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Acetaminophen – New FDA limits underscore inadvertent overdose dangers

  [ 18 votes ]   [ Discuss This Article ] • January 13, 2011

A component of hundreds of combo Rx & OTC products, acetaminophen is a serious drug and more is not better, new FDA limits confirm.

On Jan 13 the FDA announced it was taking more steps to reduce consumer risks of acetaminophen (Tylenol, paracetamol, etc.) overdose – though perhaps more steps are needed.

Specifically, the FDA announced new limits (no more than 325 mg per tablet/capsule for products made for adults) on the amount of acetaminophen allowed in the many prescription drugs that combine this pain & fever reducing drug with other ingredients. Usually these other ingredients include opioids such as codeine (Tylenol with Codeine), oxycodone (Percocet), and hydrocodone (Vicodin). See the full FDA Rx product listing, affected products in italics.

In line with this, Rx manufacturers will be required to change the labels on these products so as to highlight the serious consequences of exceeding recommended doses – often liver damage or failure resulting in death or a liver transplant. According to the FDA, “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.” Many cases have involved consumers unwittingly taking multiple products containing acetaminophen.

Over-the-Counter Drugs Not Included
The combination Rx drugs “account for nearly half of all cases of acetaminophen-related liver failure in the United States” the FDA states – the other half being liver failure owing to excessive doses of the many over-the-counter drug products containing acetaminophen that are not included in the FDA dose limits. These make up about 80% of all acetaminophen-containing products.

For a list of more than 200 acetaminophen-containing over-the-counter product brand names, click here.

Three Year Phase-In
The new regulations regarding prescription acetaminophen combo drugs and their labels will be phased in over three years (though health care professionals are being advised of them now), and so “should not create a shortage of pain medication.” Consumers are advised to check with their physicians on the maximum allowable amount of acetaminophen per 24-hour period.


Source: FDA announcements, website, press releases, Jan 13, 2011

Note: For other recent news, see “Acetaminophen even once a month linked to doubled risk of asthma in adolescents, worldwide study finds.”

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