NEWSBRIEF: The U.S. FDA says it's asking the makers of combination painkillers to limit the amount of acetaminophen the drugs contain and to start including warning labels about the dangers of liver damage. Acetaminophen is the drug in Tylenol.
This will effect several of the drugs that are commonly used to treat fibromyalgia pain, including Vicodin (hydrocodone/acetaminophen), Percocet (oxycodone/acetaminophen), and Tylenol with codeine. The level of acetaminophen in these drugs will drop to a maximum of 325 mg.
The FDA says the dosage change will be phased in over three years, which should help avoid any shortages of medication.
The issue behind the change is the high rate of liver toxicity acetaminophen overdose can cause. Often, people taking a combination drug don't realize they've even taken it, or that they've taken the maximum dosage, and they take Tylenol on top of it. Also, because many people build up a tolerance to narcotics over time, they can wind up taking unsafe doses of acetaminophen (and the narcotic as well.) It's also common for people to regard acetaminophen as safe and simply ignore dosage instructions.
If you take a combination painkiller, this change will probably effect your medication. I currently have a prescription for a low dose of Vicodin, which contains 5 mg of hydrocodone and 500 mg of acetaminiphen, so eventually I'll be getting a lower dosage.
The FDA says it believes these medications will be safer and will still be effective for pain. My concern is that if they're less effective, people may take additional Tylenol and wind up getting more than what used to be in their meds; I really hope I'm wrong and that this will help people understand that too much acetaminophen is extremely dangerous.
The FDA had considered banning combination products completely, so this with this it's taking a middle-ground approach. Do you think it was the right way to go? Should they have banned combination drugs? Are you upset that your medication will be changing? How important do you think the acetaminophen is to these drugs' effectiveness? Leave your comments below!
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I, for one, am glad. When all this started, I was concerned I might not be able to get my Vicodin anymore. That doctors wouldn’t prescribe it without the Tylenol in it. So that eases my fears. Also, I get way too much Tylenol now. It’s in my Vicodin, my migraine meds, and my sinus meds. And it only barely works for my sinus headache.
I think it’s what they must do. No other choice really. I don’t know what I would do without percocet. I try not to take it everyday, but, I take it often enough that I would be struggling to do some activities without it.
Since my son has his doctorate of pharmacy, he suggested to my doctor that Norco with 325 mg of acetaminephan be prescribed to me instead of Lortab which had 500 mg of acetaminephan in it, so I changed long ago. Obviously, it doesn’t end my pain because we build a tolerance to the meds over time, but it helps, and I was given a percocet to take if I just have to. However, those can be extremely addictive so a 90 day supply of those usually lasts me 2 years.
I have long believed that the most dangerous component in many painkillers is the acetaminophin and not the narcotic itself. If you study up on this, it is the ingredient that is going to harm your kidneys & liver. That’s why I requested on my own to take 10 mgs. of NORCO which is hydrocodone with only 325 mgs. of acetaminophin. I make sure my dr. does bloodwork every three months to check my kidney & liver function. I have never understood why the government would speak out against the narcotics while never hinting that the other ingredient could be equally or more dangerous. Most people are told it’s the one given in hospitals and they trust it implicitly. I am glad the government has decided to control the amount, and here’s a secret: It doesn’t work anyway!!
I think it is a stupid and unfair decision.
People who doesn’t read the instructions and take overdoses – I mean, it’s sad, but it’s their fault. But people who takes, let’s say vicodin, for years, and therefore doesn’t read now the label on it, might very well not be aware that they would get 175 mg less of Paracetamol in each pill they take. That is not fair.
Anway, I think that’s stupid. People should check what the drugs that they are taking contains, when they first take it. On the other hand, it’s not unreasonable not to check it after you’ve taken it for years, and not to notice that you are now getting less Paracetamol. It’s possible that some of those people would start feeling more achy, and they won’t know why. Actuall, as you stated, the result might be taking more pills. Anyway, at least in my country (Israel), Paracetamol pills comes in 500 mg tablets. So let’s say that I take a Vicodine pill and want to take another 175 mg of Paracetamol, to reach the amount of Paracetamol that I’m taking currently (actually, I’m not taking it currently, but some people are). How would I do that? If I cut the pill in 2, I’d be taking 575 mg of paracetamol each time. If I cut it to three I’d probably not get equal amounts in each fragement, and even if I do I would just get 166.667 mg in each fragement (doesn’t seem significant. But anyway, I won’t get equal amounts because I won’t know where to cut it!).
To me it seems like an idiotic decision, and I really resent the idea of making one person suffer more, because of another person’s mistakes.
And yes, people might be taking a pill which contains more Paracetamol (Acetaminophen) than they need, but the solution should be to write them a prescription for the narcotic drug without the Paracetamol, and to let them add the Paracetamol themeselves. That way they would know that their Paracetamol dosage had been changed, because they would be given another drug and their doctor would probably tell them that it doesn’t contain Paracetamol.
I agree with Omer – prescribe them separately so that the patient is conscious of how much medication they’re taking. One thing that I have also started doing is checking everything, including my supplements, on Drugs.com before I start taking anything. It lets you know what is in a medication & if there are any potential interactions. It’s not completely fool-proof, but it’s better than leaving my safety in the hands of my doctor or pharmacist… no one cares more about my health than me, so I check & double-check!
I’ve been waiting for the FDA to make this decision for a long time, and frankly, I’m so grateful they’ve done so at last. Acetaminephin is very toxic to the liver and not good for the kidneys either. I have fibromyalgia, and have taken the combination painkillers while at the same time worrying about what was happening to my liver. To control the pain I was having to take way too much acetaminephin for my liver to handle. I currently take a single-component painkiller that contains no acetaminephine, and feel much more secure now.
I find it interesting that the FDA is going to limit the amount of acetemeniphen in RX meds, but not OTC meds, from what I’ve read so far. (Someone please correct me if I’m wrong here.) So, you’ll still be able to purchase “extra strength,” aka 500 mg acetemeniphen over the counter, but can’t get that in prescription meds, which is odd, since OTC meds are obviously so much more widely used than RX meds.
As for liver damage, I take milk thistle daily to help combat liver damage from all the meds I take for my fibro and myofascial pain syndrome, which both my primary and pain management docs say can’t hurt, although there’s no proven benefit. They both encourage me to take ibuprofen as an additional OTC pain med with my prescription pain med (Norco 10/325) rather than add on more acetemenipen to help protect my liver, since ibuprofen is apparently processed by the kidneys rather than the liver.
Still, I’m annoyed overall that the FDA again chooses to target prescription pain meds that, if taken responsibly, are a life-saver for those of us who live in constant pain and rely on them to give us the ability to function in some semblance of normalcy and productivity (as with Darvocet). Why the FDA can’t focus more on approving meds that are beneficial to folks like us and less on nitpicking is beyond me. I understand they want to protect the public at large, but still — people need to be responsible for themselves and the government needs to stop being a “nanny state” because some individuals are too stupid to realize they shouldn’t mix certain meds with others.
The more the FDA starts messing around with limiting what amounts of this and that can be in pain medications, the worse it’s going to get for those of us who require them to manage our conditions.
The FDA recently pulled Darvocet from the market. It has been around since the down of time. The reason given was that it cause heart problems in some people…they think. Most docs won’t prescribe a narcotic at all because the fed breathe down their throats.
I am glad they are decreasing the acetamenophen but why not just pull it out altogether?
I personally think that our FDA which relies on the drug industry to regulate itself or lets them actually write the regulations and is only abetting the drug companies. This will all eventually result in us having to pay more for drugs that are still in patent.
We are at the mercy of big Pharma.
Thank you for this information. I was not aware of that the FDA was looking into this drug combo.
I don’t know if it’s a good or bad thing, but people with low blood pressure need to be very, very careful taking hyrocodone. I was prescribed this (5mg with the Tylenol) without taking more than the prescribed dose or with any other pain killers, and I fainted twice, once causing a 911 call and going to the hospital.
Years ago I had surgery and the anesthesiologist told me afterward my blood pressure had a tendency to drop dangerously low, and I should let the doctors know if I have any future surgeries. After that surgery they did not give me the ‘pain pump’ which is used for after surgery pain and uses narcotics. I was only given Tylenol.
I did let my PC doc know this. A couple of years ago I was given generic Vicodin for the fibro pain and noticed I’d often feel a bit woozy. I only took the stuff when I absolutely had to – not the maximum dosage.
About three months ago I took one 5/500 generic Vicodin and felt especially dizzy. It was close to bedtime so I went to brush my teeth. The next thing I know my fiance was standing over me trying to wake me up and taking to 911 on the phone. I was at the hospital for several hours with a cracked tailbone and a badly wrenched neck.
After talking with the doctor there we came to the conclusion that the pain killer had suddenly dropped my blood pressure causing me to faint. My bp is never over 117/75 but is frequently in the 85/55ish area. This is frustrating to me because when I get my bp taken the nurse or doctor almost always says, Wow, that’s great.” I have read low bp can cause some serious illnesses and I have even asked how low does it have to go before red flags start popping up. After all if your bp gets too low you end up dead.
That’s my story with Vicodin although it really didn’t answer your question directly.
That is why my Rheumatologist does blood work! I think the government is making it more difficult for chronic pain sufferers to get some pain relief-pain relief that is only temporary. I still subscribe to the theory that only a person who has Fibromyalgia should treat others with Fibromyalgia!!! Thanks for the information.
I take Norco. It is 10 mg of hydrocodone and 325 mg of acetaminophene.