On Tuesday, the U.S. Food and Drug Administration (FDA) ruled OTC pain relievers such as Advil and Tylenol need to carry stronger warnings.
The makers of over-the-counter (OTC) pain relievers and fever reducers must revise their labeling to include bolder warnings about potential safety risks such as liver damage and internal bleeding, associated with the use of these drugs.
The FDA action includes acetaminophen, and anti-inflammatory drugs (NSAIDs). NSAIDs include aspirin, ibuprofen, ketoprofen and naproxen. While acetaminophen is in a class by itself.
The revised labeling applies to all OTC pain relievers and reducers, including those that contain one of these ingredients in combination with other ingredients, such as cold medicines containing pain relievers or fever relievers.
“The labeling on these products need to clearly identify and inform consumers of the associated risks of taking these drugs and the potential harm they may cause. It is important users know how to take these medications safely to reduce their risk, said Charles Ganley, M.D., director, FDA’s Office of Nonprescription Drugs.
Under the final rule, manufacturers must prominently display the contained active ingredients on the bottle label and also on the packaging. The labeling must also warn consumers of the risk of stomach bleeding associated with NSAIDs and severe liver damage associated with acetaminophen.
The new rules, first proposed in 2006, also apply to generic versions of the drugs and other OTC products.
While the risks associated with this class of drugs has been known for years, the FDA says it is important to better highlight them for consumers, who could unknowingly take multiple products that contain acetaminophen.
The new warnings will also highlight the increased risk of liver damage with acetaminophen in consumers who consume three or more alcoholic drinks each day. They also call on consumers taking the drug warafin, a widely used blood thinner, warning them to consult their doctor before taking products containing acetaminophen.
The new rule requires all manufacturers to revise their product labels within one year of today’s date.
In late June an FDA Advisory Committee will meet to discuss further actions the agency can take to reduce the risk of liver damage associated with acetaminophen overdoses. #