The FDA notified healthcare professionals that it asked drug manufacturers to limit the strength of acetaminophen in prescription drug products, mostly combinations of acetaminophen with opioids, to 325 mg per dosage form, in an aim to help reduce the risk of severe liver injury and allergic reactions associated with prolonged acetaminophen use, and hence making these products safer for the patient. Consequently, a Boxed Warning stating the potential for severe liver injury and a Warning stating the potential for allergic reactions will be added to the label of all acetaminophen prescription drug products.
No drug shortages are to be expected since a 3-year implementation period has been given which should allow sufficient time for the necessary reformulations.
Acetaminophen is one of the most commonly used drugs and is widely effective in the management of pain and fever. Examples of prescription products affected by this include those containing oxycodone with acetaminophen and hydrocodone with acetaminophen. Acetaminophen containing OTC products are not affected by this action, since warnings about the potential for liver injury is already required on their labels. The FDA continues to evaluate ways to reduce the risk of acetaminophen-related liver injury from OTC products.
Meanwhile, Healthcare professionals are reminded to advice patients not to exceed the maximum total daily dose of 4 grams/day of acetaminophen, and to avoid alcohol while taking acetaminophen containing medications. They were also advised to inform patients that there is no immediate danger to patients taking these combination medications, and they should continue taking them as directed by their healthcare provider.