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FDA Recommends Tighter Regulations for Prescribing Hydrocodone Products


The Food and Drug Administration (FDA) has recommended tighter restrictions for products containing hydrocodone and other painkillers such as acetaminophen or aspirin. These combination products include Vicodin and Lortab.

Currently, patients can refill prescriptions for hydrocodone products five times over a six-month period before they need a new prescription. Under the new FDA regulations, patients will only be able to receive a 90-day supply of the medication without a new prescription. According to federal data, most patients only take the drugs for about two weeks, creating the potential for extra pills to be sold or taken by teens who find them in the medicine cabinet.

The new rules will also require patients to take a prescription to a pharmacy, instead of having a doctor call it in.

These changes are expected to take place as early as next year, The New York Times reports. They first must be approved by the Department of Health and Human Services and adopted by the Drug Enforcement Administration (DEA), which has long advocated for stronger regulations for prescribing hydrocodone products.

The FDA rules reclassify hydrocodone-containing products from Schedule III drugs to the more restrictive Schedule II drugs, which are medications with the highest potential for abuse that can be legally prescribed, including oxycodone.

Until now, the FDA has said further restricting hydrocodone-containing products would make it more difficult for patients in pain to obtain them. The American Medical Association and other doctors’ groups and pharmacy organizations have opposed tighter restrictions.

Dr. Janet Woodcock, Director of the FDA’s Center for Drug Evaluation and Research, said while the new rules would affect patients, the agency had to consider the impact of prescription drug abuse. “These are very difficult trade-offs that our society has to make,” she told the newspaper. “The reason we approve these drugs is for people in pain. But we can’t ignore the epidemic on the other side.”

9 Responses to this article

  1. Fred Mertz / September 13, 2014 at 2:19 am

    And yet a bottles of Vodka, Scotch, Bourbon, Whiskey, Beer and Everclear Alcohol is still available of the counter Legally in unlimited amounts,
    How many people on the highways are killed by drunk drivers vs.people high on pharmacy drugs ???
    How many people go to rehab for drug vs. alcohol rehab ???
    Cigarettes can kill you according to the FDA and yet the Fed. Govt. still cashes billions in Tax Checks from the sale of Cigarettes everyday. The same is true for the Taxes collected on Alcohol each day and yet it’s still legal ???
    Talk about hypocrites !!!
    I bet there is not one Congressman that can get any pharmacy drug they want without worrying about the rules and regulations !!!
    Just like Celebrities that have Doctors and Lawyers on retainers to give them anything they want in whatever quanities they want and the Doctors very seldom get prosecuted !!!!

  2. Susan / September 7, 2014 at 1:48 pm

    I agree with J. Martin. As someone who lives with chronic pain thanks to multiple orthopedic conditions that cannot be corrected, taking a responsible dose of hydrocodone is what I have to do. I make sure to take less than what I am prescribed because I don’t want to become addicted, and I follow the laws for this medication as do the majority of patients who need it. So thanks to someone like Dr. Skip above who apparently abused his privileges as a physician, I have to suffer the consequences. Maybe alcohol should be banned and strictly regulated too; because people become alcoholics and die every day due to the repercussions of it. I’m not looking forward to the many extra Dr visits and resulting copays that I will encounter now just to say “Hi, yes I’m still in pain and not an addict.”

    • Fred Mertz / September 13, 2014 at 2:34 am

      Patients that NEED the Pain Medications for medical conditions are being discriminated against because of the abuse of these drugs by drug addicts/celebrities/athletes/rich kids/ doctors and etc.
      I have taken hydrocodone for a chronic ruptured disc condition for years responsible and neither I nor my Doctor have EVER had a problem with the 3 per day/90 per month !!!
      I have know medical drug addicts that when they are cut off, they just resort to some other illegal drugs that the obtain on the streets or buy their pain killers of choice at the Liguor Stores !!!
      Maybe the ones that are charged and it’s proven that they purposefully abuse these drugs, they should be prohibited from EVER having the drugs prescribed for them again !!!
      Abuse the drugs, go to rehab., abuse the drugs go to rehad., abuse the drugs and go to rehab and etc., etc., etc. and yet it’s the Patients that NEED the Drugs legitimately that are the ones that wind up paying the consequences !!!
      Maybe ONE STRIKE and their OUT should be the Policy !!!

  3. Avid Flyer / August 28, 2014 at 9:42 pm

    This law has been in effect for over two years now, it’s not new but what is new is the attack on people who being put in the same category as people on Heroin the fact is heroin is on the up swing and is cheep, this drug went from 50 cents a pill to over a dollar a pill not to mention that you have to see your doctor almost every month, as a disabled vet who was crushed in the upper body and both knees broken it saddens me that the FDA would allow pot and not this. The government is gone overboard on restricting access to the drug for those in need, and in fact pursue doctors who prescribe it. I know on a company that supposedly lost 10,000 of these pills and put them in dire legal straights and it ended up being a clerical error and cost 10 people their jobs/ career’s.

  4. Donna Wells / August 22, 2014 at 9:12 am

    My spouse & I have been on some type of pain medication for years due to chronic pain. We have never used more than the prescribed dose; often using less. I agree with these new rules and am willing to be inconvenienced by them if it somehow saves lives. My fear is that most doctors will just stop prescribing them to avoid drug seeking patients. Then what will people like us do? We already drive for 2 hours each way not to lose our current primary care doctor. When he retires; I fear for our health care period.

  5. John Hande / July 15, 2014 at 3:34 pm

    As an arthritis patient I was taking aprox. 1 7.5/325 hydrocodone/apap daily.
    My orthopedist retired. It seems that his replacement and my primary physician both seem afraid to prescribe this medication.

    I believe that the FDA has done a great disservice to people like myself who use these drugs as a tool to control chronic pain.

  6. Skip Sviokla MD ABAM / October 25, 2013 at 11:52 am

    As a practicing physician who had his license revoked in California in 1999, I was very pleased to see Hydrocodone addressed specifically as noted in this article. I had been taking 150 Vicodin ES a day for the last 40 days before California caught up with me and saved my life. (I did not think so at the time!) The changes considered above are a good start. The drug is dangerous. Skip Sviokla MD ABAM (author- From Harvard to Hell and Back)

    • J Martin / August 22, 2014 at 8:58 am

      Well Dr., you are one of the few out of the many misusing and abusing this type of medication that make it a nightmare for the many patients that need this medication just to try to get through the day and have a decent quality of life. I have a major medical problem that causes severe chronic pain, it is not fatal, and over 25 surgeries has only made it worse. Why is it when I am a law abiding citizen, as are most chronic pain patients, that the small minority of people that don’t follow the law make my life and many others a living hell. Again, thank you very much for making it next to impossible for the law abiding very sick patients to get the medication they need.

      • Gina S / September 7, 2014 at 11:01 am

        Rah-Rah to you J Martin! I’m in the same situation with pain and have been for 15 years. Most of us have very high medical insurance deductibles which means we have to pay hundreds of dollars each time we’re required to visit our doctors which also means we’ll all be doing that EACH MONTH if all these new laws go through ~

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