FDA Sets Limit on Acetaminophen Dose due to Liver Damage

The Food & Drug Administration (FDA) is recommending that health care professionals stop prescribing and dispensing prescription combination drug products that contain more than 325 milligrams (mg) of acetaminophen per tablet, capsule or other dosage unit.

WHY:

  1. Acetaminophen is also widely used as an over-the-counter (OTC) pain and fever medication. It is often combined with other ingredients, such as cough and cold ingredients. Many consumers are often unaware that many products (both prescription and OTC) contain acetaminophen, making it easy to accidentally take too much.
  2. There are no available information, studies to show that taking more than 325 mg of acetaminophen per dosage unit provides added benefit that outweighs the added risks for liver injury. Further, limiting the amount of acetaminophen per dosage unit will cut the risk of severe liver injury from inadvertent acetaminophen overdose, which can lead to liver failure, liver transplant, and death.

PATIENT SAFETY ISSUE: LIVER DAMAGE WITH ACETAMINOPHEN
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, USUALLY more than 4000 milligrams (4 grams) daily dose in a 24 hr period;
• took more than one acetaminophen-containing product at the same time; or
• drank alcohol while taking acetaminophen products.

In January 2011 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. FDA requested this action to protect consumers from the risk of severe liver damage which can result from taking too much acetaminophen. This class 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 request. However, some prescription combination drug products containing more than 325 mg of acetaminophen per dosage unit remain available. In the near future FDA intends to begin proceedings to withdraw approval of prescription combination drug products containing more than 325 mg of acetaminophen per dosage unit that remain on the market.

FDA’S RECOMMENDATION:

  1. FDA recommends that health care providers consider prescribing combination drug products that contain 325 mg or less of acetaminophen.
  2. FDA also recommends that when a pharmacist receives a prescription for a combination product with more than 325 mg of acetaminophen per dosage unit that they contact the prescriber to discuss a product with a lower dose of acetaminophen.
  3. 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).
  4. 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.