The FDA is recommending health care professionals discontinue prescribing and dispensing prescription combination drug products that contain more than 325 milligrams of acetaminophen (Tylenol) per tablet, capsule, or other dosage unit. There are no available data to show that taking more than 325 mg of acetaminophen per dosage unit provides additional benefit that outweighs the added risk for liver injury. Limiting the amount of acetaminophen per dosage unit will reduce the risk of severe liver injury from inadvertent acetaminophen overdose, which can lead to liver failure, liver transplant, and death.
The FDA recommends that health care providers consider prescribing combination drug products that contain 325 mg or less of acetaminophen. When a pharmacist receives a prescription for a combination product with more than 325 mg of acetaminophen per dosage unit the FDA recommends that the pharmacist contact the prescriber to discuss a product with a lower dose of acetaminophen. A two tablet or two capsule dose may still be prescribed, if appropriate. In that case, the total dose of acetaminophen would be 650 mg (the amount in two 325 mg dosage units). When making individual dosing determinations, health care providers should always consider the amounts of both the acetaminophen and the opioid components in the prescription combination drug product.
In January 2011, the FDA asked manufacturers of prescription combination drug products containing acetaminophen to limit the amount of acetaminophen to no more than 325 mg in each tablet or capsule by January 14, 2014. The FDA requested this action to protect consumers from the risk of severe liver damage that can result from taking too much acetaminophen. This category of prescription drugs combines acetaminophen with another ingredient intended to treat pain (most often an opioid), and these products are commonly prescribed to consumers for pain, such as pain from acute injuries, post-operative pain, or pain following dental procedures. More than half of manufacturers have voluntarily complied with the FDA’s request. However, some prescription combination drug products containing more than 325 mg of acetaminophen per dosage unit remain available. In the near future, the FDA will institute proceedings to withdraw approval of prescription combination drug products containing more than 325 mg of acetaminophen per dosage unit that remain on the market.
Cases of severe liver injury with acetaminophen have 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.
More than 600 medications, both prescription and over-the-counter (OTC) medications, contain the active ingredient acetaminophen to help relieve pain and reduce fever. Taken carefully and correctly, these medicines can be safe and effective. But taking too much acetaminophen can lead to severe liver damage.
Acetaminophen is a common medication for relieving mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches and to reduce fever. Inadvertent overdose from prescription combination drugs containing acetaminophen accounts for nearly half of all cases of acetaminophen-related liver failure in the United States, some of which result in liver transplant or death.
See the FDA Announcement
See also Medical Law Perspectives, January 2014 Report: Prescription Painkillers: Risks for Patients, Pharmacists, and Physicians
See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication