FDA issues warning for acetaminophen doses over 325mg

The Food and Drug Administration has asked doctors not to prescribe combination drugs containing more than 325 mg of acetaminophen, as higher doses increase the risk of liver damage.

In 2011, the FDA had asked manufacturers of prescription combination drugs, medication containing two or more drugs, to stop manufacturing drugs containing more than 325 mg of acetaminophen. While more than half of the manufacturers complied, there are still drugs available continuing a high dosage of acetaminophen.

"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 FDA said in a statement Tuesday.

The FDA recommends that pharmacists who receive prescriptions for combination drugs containing more than 325 mg of acetaminophen contact the doctor in question and recommend a drug with a lower dosage.

Acetaminophen has caused liver damage in patients who took more than the prescribed dose in a 24-hour period, took more than one acetaminophen-containing drug at the same time, or drank alcohol while taking such drugs. Many opioids are given in combination with acetaminophen for patients with acute pain, post-operative pain, or pain following dental procedures.

Acetaminophen is also available in over-the-counter fever and pain medication. But the FDA said they will issue a separate advisory for such drugs at a later time.

[FDA]