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