The Joint Meeting of the Drug Safety and Risk Management Advisory Committee with the Anesthetic and Life Support Drugs Advisory Committee and the Nonprescription Drugs Advisory Committee, which met June 29-30, 2009 to discuss steps to reduce acetaminophen-related overdoses and associated liver toxicity, has recommended that the FDA:
- Remove many acetaminophen-containing prescription analgesics from the market, including Vicodin (Abbot Laboratories), Percocet (Endo Pharmaceuticals), and Ultracet (Johnson & Johnson)
- Add strong warning language concerning the potential for liver damage to product labels for prescription drugs containing acetaminophen
- Lower the maximum recommended daily dose of over-the-counter acetaminophen from 4000 mg to 2600 mg
- Reduce the maximum single dose from 1000 mg to 650 mg
Cough and cold medicines and other acetaminophen-containing combination products will remain available.
If you would like additional information, you can review the briefing materials from this meeting here.
For additional news coverage on this topic, please visit the New York Times, Bloomberg News, and the Wall Street Journal. Please check back with PAINClinician regularly for clinical insights on the impact this recommendation has to the treatment of pain.
