Acetaminophen Safety: FAQ
Questions and Answers About Acetaminophen, Liver Damage Risk, and the FDA
An FDA advisory committee recently recommended that the FDA set certain limits on acetaminophen, a drug that is used in many prescription and nonprescription medicines to relieve pain and reduce fever.
Those limits could include taking off the market some prescription drugs, such as the painkillers Percocet and Vicodin, which combine acetaminophen with other active ingredients.
The reason for the proposed limits is the risk of liver damage from taking too much acetaminophen.
That risk isn't new, and the FDA advisory committees don't set policy -- that's the FDA's job, and the FDA hasn't decided what to do about acetaminophen yet.
But the FDA advisory committee meeting is drawing attention to acetaminophen. Here are questions and answers about the drug, its risks, its safe use, and how the FDA is handling it.
What is acetaminophen?
Acetaminophen is a drug found in many over-the-counter products (which are sold without a prescription) including Tylenol, aspirin-free Anacin, Excedrin, and numerous cold medicines. It's also found in many prescription medicines.
Acetaminophen is used as a pain reliever and fever reducer. It's the only active ingredient in some medicines; other medications combine acetaminophen with other active ingredients.
The FDA's web site notes that medicines containing acetaminophen come in many forms, including drops, syrups, capsules, and pills.
Is acetaminophen safe?
On its web site, the FDA states that "acetaminophen is an important drug, and its effectiveness in relieving pain and fever is widely known. This drug is generally considered safe when used according to the directions on its labeling. But taking more than the recommended amount can cause liver damage, ranging from abnormalities in liver function blood tests, to acute liver, failure, and even death."
Is the liver risk from taking too much acetaminophen something new?
No. It's a known risk that's already noted on drug labels.
What was the FDA advisory committee meeting about?
The FDA has been concerned that despite efforts taken by the FDA and the drug industry over the years, some people still take too much acetaminophen and wind up with liver damage.
On June 29 and 30, three FDA advisory committees held a joint meeting to consider various options to try to reduce liver damage from acetaminophen use in over-the-counter and prescription drugs, including the painkillers Vicodin and Percocet.
Those options that the committees considered are as follows:
- Lower the maximum total daily dose in over-the-counter products.
- Limit the maximum single dose for adults taking over-the-counter products.
- Switch the current maximum dose of acetaminophen to prescription status.
- Limit pack sizes for over-the-counter acetaminophen products.
- Eliminate over-the-counter products that combine acetaminophen with other drugs.
- Make only one concentration of nonprescription liquid acetaminophen available.
- Eliminate prescription drugs that combine acetaminophen with other drugs.
- Require certain packaging changes for prescription drugs that combine acetaminophen with other drugs.
- Require a "black box" warning (the FDA's sternest warning) for prescription medicines that combine acetaminophen with other drugs.