

The Narcotic Is Used in 20 Pain Medications

WASHINGTON, D.C. – Ninety-nine percent of the hydrocodone in the world is manufactured and used in the United States – evidence that hydrocodone products are being overprescribed and should be severely restricted in the U.S., Public Citizen told the FDA today.

The FDA is considering whether to make hydrocodone a “schedule II” drug, which would limit the amount a patient could obtain between doctor visits. Rather than get a prescription that provides for five refills (the rule for Schedule III), a patient would get three prescriptions at once from a doctor, fill one each month, then return to the doctor only when the three-month supply was used up.

“The United States is suffering from the world’s worst epidemic of prescription narcotic use, more than half of it being hydrocodone,” said Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, who testified today before the FDA’s Drug Safety and Risk Management Advisory Committee in support of making hydrocodone a schedule II drug. “The reason: It can too easily be prescribed. Requiring doctors to see patients every three months to re-prescribe the drug would dramatically cut down on its misuse.”

The debate comes because of an increase in abuse and overdoses of painkillers in the U.S. According to the U.N.-associated International Narcotics Control Board’s 2011 report, “Narcotic Drugs, ” the U.S. leads the world in consumption per million people of daily doses of all prescription narcotics, with 47,800 doses taken daily. Fifty-five percent of those doses contain hydrocodone. Hydrocodone is found in more than a dozen pain medications, as well as some cough syrups.

According to that report, every year, Americans consume an eye-popping total of 2.6 billion doses a year of hydrocodone, more than 8 doses per person per year, averaged over the whole population. Of the top 100 narcotic-consuming countries, in only one – Canada – do patients take slightly more than 1 percent of the amount of hydrocodone per million people used by U.S. patients, Wolfe said. Hydrocodone is not used in 84 of these 100 top narcotic-prescribing countries.

“More prescription narcotics are prescribed per capita in the United States than anywhere in the world,” Wolfe said. “The fact that patients in other countries manage their pain with a minimal or no use of hydrocodone drugs indicates that the U.S. could move in that direction without any harm to patients.”

To see Wolfe’s presentation, visit http://www.citizen.org/documents/2092.pdf.

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