Product Liability

FDA limits acetaminophen levels, adds warning to prescription drugs

The Food and Drug Administration (FDA) is asking the manufacturers of prescription drugs that contain acetaminophen to limit the amount of acetaminophen to no more than 325 milligrams (mg) in each tablet or capsule, and to update their safety labels to include a black box warning for the risk of severe liver injury. Boxed warnings are the FDA’s strongest warning for prescription drugs and include situations where there is a significant risk for serious or even life-threatening reactions.

Acetaminophen is found in both over-the-counter and prescription medicines and is used to relieve pain and fever. Over-the-counter products that contain acetaminophen include Tylenol and Midol and do not exceed the 325-milligram limit per tablet criteria the FDA is imposing. Many prescription drugs that contain acetaminophen in these higher levels are combined with other ingredients, usually opioids such as codeine (Tylenol with Codeine), oxycodone (Percocet), and hydrocodone (Vicodin).

Overdose from prescription combination products containing acetaminophen account for nearly half of all cases of acetaminophen-related liver failure in the United States. This type of liver failure may result in liver transplant or death.

The FDA says it will begin phasing out the higher-dose prescription combination acetaminophen products over the next three years. By doing this, the agency said there should be no shortage of pain medication. Patients and health care professionals are being notified of the new limitations of acetaminophen content and the labeling change.

The agency also says there is no immediate danger to patients currently taking these combination pain medications and they should continue to take them as directed by their doctors. The risk of liver injury usually occurs in patients taking multiple products containing acetaminophen at one time and exceeding the maximum dose of 4,000 mg within a 24-hour period.