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FDA to Consider Tighter Regulations for Hydrocodone


The Food and Drug Administration (FDA) will soon consider whether prescription painkillers containing hydrocodone should be more tightly regulated, as the Drug Enforcement Administration (DEA) has urged, USA Today reports.

A committee of the FDA will meet January 24 and 25 to consider the DEA’s request. The committee will assess the DEA’s evidence, hear comments from the public, and then vote on its recommendation to the FDA commissioner and the Department of Health and Human Services, according to the newspaper.

Emergency room visits related to hydrocodone, the key ingredient in Vicodin and other painkillers, have soared since 2000. Vicodin, which also contains acetaminophen, is subject to fewer regulations than pure hydrocodone.

For almost a decade, the DEA has called for stricter regulation of Vicodin, in order to reduce abuse of the drug, the article notes. The DEA wants to change the way drugs that combine hydrocodone with other products are classified, to require patients to have more interaction with doctors in order to obtain prescriptions for them. The FDA and DEA have repeatedly passed information back and forth about hydrocodone, without making any final decisions about the drug.

The DEA classifies drugs on a five-stage scale, which takes into account the potential for addiction. Currently, hydrocodone is considered by the DEA to be a Schedule II controlled substance, the second-highest level. Hydrocodone combinations, such as Vicodin, are Schedule III, and therefore have fewer restrictions on sales.

Schedule II drugs must be locked up at pharmacies. Physicians can only prescribe one bottle at a time and patients must have an original prescription in order to obtain the medication. Schedule III drugs can be refilled up to six times without visiting a doctor, who can phone or fax in a prescription to the pharmacy.

5 Responses to this article

  1. sharon / August 22, 2014 at 10:14 am

    I am a 60 year old and I suffer from degenerative ostio arthritis, I have a full time job witch reqiuers a lot of body work, I also have 3 bolging disks, spurs in my feet, corpral tunnel syndrome and tarcel tunnel syndrome. feet and hands. my spine is so full of pain all the time, and the only thing that gives me any kind of relief, is hydrocodone with tylenol. you can’t tke this away from people like me that need it to live with the pain for the rest of my life. when I take a pill i can do my job, and live a some what normal life, without them I would be bed ridden. as long as we have mri’s and dr. reports. you should leave us alone and just take it away from the abusers. ps. I take 4 a day, that is definetely not abusing them after 4 years.

  2. Avatar of jim jeffery
    jim jeffery / October 25, 2013 at 4:29 pm

    This is just plain crap! Let the police do their job and stop forcing seniors with chronic pain to endure such stupid rules! Simply arrest the users and then doctors who over prescribe! Dilaudid is one thing…Vicodin is not the drug-of-choice of any addict! My spouse is taking 4mg Dilaudid daily after several back surgeries and is forced to see her doctor every 30 days in addition to a pain doctor to control the substance abuse. All this does is add to the cost of our medical bills!

  3. P Hall / January 12, 2013 at 1:46 pm

    Just a little late, aren’t we?? Incorrect that Schedule II drugs are locked up in pharmacies. They can be placed on the shelves with all the other drugs. But then what difference when you get robbed is having them in the safe??? Just puts the pharmacist more at risk of getting shot!!

  4. Shattah206 / January 11, 2013 at 3:18 pm

    ’bout time!

  5. Dwayne / January 10, 2013 at 12:14 pm

    Ban them

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