Acetaminophen overdose is one of the most common poisonings in the world. Hundreds of over-the-counter and prescription medicines contain acetaminophen, including common medications like Tylenol and Children’s liquid Tylenol.  As a result, many users accidentally ingest more than the recommended dose and suffer liver injury or liver failure. In response, dozens of Tylenol liver damage lawsuits have been filed accusing drug makers of failing to disclose this risk on product labels.

In an effort to combat the growing problem of acetaminophen overdose, the Food and Drug Administration recently issued a draft guidance with several recommendations for manufacturers of acetaminophen products like Children’s liquid Tylenol, designed to help minimize the risk to consumers of liver damage associated with the use of pediatric acetaminophen. The draft includes new labeling recommendations and recommendations for the dosage delivery device.

“FDA’s recommendations are designed to encourage safer use of these products by minimizing the potential for acetaminophen overdosing due to medication errors or accidental ingestion,” the agency noted in its October 2014 announcement. “These recommendations apply to both single ingredient and combination ingredient OTC liquid oral drug products that are labeled for use by children under 12 years of age and contain acetaminophen.”

The FDA’s draft guidance entitled “Over-the-Counter Pediatric Liquid Drug Products Containing Acetaminophen” is intended to help drug manufacturers, packagers, and labelers minimize the risk to consumers of acetaminophen-related liver damage associated with the use of nonprescription, also known as over-the-counter (OTC), acetaminophen-containing liquid drug products for children.

This guidance provides recommendations for acetaminophen concentration, container labels and carton labeling, packaging of such products, and recommendations regarding any associated delivery devices. FDA’s recommendations are designed to encourage safer use of these products by minimizing the potential for acetaminophen overdose due to medication errors or accidental ingestion.

Among the recommendations made by FDA:

• All single-ingredient acetaminophen oral liquids for pediatric use should have a concentration of 160 mg acetaminophen per 5 mL;
• For single-ingredient acetaminophen oral liquids, the statements “160 mg/5 mL” or “160 mg per 5 mL” should be prominently presented on the principal display panel of the container label and carton labeling immediately below or to the right of the active ingredient name (i.e., acetaminophen) and in the same font size as the active ingredient name;
• The PDP should clearly indicate the age range and units of age (e.g., months or years) as stated in the Drug Facts Panel under the heading “Directions”;
• The dosing directions in the Drugs Facts label should be provided only in milliliters (mL); and
• The product package should include an appropriate dosage delivery device, such as a calibrated and labeled oral syringe or dosing cup that’s calibrated in millileters (mL).

Acetaminophen Overdose Problems

The FDA’s recent major initiative to cut down on accidental acetaminophen overdose in adults has also been an effort to make prescribing acetaminophen safer for pediatric patients. This draft guidance is being issued consistent with FDA’s good guidance practices regulation. The draft guidance represents the FDA’s current thinking on addressing safety achieved through drug product design and labeling to minimize medication errors. The guidance’s recommendations, however, are voluntary.

The issuance of this draft guidance comes as Tylenol lawsuits involving allegations of serious liver damage continue to mount in federal court. A number of these claims were filed on behalf of children who were allegedly harmed by the acetaminophen contained in pediatric Tylenol products.