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FDA recommends reclassifying Vicodin as harder drug

  1. Phungushead
    The Food and Drug Administration is recommending additional restrictions on prescriptions for painkillers, which could affect how patients receive the medications going forward.

    The FDA has proposed reclassifying hydrocodone combination pills, such as Vicodin (which combines hydrocodone with acetaminophen), from a Schedule III drug to a Schedule II drug, which will make the meds harder to obtain.

    "For the millions of American patients experiencing an acute medical need or living with chronic pain, opioids, when prescribed appropriately, can allow patients to manage their pain as well as significantly improve their quality of life," Dr. Janet Woodcock, director for the Center for Drug Evaluation and Research at the FDA, said in a statement posted Thursday afternoon on the agency's website. "However, in recent years, the FDA has become increasingly concerned about the abuse and misuse of opioid products, which have sadly reached epidemic proportions in certain parts of the United States."

    The New York Times first reported the recommendation, which may go into effect as early as next year.

    The recommendation dates back to 2009, when the Drug Enforcement Administration asked government health officials for a recommendation regarding whether to change the pills' classification. In January, an advisory panel of doctors had recommended to the FDA that the agency reclassify the pills to a tougher scheduling class.

    The Controlled Substances Act divides all drugs into five "schedules" based on their accepted medical uses and potential for abuse. Schedule V substances are medical preparations that have the lowest potential for abuse (e.g. Robitussin AC), while Schedule I substances have no "currently accepted medical use in the U.S.," and include heroin, LSD and marijuana.

    Vicodin is currently classified as a Schedule III drug, which means it may lead to moderate or low physical dependence or high psychological dependence. It can currently be refilled up to five times before a patient has to see his doctor again.

    By moving it to Schedule II -- which means it has a high potential for abuse and can lead to severe physical or psychological dependence -- the drugs can only be prescribed in 90-day amounts before a trip to the doctor. Nurses and physician assistants will no longer be able to prescribe the medications.

    Examples of other Schedule II drugs include Adderall, Ritalin, OxyContin, morphine, opium and codeine.

    The FDA said its decision stems from extensive research of scientific literature and reviews of hundreds of public comments solicited by the agency.

    "We anticipate that the National Institute on Drug Abuse (NIDA) will concur with our recommendation," Woodcock said in the statement.

    She told the Times the agency realizes the new restrictions would affect patients, but the public health impact of painkiller abuse had reached a tipping point.

    Nearly three out of four prescription drug overdoses are caused by prescription pain pills, according to the Centers for Disease Control and Prevention, an "unprecedented rise" that parallels a 300 percent increase in the products' sales since 1999.

    Deaths from prescription painkiller overdoses in women increased more than 400 percent since 1999, compared to 265 percent among men.

    In 2010, 2 million people reported using prescription painkillers non-medically -- which includes without a prescription or taking them for the feeling they cause -- for the first time within the last year.

    "These are very difficult tradeoffs that our society has to make," Woodcock told the paper. "The reason we approve these drugs is for people in pain. But we can't ignore the epidemic on the other side."

    October 24, 2013

    Ryan Jaslow
    CBS News
    Image: iStockphoto


  1. BigDiggerNick
    Hydrocodone might be as hard to get as oxycodone now

    The Food and Drug Administration is recommending new restrictions on prescription medicines containing hydrocodone, the highly addictive painkiller that has grown into the most widely prescribed drug in the U.S.

    In a major policy shift, the agency said in an online notice Thursday that hydrocodone-containing drugs should be subject to the same restrictions as other narcotic drugs like oxycodone and morphine.

    The move comes more than a decade after the Drug Enforcement Administration first asked the FDA to reclassify hydrocodone so that it would be subject to the same restrictions as other addictive painkilling drugs. The FDA did not issue a formal announcement about its decision, which has long been sought by many patient advocates, doctors and state and federal lawmakers.

    For decades, hydrocodone has been easier to prescribe, in part because it is only sold in combination pills and formulas with other non-addictive ingredients like aspirin and acetaminophen.

    That ease of access has made it many health care professionals' top choice for treating chronic pain, everything from back pain to arthritis to toothaches.

    In 2011, U.S. doctors wrote more than 131 million prescriptions for hydrocodone, making it the most prescribed drug in the country, according to government figures. The ingredient is found in blockbusters drugs like Vicodin as well as dozens of other generic formulations.

    It also consistently ranks as the first or second most-abused medicine in the U.S. each year, according to the DEA, alongside oxycodone. Both belong to a family of drugs known as opioids, which also includes heroin, codeine and methadone.

    Earlier this year the Centers for Disease Control and Prevention reported that prescription painkiller overdose deaths among women increased about fivefold between 1999 and 2010. Among men, such deaths rose about 3.5-fold. The rise in both death rates is closely tied to a boom in the overall use of prescribed painkillers.

    The FDA has long supported the more lax prescribing classification for hydrocodone, which is also backed by professional societies like the American Medical Association.

    But the agency's top drug regulator, Dr. Janet Woodcock, said in a statement Thursday: "The FDA has become increasingly concerned about the abuse and misuse of opioid products, which have sadly reached epidemic proportions in certain parts of the United States."

    The FDA says it will formally request in early December that hydrocodone be rescheduled as a Schedule II drug, limiting which kinds of medical professionals can write a prescription and how many times it can be refilled.

    The Controlled Substances Act, passed in 1970, put hydrocodone drugs in the Schedule III class, which is subject to fewer controls. Under that classification, a prescription for Vicodin can be refilled five times before the patient has to see a physician again. If the drug is reclassified to Schedule II, patients will only be able to receive one 90-day prescription, similar to drugs like OxyContin. The drug could also not be prescribed by nurses and physician assistants.

    The FDA's request for reclassification must be approved by officials in other agencies within the Department of Health and Human Services.

    News of the FDA decision was applauded by lawmakers from states that have been plagued by prescription drug abuse, many who have been prodding the agency to take action for months.

    "Today was a tremendous step forward in fighting the prescription drug abuse epidemic that has ravaged West Virginia and our country," said Democratic Sen. Joe Manchin, in a statement. "Rescheduling hydrocodone from a Schedule III to a Schedule II drug will help prevent these highly addictive drugs from getting into the wrong hands and devastating families and communities

    Sen. Charles Schumer of New York noted that the FDA's own expert panel recommended the reclassification more than nine months ago.

    "Each day that passes means rising abuse, and even death, at the hands of hydrocodone-based drugs," Schumer said in a statement.

    Still, Thursday's action immediately sparked criticism from some professional groups that said that the tighter restrictions could have unintended consequences, such as burdening health care workers and patients.

    "The FDA's reported decision will likely pose significant hardships for many patients and delay relief for vulnerable patients with legitimate chronic pain, especially those in nursing home and long-term care," said Kevin Schweers, a spokesman for the National Community Pharmacists Association.

    October 25th 2013

    Mathew Perrone
    The Christian Science Monitor

    I thought this was worth sharing. This would suck because then it would be harder to get it and you'd have to keep getting new prescriptions. What are your thoughts on this? Should it be reclassified?
  2. Pseudovoyager
    FDA aims to tighten control of hydrocodone

    (CNN) - FDA aims to tighten control of hydrocodone

    One person dies every 19 minutes from a prescription drug overdose in the United States.

    In an effort to combat "misuse and abuse," the Food and Drug Administration is proposing new restrictions that would change regulations for some of the most commonly prescribed narcotic painkillers on the market.

    The FDA's latest proposal would specifically affect hydrocodone combination pills, also known as opioids, which combine hydrocodone with less potent painkillers such as acetaminophen. One example is the drug Vicodin.

    Currently labeled as Schedule III drugs, these opioids would, if the reclassification proposal is accepted, be labeled as Schedule II.

    This means patients would have to have a written prescription from a doctor -- instead of a prescription submitted orally over the phone -- to access the drugs. And refills would be prohibited; patients would have to check in with the doctor to get another prescription.

    A Schedule II classification would also put manufacturing quotas in place for these hydrocodone products. Pure hydrocodone is already a Schedule II substance.

    Drugs are categorized into one of five "schedules" by the Drug Enforcement Administration based on "whether they have a currently accepted medical use in treatment in the United States, their relative abuse potential and their likelihood of causing dependence when abused." Other drugs, such as Adderall and morphine, are also labeled as Schedule II.

    "When you wonder why your dentist gives you 40 hydrocodone for a toothache, or your knee doctor prescribes far more than he should, that's because they're under the impression that it's not addictive as Percocet," Dr. Andrew Kolodny, president of Physicians for Responsible Opioid Prescribing, told CNN in January when an FDA advisory panel first urged the administration to recommend tighter restrictions.

    "That's completely false."

    In an online statement posted Thursday, the FDA said it "has become increasingly concerned about the abuse and misuse of opioid products, which have sadly reached epidemic proportions in certain parts of the United States."

    Approximately 80% of the world's pain pills are consumed in the United States, according to 2011 congressional testimony from the American Society of Interventional Pain Physicians. Since 1999, sales of prescription painkillers in the United States have quadrupled. So have the number of fatal poisonings from prescription painkillers. Almost twice as many people abuse prescription drugs as the number of people abusing cocaine, heroin, hallucinogens and inhalants combined, the DEA says.

    Report: States failing to curb prescription abuse

    "Truth is, it is easier for a doctor to write a prescription than to explore other effective options to combat pain," CNN chief medical correspondent Dr. Sanjay Gupta wrote in an editorial. "And it is easier for patients to take those prescription pills than to search for alternatives themselves. Both those things must absolutely change."

    The FDA argues it did not come to its decision lightly, saying it conducted a "thorough and careful analysis of extensive scientific literature, review of hundreds of public comments on the issue, and several public meetings" in an effort to ensure that future drugs are "properly prescribed and appropriately used by the patients who need them most."

    The FDA's proposal is scheduled to be submitted to the Department of Health and Human Services by early December, but the DEA has the final decision on whether to reclassify the drugs. A spokesman for the DEA told CNN it would be premature to speak about the FDA's recommendation at this time.

    In September, the FDA took another step to reduce painkiller abuse with new labeling regulations, which are set to go into effect at the end of this year. Currently, the labels on the drugs say they are for "the relief of moderate to severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time." The new labels will say the drugs should be used only when "alternative treatment options are inadequate."

    The FDA said it hopes the changes will result in a larger conversation about pain management between patients and doctors.

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