- According to the FDA, cases of severe hepatic injury with acetaminophen occurred in patients who exceeded the prescribed dose of an acetaminophen-containing product in a 24-hour period.
- Because of the risk for liver damage, the FDA is now asking clinicians not to prescribe combination prescription pain relievers containing more than 325 mg of acetaminophen per tablet, capsule, or other dosage unit, and to consider the amounts of both the acetaminophen and opioid components. The agency intends to begin proceedings soon to withdraw approval of prescription combination drug products containing more than 325 mg of acetaminophen per dosage unit that are still available on the market.
- In January 2011, the FDA asked that by January 14, 2014, manufacturers of prescription combination drugs containing acetaminophen would limit the amount of acetaminophen to not more than 325 mg in each tablet or capsule.
1. Consult Your GP
2. Avoid Self-medication
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FDA Safety Alert: Limit Prescription Acetaminophen Doses CME/CE
News Author: Megan Brooks CME Author: Laurie Barclay, MD
CME/CE Released: 02/13/2014 ; Valid for credit through 02/13/2015