Magazine article Clinical Psychiatry News

Acetaminophen, NSAIDs Get Stronger Warning Labels for Liver Injury Risks

Magazine article Clinical Psychiatry News

Acetaminophen, NSAIDs Get Stronger Warning Labels for Liver Injury Risks

Article excerpt

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 nonsteroidal anti-inflammatory drugs.

The new labeling requirements are necessary, according to the FDA, because many consumers may not be aware of the risks associated with overdosing of acetaminophen or NSAIDs. In addition, because many OTC products contain acetaminophen or NSAIDs, consumers may not realize that they are taking more than one drug with these ingredients.

"The new regulations are an important step to promoting the safe use of these drugs," Matthew Holman, Ph.D., deputy director of the Division of Nonprescription Regulation Development in the FDA's Office of New Drugs, said during a press conference.

The final rule will go into effect next year.

Under the new regulation, manufacturers must prominently display the term acetaminophen on the front of every OTC product containing the ingredient. On the drug facts panel, the products will also have to 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 maximum number of daily dosage units within 24 hours, if they take it with other drugs containing acetaminophen, and if they consume three or more alcoholic drinks a day while using the product.

The FDA is also requiring warnings directed at consumers with liver damage and those taking the drug warfarin advising them to consult a physician or pharmacist before using a product containing acetaminophen.

For NSAID products, manufacturers will need to highlight the term "NSAID" on the front label of every product. This will alert consumers to the fact that they are taking an NSAID, since many may not know which specific drugs fall into this drug class, Dr. …

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