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Outrage of the Month: FDA’s Reckless Inaction Regarding Over-the-Counter Acetaminophen

February 2014

Michael Carome, M.D.

Last month, the Food and Drug Administration (FDA) issued a public health safety alert regarding prescription combination drug products containing acetaminophen (the active ingredient in Tylenol).[1] This alert provided another reminder of the agency’s unacceptable, years-long failure to take appropriate regulatory action to reduce preventable liver injury related to the use of over-the counter (OTC) high-dose acetaminophen products.

More than four and a half years ago in June 2009, the FDA convened a joint meeting of three advisory committees — the Drug Safety and Risk Management Advisory Committee, the Anesthetic and Life Support Drugs Advisory Committee, and the Nonprescription Drugs Advisory Committee — to discuss and make recommendations regarding the serious public health problem of liver injury related to the use of acetaminophen in both OTC and prescription products.[2]

The members of the advisory committees delivered a clear message to the FDA when they overwhelmingly voted 24 to 13 to recommend, among other things, that the dose of all OTC acetaminophen products be lowered to a maximum of 325 milligrams (mg) per pill (which would limit the maximum indicated nonprescription dose to 650 mg).[3] The most commonly sold dose of acetaminophen — dubbed “extra strength” — is currently the 500 milligrams per pill. Twelve members urged the FDA to consider such action a high priority.[4] Among the factors that formed the basis for these recommendations were the following:

  • More than 370 million bottles and packets, or 24.6 billion doses, of acetaminophen were sold in the U.S. in 2008;[5]
  • OTC medications represent nearly 80 percent of this entire market;[6] and
  • Acetaminophen is the leading cause of acute liver failure in the U.S., with almost half of such cases due to accidental overdose.[7]

Disturbingly, the FDA has yet to take action to limit the OTC dose of acetaminophen products to 325 mg per pill or other unit dose. Instead, the agency has focused on prescription combination products that contain acetaminophen and another active ingredient, typically a narcotic pain reliever such as codeine, oxycodone or hydrocodone.

The FDA’s first action to limit the dosage of acetaminophen in any product didn’t come until January 2011, when the agency asked manufacturers to voluntarily stop making prescription combination drugs containing doses of acetaminophen exceeding 325 mg per tablet, capsule or other dosage unit within two years.[8] In taking this action, the FDA cited a lack of evidence showing that higher amounts of acetaminophen doses provide additional benefit that would outweigh the added risks for liver injury.

Most recently, on Jan. 14, 2014, the FDA advised health care professionals to stop prescribing and dispensing prescription medications containing high doses of acetaminophen (TYLENOL) combined with other active ingredients.[9] The agency noted that more than half of manufacturers have voluntarily complied with the agency’s 2011 request to limit the dose of acetaminophen in prescription combination products to 325 mg per pill, implying that many have not. The FDA also noted in its most recent alert that “FDA will address OTC acetaminophen products in another regulatory action,” without signaling what the action would be or when it would occur.[10]

The FDA’s dangerous foot-dragging with respect to limiting the dose of OTC acetaminophen almost certainly has resulted in preventable cases of liver failure due to inadvertent overdosing of these products over the past several years. Such inaction by one of the lead agencies of the U.S. Public Health Service is inexcusable.

References

[1] Food and Drug Administration. Acetaminophen prescription combination drug products with more than 325 mg: FDA statement – recommendation to discontinue prescribing and dispensing. January 14, 2014. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm381650.htm. Accessed January 15, 2014.

[2] Food and Drug Administration. Announcement for the joint meeting of the Drug Safety and Risk Management Advisory Committee, the Nonprescription Drugs Advisory Committee, and the Anesthetic and Life Support Drugs Advisory Committee on June 29 and 30, 2009. http://www.fda.gov/AdvisoryCommittees/Calendar/ucm143083.htm. Accessed January 15, 2014.

[3] Food and Drug Administration. Minutes of the joint meeting of the Drug Safety and Risk Management Advisory Committee, the Nonprescription Drugs Advisory Committee, and the Anesthetic and Life Support Drugs Advisory Committee on June 29 and 30, 2009. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/DrugSafetyandRiskManagementAdvisoryCommittee/UCM179888.pdf. Accessed January 15, 2014.

[4] Ibid.

[5] Public Citizen. FDA’s response to preventable acetaminophen toxicity problem is dangerously inadequate. Statement of Dr. Sidney Wolfe, Director, Public Citizen’s Health Research Group. January 13, 2011. http://www.citizen.org/pressroom/pressroomredirect.cfm?ID=3256. Accessed January 15, 2014.

[6] Ibid.

[7] Food and Drug Administration. Acetaminophen overdose and liver injury — background and options for reducing injury. Prepared for the joint meeting of the Drug Safety and Risk Management Advisory Committee, the Nonprescription Drugs Advisory Committee, and the Anesthetic and Life Support Drugs Advisory Committee on June 29 and 30, 2009. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/DrugSafetyandRiskManagementAdvisoryCommittee/UCM164897.pdf. Accessed January 15, 2014.

[8] Food and Drug Administration. Acetaminophen prescription products limited to 325 mg per dosage unit: drug safety communication. January 13, 2011. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm239955.htm. Access January 15, 2014.

[9] Food and Drug Administration. Acetaminophen prescription combination drug products with more than 325 mg: FDA statement – recommendation to discontinue prescribing and dispensing. January 14, 2014. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm381650.htm. Accessed January 15, 2014.

[10] Ibid.

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