The U.S. Food and Drug Administration (FDA) has recently changed its guidelines for products containing acetaminophen to protect the public against the risk of acetaminophen-induced liver injury.
Earlier in the year the FDA issued a notice in the Federal Register which addressed its conclusion that, based on a “reevaluation of the relative risks and benefits of prescription acetaminophen products, fixed-combination prescription drugs containing more than 325 mg of acetaminophen per dosage unit (tablet or capsule) do not provide a sufficient margin of safety to protect the public against the serious risk of acetaminophen-induced liver injury.”
In furtherance of this conclusion, the FDA asked drug manufacturers to limit the maximum amount of acetaminophen per dosage unit to 325 mg and, for those products containing more than 325 mg of acetaminophen per dosage unit, to voluntarily submit aplication withdrawal requests to the FDA. Similarly, wholesalers have been asked to remove the product codes for such drugs from their ordering systems and return the items to the manufacturers.
Recently, the FDA also reminded healthcare practitioners to stop prescribing and pharmacists to stop dispensing combination drug products containing more than 325mg of acetaminophen per tablet or other dosage unit. If higher dosage prescriptions are received, the FDA recommends that pharmacists discuss a lower dosage product with the prescriber. The National Association of Boards of Pharmacy similarly recommends that “pharmacies no longer dispense combination drugs containing more than 325 mg of acetaminophen per dosage unit.”
If you have questions regarding the new prescribing guidelines or have other questions, please contact us here.