Reducing acetaminophen’s dangers

Thursday, January 13, 2011

The Food and Drug Administration (FDA) has taken new steps to reduce the risk of severe liver injury associated with acetaminophen, a widely used pain- and fever-reducing drug that is the active ingredient in over-the-counter Tylenol and other pain killers, including some prescription drugs such as such as codeine (Tylenol with Codeine), oxycodone (Percocet) and hydrocodone (Vicodin).

Acetaminophen is generally believed to be safe for healthy people if recommended dosages are not exceeded. (People with liver disease should ask their doctors before taking acetaminophen.)

The FDA announced that it is:

• asking all makers of prescription products that contain acetaminophen to limit the amount of the drug to 325 milligrams per tablet or capsule
• requiring a Boxed Warning on all prescription acetaminophen products that highlights the potential risk for severe liver injury. Boxed Warnings are FDA's strongest warnings for prescription drug products, used for calling attention to serious or life-threatening risks

In addition, the FDA is requiring a warning on labels of all prescription products that contain acetaminophen that highlights the potential for allergic reactions. These allergic reactions include swelling of the face, mouth, and throat; difficulty breathing; itching; and rash.

Examples of other prescription acetaminophen combination products may be found here.

Click here for the FDA alert on this topic.