Voluntary Acetaminophen Labeling Revisions Include Overdose Warning

McNeil Consumer & Specialty Pharmaceuticals and Bayer Consumer Care are revising acetaminophen product labeling to add a distinct "overdose warning," the companies say in materials submitted to FDA's Nonprescription Drugs Advisory Committee.

The new overdose warning for McNeil's Tylenol products states: "Taking more than the recommended dose (overdose) could cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms."

New labeling for Bayer's acetaminophen-containing products under the Midol , Alka-Seltzer Plus and Vanquish brands contains similar language, according to ¹ Bayer's briefing materials on analgesic safety.

Previously, labeling for the McNeil and Bayer products included statements about getting medical help and the importance of quick medical attention for an overdose after the statement "Keep out of reach of children." The new OD warning on both companies' products is now separate from the "Keep out of reach of children" advisory. In addition, a reference to the overdose warning follows a statement advising users against taking more than the recommended amount.

In ² McNeil's briefing materials on acetaminophen, the company points out the new OD warning appears on the outer carton and bottle of Tylenol single-ingredient products and the outer carton of Tylenol cough/cold combination products covered under a monograph.

Tylenol cough/cold products with the new labeling began shipping in July; single-ingredient SKUs with the new packaging will begin shipping soon. The company also has requested labeling revisions for Tylenol Arthritis Extended Pain Relief (650 mg), which is marketed under an approved NDA.

McNeil's materials point to several other language and format labeling revisions. For instance, the firm added active ingredient names to the principal display panel of combination products "in prominent type size."

The "active ingredients" section of "Drug Facts" labeling is now highlighted in yellow, and the outer carton contains a flag announcing "new label information" in the PDP upper corner. The flag "will be included for a minimum of six months," McNeil says.

The statement "do not use with other medicines containing acetaminophen" has been added to the PDP on the single-ingredient bottle label, which formerly contained the statement only as part of the label text. For combination products, the same phrase has been added to the side flap of the box, and the words "contains acetaminophen" are on all blister cards.

NDAC and members from five other FDA advisory panels will meet Sept. 19 to consider whether hepatotoxicity concerns surrounding acetaminophen warrant new labeling requirements.

While both McNeil and Bayer have proactively made recent label changes to their acetaminophen products, the companies hold divergent opinions on the need for additional modifications. The Tylenol marketer maintains the analgesic is safe for use at labeled, recommended doses (see ³ (Also see "Acetaminophen Dose Reduction Public Health Damage Cited By McNeil" - Pink Sheet, 16 Sep, 2002.)). However, Bayer is pushing for a GI warning on acetaminophen products.

Bayer tells NDAC it revised labeling to highlight specific risks associated with multiple acetaminophen-containing product use. Both Bayer and McNeil said their new labeling is based on revisions suggested by the Consumer Healthcare Products Association.

CHPA's guidelines call for emphasizing the presence of acetaminophen on the PDP, color highlighting of the ingredient on the "Drug Facts" label, flagging the label, and adding warnings about overdose and use with other acetaminophen products, according to Bayer, which initiated the labeling revisions in April.

The trade association's recommendations were drafted but never finalized before companies such as McNeil and Bayer moved ahead with their own labeling changes, CHPA said, adding it has no plans to finalize or formally adopt the labeling revisions.

McNeil says it revised product labeling "to direct the attention and enhance awareness of consumers to key label information that may reduce the occurrence of excessive acetaminophen exposure."

The company points to data from a September 2001 telephone survey of consumer habits and practices that found consumers "generally were not aware that cough/ cold products also contained an analgesic." However, use of an analgesic trade name, such as Tylenol, "within the name of a combination product increases consumer awareness of the analgesic component of these combination products," the firm says.