FDA orders major changes for narcotic/acetaminophen painkillers

  1. 0
    Today, the FDA ordered manufacturers of combination acetaminophen/narcotic painkillers like Vicodin, Lortab, and Percocet to reformulate the medications or stop producing them altogether within the next three years. The new regulations will mandate a maximum amount of 325 milligrams of acetaminophen per pill. The move is intended to cut down on the incidence of liver problems resulting from people ingesting too much acetaminophen.

    http://www.nytimes.com/2011/01/14/he.../14fda.html?hp

    In 2009, an FDA advisory committee voted to ban such products from the market altogether, but that recommendation was tempered by concerns about the impact on patients in pain.

    The detail I found most interesting in the story above was that the FDA has no firm plans to go after over-the-counter products containing acetaminophen. That will leave over-the-counter products with higher amounts of acetaminophen than prescription medications like Vicodin.

    Any thoughts on this decision?
  2. 18 Comments so far...

  3. 5
    I read about this the other day. I actually think it's a good idea, and hope this change helps make doctors and nurses more aware of how much Acetaminophen we are truly giving our pts. Some of the docs I work with will order Percocet 2tabs Q4hrs PRN along with Tylenol 1g Q4Hrs PRN. My pharmacy never catches or red flags these orders, and if I didn't call the doc on it I feel we would see more pts getting overdosed on Acetaminophen.
    TDCHIM, lindarn, azhiker96, and 2 others like this.
  4. 1
    1/13/2011
    FDA Drug Safety Communication: Prescription Acetaminophen Products to be Limited to 325 mg Per Dosage Unit; Boxed Warning Will Highlight Potential for Severe Liver Failure

    The U.S. Food and Drug Administration (FDA) is asking drug manufacturers to limit the strength of acetaminophen in prescription drug products, which are predominantly combinations of acetaminophen and opioids. This action will limit the amount of acetaminophen in these products to 325 mg per tablet, capsule, or other dosage unit, making these products safer for patients.

    In addition, a Boxed Warning highlighting the potential for severe liver injury and a Warning highlighting the potential for allergic reactions (e.g., swelling of the face, mouth, and throat, difficulty breathing, itching, or rash) are being added to the label of all prescription drug products that contain acetaminophen.

    These actions will help to reduce the risk of severe liver injury and allergic reactions associated with acetaminophen.
    TDCHIM likes this.
  5. 1
    so darvocet is gone, now lortab wil be gone... tylenol will have a limit.... what exactly will ppl take now for pain???
    TDCHIM likes this.
  6. 1
    Quote from sakura_rn
    so darvocet is gone, now lortab wil be gone... tylenol will have a limit.... what exactly will ppl take now for pain???
    lortab will still be on the market, there will just be less tylenol in it. the active narcotic in it will still be the same drug and dose.
    TDCHIM likes this.
  7. 0
    Quote from ChristineN
    Lortab will still be on the market, there will just be less Tylenol in it. The active narcotic in it will still be the same drug and dose.
    Exactly so - at least for now. I do wonder if this is a first step towards eliminating such products from the market, as the advisory board initially recommended. However, when you think about that havoc that would cause I'm not sure the FDA would go through with it, absent far more striking data.

    I can understand cutting down on the amount of acetaminophen in the compound prescription medications. However, the FDA's decision to leave the OTC acetaminophen-containing medications alone and change only the acetaminophen-containing prescription meds seems a little...wimpy, not to mention inconsistent. I mean, if acetaminophen overdose is such a danger to the public (and I'm definitely not saying it isn't), what should the primary target be: the medications John Q. Public can buy and use indiscriminately, or those which he can only purchase via prescription (a process which theoretically includes some usage counseling/instruction)?

    In my opinion, leaving the OTC medications alone when ordering a massive reformulation of dozens of acetaminophen-containing prescription drugs sends a mixed message to the public. It also seems to show that the FDA is cowed by the thought of going after OTC meds and those who make them, which according to the story is a longer and more difficult process. However, that's just my personal opinion - I'm obviously not privy to the FDA's decision-making process!
  8. 2
    Quote from TDCHIM
    In my opinion, leaving the OTC medications alone when ordering a massive reformulation of dozens of acetaminophen-containing prescription drugs sends a mixed message to the public. It also seems to show that the FDA is cowed by the thought of going after OTC meds and those who make them, which according to the story is a longer and more difficult process. However, that's just my personal opinion - I'm obviously not privy to the FDA's decision-making process!
    I agree with you. I don't have the data but would be willing to wager a couple of dollars that most APAP related liver failure is due to OTC medications. The irony is that manufacturers could cut down the dose on OTC meds and most people would NEVER know since they don't read the fine print.
    TDCHIM and canoehead like this.
  9. 4
    I have often thought that the varying acetaminophen doses of Percocet/Lortab/Vicodin were an accident waiting to happen. Making them ALL be 325 is a good thing, IMO.

    Also agree that it's difficult to find regular strength OTC Tylenol - everything is extra strength. Someone who isn't careful can OD at home and never figure out why. Personally, I shy away from Tylenol. The only reason I take it right now is that I'm pregnant and NSAIDs are a bit out of the question.

    At my workplace (and I'm guessing at a lot of others) we have to verify that we've calculated how much APAP a pt is getting, and that it's a safe dose, before we can pull regular Tylenol, or any combo drug out of the Pyxis. Not allowed to go over 4g for healthy patients, 2g for pts with liver disease or current alcohol use.
    sharpeimom, TDCHIM, canoehead, and 1 other like this.
  10. 1
    The advisory board recommendations are now almost two years old, and the Hospitals in my area have long since stopped using combinations with greater than 325mg APAP. OTC medications are also a concern, there has supposedly been a reduction in the number of OTC meds that have APAP in the mixture in favor of straight APAP and the FDA now requires more prominent labeling when OTC's contain APAP. The big problem with mixing APAP into narcotic meds is that they are in a fixed ratio, if a patient develops opiate tolerance and has to increase their opiate dose, Docs will too often just prescribe more of the same concentration, leading to more APAP. When the recommendations first came out, there was talk of getting rid of APAP containing narcotics all together, which was short lived once it was pointed out that it's harder to abuse meds that are mixed with APAP (they aren't as fun to snort).
    TDCHIM likes this.
  11. 5
    Acetaminophen is the most abused drug on the market currently.

    I don't think people realize how dangerous it can be.
    meteorite36, sharpeimom, ChristineN, and 2 others like this.


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