FDA LIMITS ACETAMINOPHEN TO 325 MG FOR COMBO MEDICATIONS

FDA limits acetaminophen in prescription combination products; requires liver toxicity warnings

Agency strategy caps maximum at 325 milligrams to reduce risk of liver toxicity

The U.S. Food and Drug Administration is asking manufacturers of prescription combination products that contain acetaminophen to limit the amount of acetaminophen to no more than 325 milligrams (mg) in each tablet or capsule.

The FDA also is requiring manufacturers to update labels of all prescription combination acetaminophen products to warn of the potential risk for severe liver injury.

Acetaminophen, also called APAP, is a drug that relieves pain and fever and can be found in both prescription and over-the-counter (OTC) products. It is combined in many prescription products with other ingredients, usually opioids such as codeine (Tylenol with Codeine), oxycodone (Percocet), and hydrocodone (Vicodin). OTC acetaminophen products are not affected by today's action.

“FDA is taking this action to make prescription combination pain medications containing acetaminophen safer for patients to use,” said Sandra Kweder, M.D., deputy director of the Office of New Drugs in FDA’s Center for Drug Evaluation and Research (CDER). “Overdose from prescription combination products containing acetaminophen account for nearly half of all cases of acetaminophen-related liver failure in the United States; many of which result in liver transplant or death.”

The elimination of higher-dose prescription combination acetaminophen products will be phased in over three years and should not create a shortage of pain medication. Patients and health care professionals are being notified of the new limitation on acetaminophen content, and of the labeling change, in a drug safety communication issued by CDER. The FDA believes that prescription combination products containing no more than 325 mg of acetaminophen per tablet are effective for treating pain.

“There is no immediate danger to patients who take these combination pain medications and they should continue to take them as directed by their health care provider,” said Kweder. "The risk of liver injury primarily occurs when patients take multiple products containing acetaminophen at one time and exceed the current maximum dose of 4,000 milligrams within a 24-hour period.”

Acetaminophen is also widely used as an over-the-counter pain and fever medication, and is combined with other OTC ingredients, such as cough and cold ingredients. The actions FDA is taking for prescription acetaminophen products do not affect OTC acetaminophen products.

Because of continued reports of liver injury, FDA proposes that boxed warnings, the agency’s strongest warning for prescription drugs, be added to all acetaminophen prescription products. Most of the cases of severe liver injury occurred in patients who took more than the prescribed dose of an acetaminophen-containing product in a 24-hour period, took more than one acetaminophen-containing product at the same time, or drank alcohol while taking acetaminophen products.

An FDA advisory committee discussed the issue at a meeting in June, 2009, and recommended strengthening the warning about severe liver injury on the drug labels of prescription products containing acetaminophen.

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm239894.htm

[trdofbeingtrd]

Wow, I wonder how this is going to affect everything and everyone.

[peekawho]

I think it's about time.   It can be challenging to get enough pain relief when you have to limit your meds b/c of acetaminophen amounts.  
As long as the meds are still available while the switch is taking place.

If I want Tylenol, I would prefer to take it separately.

[Heiferly]

I, for one, am really excited about this. I had an incident in the past where a doctor unknowingly advised me to take large, frequent doses of tylenol to manage a dangerously high fever that turned out to be related to an illness involving my liver in the first place! As you can imagine, the added strain on my liver from all that tylenol wad pretty disastrous, and even after the acute emergency was over, it took a year of Rx treatment to fix the resultant anemia. One of my blood labs related to liver function still is usually slightly out of range even now, about 15 years later.

Even with that history, when I tell some docs that I need a pain med that has little or no tylenol (and explain the above), they often ignore my request and give me vicodin. Presumably, they figure I'm a drug-seeker trying to get oxycodone or stronger that don't contain tylenol? Honestly, if hydrocodone came in a non-combo form I'd be golden.

I am flabbergasted that just this week in the hospital was the first time I was ever given norco. This may sound stupid, but I had never even heard of it! In all my pleas for less tylenol, no doc thought to offer me this? Two of these every 5 or so hours is making my post-surgical pain manageable enough to sneak in some sleep, and I'm not ODing on tylenol in a 24 hour period and over-taxing my liver.

[peekawho]

Norco will become the norm, I hope.  I've been on it for nearly 2 years.  Much, much safer choice.  

I believe it is much more expensive though, for those without a prescription drug plan.  I wonder if it will become even more expensive, with the new recommendations?

[Ashelen]

I take norco too....I'm ecstatic about this law. about time, IMO.