Acetaminophen Prescription Combination Drug Products With More Than 325 mg: FDA Statement – Recommendation to Discontinue

In light of all the recent news alerts and warnings about the use of acetaminophen and acetaminophen containing products, the FDA issued a recommendation of importance to pharmacists, prescribers, and patients.

FDA recommends that health care providers consider prescribing combination drug products that contain 325 mg or less of acetaminophen. 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. 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.

FDA, in its Medwatch Safety Alert, reports that: “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. Further, 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.”

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. More than half of manufacturers have voluntarily complied with 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, FDA intends to 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.

Boards of pharmacy have received inquiries from pharmacists about remaining stock of the higher dose acetaminophen and what procedures should be followed. The FDA recommendation notes that pharmacists are advised to contact prescribers and request a change in the prescription. If the prescriber is not willing to make the change in the prescription, unfortunately, there is no clear cut recommendation at this point as to whether to dispense the higher dose acetaminophen product. It would appear that the higher dose acetaminophen-containing products will be regarded by FDA as unapproved and delisted from FDA’s Approved Drug Products With Therapeutic Equivalence Evaluations (Orange Book). Until this occurs, pharmacists must make a judgment regarding continuing to dispense the higher dose acetaminophen-containing products in light of the FDA recommendation and concern for patient safety.