FDA Issues Draft Guidance on Label Comprehension Studies and Calls for Revision to OTC Labels

The US Food and Drug Administration issued a draft guidance for industry, Label Comprehension Studies for Nonprescription Drug Products, in the May 1, 2009, Federal Register. The document provides guidance on the design of label comprehension studies. These studies are used to assess the extent to which consumers understand and apply information on nonprescription drug labels.

The draft guidance incorporates comments from a September 2006 meeting of the Nonprescription Drug Advisory Committee regarding the analysis and interpretation of consumer behavior studies as tied to nonprescription drugs.

Comments on the draft guidance can be submitted electronically at www.regulations.gov. Comments are due July 30, 2009.

In other labeling news, FDA issued a final rule on Apr. 28, 2009, that requires manufacturers of over-the-counter (OTC) pain relievers and fever reducers to include warnings about potential safety risks in their labeling. The rule applies to acetaminophen and nonsteroidal anti-inflammatory drugs such as aspirin, ibuprofen, naproxen, and ketoprofen. Manufacturers must prominently display the active ingredients of these types of drugs on both packages and bottles.

According to an FDA release, exceeding the dosage recommendation of acetaminophen as well as alcohol use with acetaminophen can increase the risks for severe liver damage. With nonsteroidal anti-inflammatory drugs, the risk of stomach bleeding may increase in those individuals also taking blood thinners or who exceed nonsteroidal anti-inflammatory dosage. Alcohol use is a concern with nonsteroidal anti-inflammatories as well.

Revised labeling must include the risks of stomach bleeding for nonsteroidal anti-inflammatories and severe liver damage for acetaminophen, according to the final rule. In addition, drugs containing acetaminophen must include a warning on the label that instructs consumers to check with their doctor before they take the blood-thinning drug warfarin.

The risks associated with the use of these products “need to be clearly identified on the label so that consumers taking these drugs are fully aware of the potential harm they can cause,” said Charles Ganley, M.D., director, FDA’s Office of Nonprescription Drugs in the Center for Drug Evaluation and Research, in an FDA release.

The final rule calls for manufacturers to revise product labels by May 28, 2010.