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Jan. 13, 2011  

FDA’s Response to Preventable Acetaminophen Toxicity Problem is Dangerously Inadequate

Statement of Dr. Sidney Wolfe, Director, Public Citizen’s Health Research Group

The measures announced today by the Food and Drug Administration (FDA) concerning acetaminophen in prescription drug products are certainly a step forward, but they entirely fail to address the greater issue of over-the-counter (OTC) use of this drug and to implement strong recommendations made by three FDA advisory committees in June 2009 about this problem.

It is inexcusably poor judgment on the part of the FDA to have failed to take action concerning this major source of acetaminophen consumption and, consequently, acetaminophen toxicity.

According to FDA briefing documents presented at the 2009 meeting:

• More than 370 million bottles and packets, or 24.6 billion doses of acetaminophen were sold in 2008 in the U.S.; and
• Nearly 80 percent of this entire market is OTC medications.
In the Q and A posted today on the FDA’s website, the FDA stated the following:
Q11. Does this action limit the amount of acetaminophen in OTC acetaminophen products such as Tylenol?
o No. OTC acetaminophen products such as Tylenol are not affected by the new 325 mg limit at this time.
Q12. Will there be changes to the dosing of acetaminophen products marketed OTC?
o No, not at this time.

More than 18 months ago, at a meeting of FDA’s Drug Safety and Risk Management (of which I am a member), Over-the-Counter Drugs and Anesthetic Drugs Advisory Committees, the members overwhelmingly voted to recommend that the OTC dose of acetaminophen be lowered. This information is taken directly from the minutes of the June 29 and 30, 2009, advisory committee meeting:

Question 2 (Vote): Do you recommend that the maximum nonprescription single adult dose be limited to 650 mg? [This would, in effect, lower the maximum OTC pill size from 500 mg to 325 mg.]
o 12 members voted for A – Yes, I recommend this change and consider it a high priority
o 12 members voted for B – Yes, I recommend this change
o 13 members voted for C – No, I do not recommend this change

Thus 24 of the 37 members (65 percent) voted to lower the maximum OTC dose.

If the FDA needed to set a priority (and it is questionable if that was necessary) between acting on prescription or OTC products first, the agency should have first addressed the OTC category.

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