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.

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    September 20, 2015 at 2:54 AM

    Life, Liberty, & the Pursuit of Happiness. I have a right to live a pain free (as much as possible) existence as I am able. If one is in too much pain one becomes bedridden which also can lead to death. I choose living NOW & my home of the free country should allow it. Everyone has different levels of pain they can deal w/. After a botched shoulder surgery, adult w/ Cerebral Palsy, I have a job, & love life. All this except the CP would be gone without medication. Not heavy, but, yes, moderate. By the way, my father almost did from anti-inflamatories, as well as Mom, & me (I had a severe asthmatic allergic reaction & spontaneous colon bleeding). So, which is safer?

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    jo ann quigley

    July 4, 2015 at 5:56 PM

    I had major foot reconstruction. I had to pay a $40 copay every time I had to refill for 10 vicodin. If the doctor gave me all he thought I would need for the expected duration of my post-op pain, I would have only 1 copay instead of 3-4. this is sheer nonsense! now I am about to have some serious bone crunching surgery on my arm from a torn cartilage and I am probably going to face the same nonsense! this is adding to my medical costs in a time when the governments goal is to reduce medical costs. Get government involved always cost the taxpayer more.

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    Greyt Mom

    February 7, 2015 at 5:00 PM

    The new law is absolutely ridiculous. The low dose hydrocodone is the best remedy for many people especially those that cannot process ibu or asprin. Having to drag my elderly mom to the doc every 90 days is absurd and very difficult just to get a script she has been on for years. The pharmacy hassles us even more with needing additional verification from the docs and questioning dosage. Its on a paper scrip which I thought they eliminated due to fraud but now they are back and it has to be a particular type of pad so not all docs have them. Case in point is our vet who needs to prescribe for our dying dog (hospice) and it is taking 2 weeks to get it from the vet supply bc she doesn’t have the particular pad that the local pharmacy will accept. We have meds that can help and we cant access them now meanwhile the gov is playing doctor. This needs to be repealed yesterday and put back into the normal scheduale.

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    December 29, 2014 at 4:38 PM

    I have type 2 diabetes so my feet suffer from neuropathy I mean they feel hot enough that I can’t sleep or walk on them. Hydrocodone relieves the pain so I can live a normal life. I’m a senior citizen and want to know why such restrictions are being imposed on me. I also want to know who is prescribing this medicine to minors which I’ve heard is the reason for the new regs. If you can’t to something right, stay out of it. Thanks

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