FDA Further Restricts Amount of Tylenol in Pain Products

FDA recommends physicians stop prescribing and dispensing prescription combination drug products with more than 325 mg of acetaminophen to protect consumers, including pain products that contain Tylenol and opioids.

The Food and Drug Administration has asked physicians to stop prescribing combination pain products that contain more than 325 mg/dose of acetaminophen. By limiting the amount of acetaminophen (Tylenol) prescribed, the FDA is hoping to lessen the risk of  liver injury due to a accidental acetaminophen overdose.

According to the FDA, "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 risks for liver injury." The agency recommends, therefore, that "health care providers consider prescribing combination drug products that contain 325 mg or less of acetaminophen. We also recommend 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." 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. "We requested this action to protect consumers from the risk of severe liver damage which can result from taking too much acetaminophen," noted the agency. 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 our 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 intends recommend withdrawal of all 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.

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.

Acetaminophen is also widely used as an over-the-counter (OTC) pain and fever medication, and is often combined with other ingredients, such as cough and cold ingredients. The FDA  will address OTC acetaminophen products in another regulatory action. Many consumers are often unaware that many products (both prescription and OTC) contain acetaminophen, making it easy to accidentally take too much.

Updated on: 01/15/14