May 28, 2009 -- The FDA is considering ways to cut the risk of liver injury from acetaminophen in over-the-counter and prescription products.
According to the FDA, U.S. consumers bought more than 28 billion doses of acetaminophen in 2005, including nearly 10 billion doses of over-the-counter products, making it one of the most commonly used drugs in the U.S.
Products containing acetaminophen already carry warnings about the risk of liver injury. And the FDA notes that it considers acetaminophen "safe when used according to the directions on its OTC and [prescription] labeling."
The FDA is concerned about people taking too much acetaminophen -- even a little bit too much -- without realizing it.
"Taking more than the recommended dose of 4 grams per day can cause liver damage, ranging from abnormalities in blood tests used to assess liver function to acute liver failure, and even death," states background material on the FDA's web site.
Three FDA advisory committees will hold a joint meeting in late June to discuss options for reducing liver risk from acetaminophen use.
Meanwhile, the FDA wants consumers to keep three things in mind when using acetaminophen:
- Take no more than the recommended dose of acetaminophen.
- Do not mix acetaminophen-containing products.
- Talk to your doctor about acetaminophen if you drink alcohol or have liver disease.
FDA Weighing Options
The FDA has taken a series of steps since the late 1990s to limit liver injury from acetaminophen. But those steps haven't eliminated the problem.
On its web site, the FDA cites research showing that acetaminophen was the leading cause of acute liver failure in the U.S. from 1998 to 2003, and that there were an estimated 56,000 emergency room visits, 26,000 hospitalizations, and 458 deaths related to acetaminophen-associated overdoses per year from 1990 to 1998.
Three FDA advisory committees will hold a joint meeting on June 29 and 30 to discuss six options to further reduce the risk of liver injury from acetaminophen. Those options are:
- Option 1: Reduce current doses or restrict the current maximum adult daily dose, single adult dose, and tablet strength to prescription only.
- Option 2: Establish package-size limits for OTC acetaminophen products.
- Option 3: Require unit-of-use packaging for prescription acetaminophen products. That means that the products will come to the pharmacy packaged ready for sale, with standardized labeling, instead of in bulk containers.
- Option 4: Expand the product warning information on prescription acetaminophen products. For instance, the FDA might require "acetaminophen" to be on the ingredient list, instead of being listed as "APAP," so that consumers can identify that the drug contains acetaminophen.
- Option 5: Eliminate combination OTC and/or prescription products that contain acetaminophen as well as other active ingredients, because consumers may not realize that those products contain acetaminophen.
- Option 6: Limit dosing formulations for OTC liquid acetaminophen products and require a dosing device (a standardized spoon or container) to be included in the packaging.
Drug Industry Responds
The Consumer Healthcare Products Association (CHPA), a trade group for the over-the-counter drug industry, posted a statement on its web site responding to the options the FDA is considering for acetaminophen.
CHPA President Linda Suydam, DPA, states that CHPA and its members "support efforts to help consumers more safely use this important and trusted ingredient."
Suydam echoes the FDA's statements about acetaminophen's safety when used as labeled, and she notes that the CHPA is assessing the FDA's recommendations and will take part in the FDA's June meeting.
McNeil Consumer Healthcare is the maker of Tylenol. In a statement emailed to WebMD, McNeil Consumer Healthcare states that it is "pleased that the FDA recognizes the important role acetaminophen plays as a safe and effective pain relief options for millions of Americans."
"While we share the FDA's mutual goal of preventing and decreasing the misuse and overdose of acetaminophen, we have concerns that some of the FDA recommendations could discourage appropriate use and are not necessary to addressing the root causes of acetaminophen overdose," McNeil states.
McNeil says that it's working with "regulators, industry, and the health care community to seek new ways to help ensure consumer safety, particularly with regard to the potential for taking too much acetaminophen."