The Food and Drug Administration (FDA) is now restricting the amount of acetaminophen that can be included in a prescription combination of opioid and acetaminophen to 325 mg per tablet, capsule, or other dosage unit. Examples of such combination pain-relieving products are oxycodone with acetaminophen (Percocet and others) and hydrocodone with acetaminophen (Vicodin and others). Currently these combination products may contain as much as 750 mg of acetaminophen per dose (as in Vicodin ES). The purpose of restricting the acetaminophen dose is to decrease the risk of accidental overdose and the incidence of acute liver failure. Patients with acute liver failure may require liver transplantation or even die.
To further help highlight the risk of severe liver damage from acetaminophen overdosage, the FDA is requiring a black box warning on the labeling of these products. This restriction of acetaminophen doesn't apply to over-the-counter preparations, even though some may contain more acetaminophen per dosage unit, as is the case with Extra Strength Tylenol, which contains 500 mg per tablet.
To read the FDA Drug Safety Communication, go to http://1.usa.gov/gt4pka.
For more information on acetaminophen overdosage and the new FDA regulations, read Nursing Information on Acetaminophen Overdosage at http://links.lww.com/AJN/A23.