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  #1  
Old 18-12-2013, 22:54
been_there been_there is offline
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U.S. FDA - Products to be Limited to 325 mg Per Dosage Unit

http://anonym.to/?http://www.fda.gov.../ucm239821.htm

Say goodbye to the X/500mg hydro-oxy/APAP combos.. 1/1/2014

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

[1-13-2011] 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.

Acetaminophen is widely and effectively used in both prescription and over-the-counter (OTC) products to reduce pain and fever. It is one of the most commonly-used drugs in the United States. Examples of prescription products that contain acetaminophen include hydrocodone with acetaminophen (Vicodin, Lortab), and oxycodone with acetaminophen (Tylox, Percocet).

OTC products containing acetaminophen (e.g., Tylenol) are not affected by this action. Information about the potential for liver injury is already required on the label for OTC products containing acetaminophen. FDA is continuing to evaluate ways to reduce the risk of acetaminophen related liver injury from OTC products. Additional safety measures relating to OTC acetaminophen products will be taken through separate action, such as a rulemaking as part of the ongoing OTC monograph proceeding for internal analgesic drug products.

Last edited by Phenoxide; 22-12-2013 at 20:26. Reason: link anonymization, formatting fix
  #2  
Old 20-12-2013, 14:07
kickstart kickstart is offline
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Re: US FDA - Products to be Limited to 325 mg Per Dosage Unit

I wonder how this will affect users getting prescriptions. Will people with 5/500 be switched to a different strength? It seems like 5/500 is so common. I guess it'll have to be 5/325 now.
  #3  
Old 20-12-2013, 16:33
baZING baZING is offline
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Re: US FDA - Products to be Limited to 325 mg Per Dosage Unit

I heard about this a while back.

But you will notice it is dated January 2011, almost three years ago.

As far as I know, this has not come into play yet, and being how old the suggestion was I'm not sure if it has fizzled and died. Products containing 500mg, or even 6-750mg of APAP per unit are still widely available.

However, these things frequently take a while to kick in but I wonder why there is no mention in this release about the time-frame expected, if it is in fact a mandate rather than a suggestion. It would be most excellent if you could do some more digging, been_there, since you started this thread.

Also kickstart, IME 5/325 tablets are just as common (if not moreso) than 5/500, especially in oxy/APAP rather than hydrocodone/APAP.
  #4  
Old 20-12-2013, 18:37
been_there been_there is offline
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Re: US FDA - Products to be Limited to 325 mg Per Dosage Unit

Quote:
Originally Posted by baZING View Post
But you will notice it is dated January 2011, almost three years ago.
The US FDA gave a 3 years notice.

I did my homework before posting. Hope this helps!

FDA-2011-N-0021-0001 The orginal source of this came from my pharmacist.

http://www.drugs-forum.com/forum/att...1&d=1387743492

SUMMARY:

The Food and Drug Administration (FDA) is taking steps to reduce the maximum dosage unit strength of acetaminophen in prescription drug products. This change will provide an increased margin of safety to help prevent liver damage due to acetaminophen overdosing, a serious public health problem. This notice explains the reasons for the reduction in dosage unit strength and describes how FDA is implementing it for approved prescription drug products that exceed the new maximum tablet or capsule strength. FDA is also requiring safety labeling changes, including a new boxed warning, for acetaminophen-containing prescription drug products to address new safety information about the risk of liver damage.

DATES:

Sponsors of approved prescription drug products containing more than 325 milligrams (mg) of acetaminophen have until January 14, 2014 to request that FDA withdraw approval of the product’s application, after which they may be subject to action by FDA.

FOR FURTHER INFORMATION CONTACT:

Faith Dugan, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6182, Silver Spring, MD 20993–0002, 301–796–3446.

been_there added 15 Minutes and 45 Seconds later...

More from drugs.com:

The FDA has asked manufacturers to limit the maximum amount of acetaminophen in prescription products to 325 mg per dosage unit. There are no data that indicate that taking more than 325 mg of acetaminophen per dosage unit provides more pain relief. The goal of the FDA is to reduce the risk of severe liver injury from acetaminophen overdose, which can lead to liver failure, liver transplant, and even death. The total number of units that may be prescribed and the time intervals for dosing will not change. Drug companies will have until January 14, 2014 to comply with FDA requirements.

Usual acetaminophen maximum dosage is 4 g per day.

Post Quality Evaluations:
Fantastic research and timely posting of pertinent news.
Attached Files
File Type: pdf 2011-709.pdf (183.1 KB, 1 views)

Last edited by Phenoxide; 22-12-2013 at 20:21. Reason: document uploaded, formatting fixed
  #5  
Old 20-12-2013, 20:41
baZING baZING is offline
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Re: US FDA - Products to be Limited to 325 mg Per Dosage Unit

Excellent! That's exactly what I was hoping you would have found, so thank you for posting that.

For what it's worth, as far as I know the length of time that the FDA allows between making a decision and the expected implementation of said decision can vary greatly. It is somewhat confusing even from a common sense level that they gave so much time; I realize that things take time and it's not so simple to enact but three years seems like a long time to willingly allow this to continue. I'm not questioning that it's true... I just don't like it.

It should be noted the FDA advisory panel recently lowered the recommended dosage of APAP to 3g per day, not four... but it was 4g in the past. IIRC the reasoning behind this was that so many products contain acetaminophen (like cough syrup, for example) that people might not be aware about, so if the recommended dose was 3g per day this allowed some "wiggle room" if people were accidentally taking other APAP-containing products. I wonder if that recommendation had something to do with the changes being made to combination opioid products, as well.

So, to the best of your knowledge and the information you can find, is this only applicable to prescription products? That does seem to be the case, but Extra Strength Tylenol is very common and those are 500mg of APAP. There is less impetus to abuse these because they don't contain narcotics, of course, but an unknowing person in a lot of pain could easily take 3-4 thinking it would help. 2000mg of APAP at one time is unlikely to cause acute liver failure immediately, but certainly is not a good plan over time.

I'm not blind; the above clearly states that it is prescription drugs being targeted... that just seems like a big oversight since there are other (OTC) products that contain more than 325mg of APAP per unit and don't need to contain opioids to be accidentally abused. I also wonder if there are any other prescription drugs that routinely contain more than 325mg of APAP per unit that will be effected, or if this is a decision driven chiefly by narcotics. Certainly I think combination opioids are the most common prescriptions that contain larger amounts of acetaminophen.

Please note that it is requested you don't link directly to .gov sites. You can still provide it, but insert spaces or something to break the actual hyperlink. Even better would be to upload the file itself; which can be done pretty easily through the Advanced post editor. Not a huge deal... now you know for next time.

Last edited by baZING; 20-12-2013 at 20:49.
  #6  
Old 20-12-2013, 20:56
been_there been_there is offline
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Re: US FDA - Products to be Limited to 325 mg Per Dosage Unit

Quote:
Originally Posted by baZING View Post
So, to the best of your knowledge and the information you can find, is this only applicable to prescription products?
I read in there somewhere that OTC products would not be affected. The point is merely people upping their lortab/vicodin intake for pain or recreation and adversely consuming too much APAP.

As far as you 3G/Day APA limit. I have read that in plenty of places but I think that the number is still officially 4G.

http://www.tylenol.com/safety-dosing/faq

Tylenol's US website still reads 4,000mg/day

Good work keeping this thread going! we'll get to the bottom of this!
  #7  
Old 20-12-2013, 21:40
baZING baZING is offline
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Re: US FDA - Products to be Limited to 325 mg Per Dosage Unit

Actually, the Tylenol website has multiple guidelines that stay closer to the 3000mg mark. If you look at the adult dosing guidelines, it recommends no more than ten regular strength tabs (3250mg), six extra strength (3000mg) or 6 650mg extra strength extended release (3900mg). The latter is the only one that comes closer to the 4000mg mark, and other areas on the website seem to confirm the 3000mg recommendation. Regardless, you'll see below that it may not have actually been that the FDA recommended 3000mg but rather just recommended the max daily dose be changed to lower than 4000mg.

In addition, I'm attaching an announcement by the Nevada Medicaid Service that confirms both the FDA's decision to restrict 500mg and 6/750mg-strength combination products containing APAP, as well as their recommendation to lower the maximum recommended daily dose.

Lastly, here's a quote from the US News Health Section, from a while back:

Quote:
The FDA advisory panel voted 21-16 Tuesday to lower the maximum daily dose of nonprescription acetaminophen, which is currently 4 grams - equal to eight pills of a drug such as Extra Strength Tylenol. The panel was not asked to recommend another maximum daily dose.

The panel also voted 24-13 to limit the maximum single dose of acetaminophen to 650 milligrams. The current single dose of Extra Strength Tylenol, for instance, is 1,000 milligrams.
The panel also voted 26-11 to make the 1,000-milligram dose of acetaminophen available only by prescription.
So while the panel was not asked to come up with a lower dose than 4000mg per day, McNeil (Tylenol's parent company) were the ones who voluntarily decided upon the 3000mg figure... or so it seems. I could have sworn I've read elsewhere that (at least eventually) it was indeed the FDA who recommended 3000mg. The FDA and the FDA Advisory Board are not the exact same entity, but I would be lying if I said I understand precisely how they differ.

Thanks for bringing this to everyone's attention as the actual date of implementation draws nearer. I have requested it be moved to the main OOO forum as it effects both hydrocodone/APAP as well as oxycodone/APAP products.
Attached Files
File Type: pdf web_announcement_468_20120425.pdf (61.1 KB, 0 views)
  #8  
Old 23-12-2013, 17:01
kickstart kickstart is offline
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Re: U.S. FDA - Products to be Limited to 325 mg Per Dosage Unit

It is also interesting because there is also the FDA trying to get hydrocodone as a Schedule II substance as well, which I am pretty sure there is a thread about on this site, but think it has a lot to do with this one as well:
Quote:
According to a statement from Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research, the FDA's decision would recommend reclassification of hydrocodone combination products as Schedule II rather than a Schedule III medication under the Controlled Substances Act. The change would also require the medications to be available only with a written prescription except under certain emergencies and would not allow refills.
It seems like hydrocodone is becoming more and more like oxycodone. I also wonder that now that all of these restrictions are coming out for opiates, what will doctors and dentists use for minor surgeries now? Will they still prescribe hydrocodone, or now because it is Schedule II (Well could be) that they would prescribe something like T-3 or Tramadol.

It will gradually become harder and harder to legally obtain opiates, even for people who need them. But then there's also the talk about Zohydro, a pure extended release Hydrocodone similar to OxyContin that can be crushed. This would be huge for abusers, as each pill is like 10 times stronger than a Vicodin.
  #9  
Old 02-01-2014, 15:37
Pagoda Pagoda is offline
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Re: U.S. FDA - Products to be Limited to 325 mg Per Dosage Unit

Why dont they just take out the apap all together. I mean here they are admitting it themselves how dangerous it is showing that even a low amount like 6 in a day is pushing it. They should know by now that people are gonna abuse it to get high no matter what. Take out the apap and save lives. I'm no expert on the subject but I highly doubt the apap really makes that much of a difference anyway. Having just the opiate in it is still gonna help with pain but without the risk of liver damage. I believe they know that the apap barely does jackshit but they have it as an abuse deterrent. They succeeded. For a lot of people it does deter them. Deters them right into the direction of heroin.
  #10  
Old 06-01-2014, 03:50
OceanDreamer OceanDreamer is offline
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Re: U.S. FDA - Products to be Limited to 325 mg Per Dosage Unit

I have heard from 2 pharmacists (who are friends and fellow "partakers"), that they are trying to totally eliminate the 5/500 (hydro & oxy). From what they have been told, the "normal" vicodan (5/500, the type you are more likely to get from an ER) will be replaced by 5mg "norco" (5/325). Norco/lortab/whatever they call it where you are, will go to 5/200. They are also trying to make ANY hydro script above 10mg per pill a C2 (triplicate), so no more refills or call ins. You will have to see the doc each month to get a new written script the same as Oxy, Methadone, Morph, etc.

They did say this has been talked about for a long time and as of now, it is all rumor, but if it goes the way that Soma did (went from being a non-controlled drug that you could legally buy online to a C4 a couple years ago), it will probably happen..........
  #11  
Old 18-01-2014, 04:43
DiabolicScheme DiabolicScheme is offline
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Re: U.S. FDA - Products to be Limited to 325 mg Per Dosage Unit

Recent (last month) prescription of hydrocodone was at 325mg per tablet; I think they were phasing it out late last year.

Still just goes to show you how little people know about what they take into their bodies, it's sad that once again the government has to be the babysitter. Who wants to bet that this doesn't reduce the liver failure rates from overdosing on acetaminophen?

If the government really cared about this they'd remove the ingredient completely and have Tylenol as secondary but hey I guess killing people to prevent drug abuse is more important.
  #12  
Old 30-01-2014, 21:40
been_there been_there is offline
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Re: U.S. FDA - Products to be Limited to 325 mg Per Dosage Unit

Quote:
Originally Posted by OceanDreamer View Post
From what they have been told, the "normal" vicodan (5/500, the type you are more likely to get from an ER) will be replaced by 5mg "norco" (5/325).
This is the topic of this thread although I'm not sure that the 325 to 200 drop is documented anywhere in the FDA paperwork.. I have to review that.. I have spoke to a pharmacist about why my doctor continues to write scripts for Lortab even though the new rule went into effect a couple of weeks ago.. His response was that they will continue to supply them until inventory runs out (US Retailer "Target" in this case) and that they have the authority to change a script without Dr. permission (Lortab to Norco). The doctor would be told in hindsight.

I'm anxious.. Not to abuse more, just to lower the load on my liver.. Scary to think about years of pain meds and what the fallout will be..

been_there added 12 Minutes and 26 Seconds later...

Quote:
Originally Posted by DiabolicScheme View Post
Who wants to bet that this doesn't reduce the liver failure rates from overdosing on acetaminophen?
You will now be able to increase your HYDRO intake by 35% by comparison to equal Lortab/Norco meds with the same APAP intake.

Sounds like more Hydrocodone addicts to me.

"less abusable" lol.. More Pills, More Demand, More Money..

Last edited by been_there; 30-01-2014 at 21:40. Reason: Automerged Doublepost

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