The Food and Drug Administration is requiring manufacturers to place more prominent warning labels on certain over-the-counter drug products to alert consumers to the potential risks of liver injury from acetaminophen and stomach bleeding from NSAIDs.
The new labeling requirements are necessary, according to the FDA, because consumers may not be aware of the risks associated with overdosing on acetaminophen or NSAIDs. Additionally, because many OTC products contain acetaminophen or NSAIDs, consumers may not realize that they are taking more than one drug with these ingredients.
“We believe the new regulations are an important step to promoting the safe use of these drugs,” Matthew Holman, Ph.D., of the Division of Nonprescription Regulation Development in the FDA's Office of New Drugs, said during a press conference. The final rule was to be published in the Federal Register on April 29 and will go into effect 1 year later.
Under the new regulation, manufacturers must prominently display the term acetaminophen on the front of every OTC product containing the ingredient. The drug facts panel must include cautions in bold print at the beginning of the warning section advising consumers that “severe liver damage” may occur if they take more than the daily maximum, if they take the product with other drugs containing acetaminophen, or if they consume three or more alcoholic drinks per day while using the product.
The FDA is also requiring warnings for consumers with liver damage and those taking warfarin, advising them to consult a physician or pharmacist before using a product containing acetaminophen.
For NSAIDs, manufacturers will need to highlight the term NSAID on the front label of every product, because consumers may not know which specific drugs fall into this drug class, Dr. Holman said.
The drug facts panel on every OTC product containing an NSAID must include a bolded caution about the potential risks for “severe stomach bleeding,” especially for consumers aged 60 years or older, or for those who have had stomach ulcers or bleeding problems; who take a blood-thinning or steroid drug, or other drugs containing prescription or nonprescription NSAIDs; who have three or more alcoholic drinks per day while using the product; or who take more of the product than directed. The labels must also include a warning to consumers to stop taking the drug and consult a physician if they experience signs of stomach bleeding, such as feeling faint or vomiting blood.
New products that enter the market in the year after the rule goes into effect will also have to include a statement alerting consumers to the new warnings. This is important “because many consumers are familiar with these drugs and may not read the entire drug facts panel every time they use these drugs,” Dr. Holman said.
The final regulation is similar to a proposed rule that the FDA issued in December 2006. Since then, many manufacturers have voluntarily incorporated some of the elements of the new labeling requirements, but not all, he said.
The FDA is continuing to evaluate a number of issues that were originally raised in the proposed rule but are not addressed in the current labeling requirements, including the safe daily dose of acetaminophen for healthy users and those with chronic liver disease.
The final rule is on the FDA Web site at www.federalregister.gov/OFRUpload/OFRData/2009-09684_PI.pdf.