FDA limits acetaminophen in prescription combination products

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.

This is a great way to improve patient safety, but what about over-the-counter medications? So many patients do not realize that a number of over-the-counter cold medicines contain a large amount of acetaminophen. I think these products should have stronger warnings so that patients are not taking double or triple doses of acetaminophen. Some patients are taking a combo cold medicine for their "cold" symptoms, then they'll take a few Tylenol pills for their "headache," and before you know it, they've consumed a large volume of acetaminophen.

Then again, you can't have a Black Box warning on an over-the-counter medication.

You can read the FDA press release here.

Children's Tylenol, Motrin, Benadryl, and other medicines recalled

Working in consultation with the United States Food and Drug Administration (FDA), McNeil Consumer Healthcare is implementing a voluntary recall of infant and children’s liquid products due to manufacturing deficiencies which may affect quality, purity or potency. Following McNeil’s recall announcement on Friday evening, the FDA is providing additional advice to consumers.
 
What products are affected by this recall?
The products include certain liquid infant’s and children’s Tylenol®, Motrin®, Zyrtec®, and Benadryl® products. For a complete list of recalled products, please see the recall notice

To learn more, visit the FDA website here.

J&J recalling some Children's and Infant's liquid Tylenol

Johnson and Johnson is recalling some children's and infant's Tylenol liquid products manufactured between April 2008 and June 2008 as a safeguard against potential bacterial contamination.

I'm surprised that the FDA hasn't announced anything. I also don't see anything on the corporate Johnson and Johnson site. So, to read the story on CNNMoney.com, click here.

Should we eliminate combination products that contain acetaminophen?

So many combination products contain acetaminophen. You'll find them in prescription drugs (like Vicodin and Percocet) as well as in many over-the-counter (OTC) cough/cold medicines. For instance, Nyquil has an equivalent dose of 1000 mg of Tylenol (acetaminophen). If someone took Nyquil for a cold and then took some additional Tylenol for a headache, he could have a serious liver problem in a few days from a Tylenol overdose. Many people don't look at the ingredients of cold/cough medicines and they also don't realize that acetaminophen = Tylenol (just a different name).

Now, the FDA panel focused on prescription combination products that contain acetaminophen. Why? Because the data shows that acetaminophen-related overdoses occur mainly with prescription drugs. Maybe that's because some people are taking Vicodin and Percocet for drug-abuse problems and they're more prone to suicidal tendencies. Perhaps some people are "popping pain pills" to relieve intractable pain.

Regardless, I think that if we're going to change combination prescription drugs, then we should also re-evaluate combination OTC products that contain acetaminophen. Otherwise, consumers may get the wrong message. My hope is that we simply improve labeling and public health awareness but that all the products still remain available.

Government panel may pull drugs containing acetaminophen

A government panel assembled by the FDA may make some recommendations to pull some very common medications off the shelf. Acetaminophen (common brand name Tylenol) is a very safe drug that is mainly used to treat pain and fevers. However, an overdose of Tylenol can also be lethal because it can destroy the liver. We can live without our spleen, but we can't live without our liver, so that's why a Tylenol overdose can be fatal. Some people die as they wait for a liver transplant.

According to CNN (quoting the FDA), "overdoses of acetaminophen have been linked to 56,000 emergency room visits, 26,000 hospitalizations and 458 deaths during the 1990s." Of course, we also know that millions of people safely use Tylenol without any problems. The advisory panel could vote to pull over-the-counter drugs that use acetaminophen in combination with other ingredients that treat flu and cold symptoms, allergies or sleeplessness. This includes common drugs like: NyQuil, Pamprin and Allerest. Does this just mean that consumers will learn how to use over-the-counter drugs for off-label purposes? The FDA doesn't have to follow the advisory panel recommendation, so when this is all over, it may all be meaningless.

CNN also reports that the Consumer Healthcare Products Association (CHPA) strongly opposes the elimination of OTC (over-the-counter) acetaminophen containing combination products. Interesting? Click here to read the CNN story.