FDA Limits Acetaminophen/Opioid Combination Dosages

The FDA announced yesterday, 1/13/11, that they were asking manufacturers of prescription acetaminophen and opioid combination medications to 325 mg. per capsule, tablet or dosage unit, whatever may apply.  According to the FDA, they believe that by reducing the dosages of acetaminophen in these medications, it will reduce the risk of liver damage that may occur due to acetaminophen overdosing.  Liver injury from acetaminophen overdosing can lead to liver failure, liver transplant and even death.

Also in the FDA Safety Announcement released yesterday, the FDA states that a BOXED WARNING that highlights the potential for severe liver injury & a WARNING that highlights the potential for allergic reactions will be added to all drug products that contain acetaminophen.  These reactions may include:  swelling of the mouth, face and throat, breathing difficulties, itching or rashes.

Part of the release statement says:

These actions will help to reduce the risk of severe liver injury and allergic reactions associated with acetaminophen.

Acetaminophen is widely and effectively used in both prescription and over-the-counter (OTC) products to reduce pain and fever. It is one of the most commonly-used drugs in the United States. Examples of prescription products that contain acetaminophen include hydrocodone with acetaminophen (Vicodin, Lortab), and oxycodone with acetaminophen (Tylox, Percocet).

OTC products containing acetaminophen (e.g., Tylenol) are not affected by this action. Information about the potential for liver injury is already required on the label for OTC products containing acetaminophen. FDA is continuing to evaluate ways to reduce the risk of acetaminophen related liver injury from OTC products. Additional safety measures relating to OTC acetaminophen products will be taken through separate action, such as a rulemaking as part of the ongoing OTC monograph proceeding for internal analgesic drug products.

What do you think of this change?  How will this affect the chronic pain society?  Will people start taking more medication to try and get relief?  Let me know your thoughts in the comments! 

Please check out the links below for more information from the FDA on the acetaminophen information:

• List of Affected Prescription Acetaminophen Manufacturers
• List of Marketed Acetaminophen-Containing Prescription Products
• Questions and Answers about Prescription Acetaminophen Products to be Limited to 325 mg Per Dosage Unit
• FDA limits acetaminophen in prescription combination products; requires liver toxicity warnings