FDA weighs tougher warnings for acetaminophen

When it comes to acute liver damage, acetaminophen, the painkilling ingredient in Tylenol, is a bigger hazard than alcohol.


Photo by sun dazed via Flickr

Some 56,000 Americans end up in the ER each year as a result of the drug, a ubiquitous ingredient in over-the-counter cough and cold remedies and also one half of the most prescribed medicine in the United Stateshydrocodone-APAP.

So the Food and Drug Administration, which has ratcheted up warnings about acetaminophen’s risk in recent years, is holding a two-day meeting seeking advice on what to do next.

For consumers, a big part of the problem is that taking even a little more than the highest recommended daily dose (4 grams for adults) can lead to serious liver damage.

About half the nearly 500 annual cases of liver failure linked to acetaminophen are accidental. It’s easy to overlook the total dose of acetaminophen when taking a pain pill and a combination medicine, for instance.

One option would be a ban on combination drugs, like Theraflu and NyQuil. Makers of over-the-counter drugs say prescription-strength medicines containing acetaminophen account for most of the problems.

The outcome of the meeting will be “an important first test of the FDA’s new power to impose risk evaluation and mitigation strategies on manufacturers of widely used drugs that pose a small but distinct public health threat when misused or abused,” writes FDA-watcher Merrill Goozner on the blog GoozNews.

1 thought on “FDA weighs tougher warnings for acetaminophen

  1. Avatar photocharlene

    What are we to do. i am always in pain due to my r/a. My daughter wants me to go the holistic way, which i find time consuming and costly. the medicines i do take help and now i hear about liver damage. Dosen’t all medications have there pros and cons. to stay bed ridden is worse than moaning and groaning which i rather do when i move around and then take my meds at bedtime. a good night sleep is all i want becauseit’s the only time i feel no pain.


Leave a Reply