The U.S. Food & Drug Administration (FDA) is requiring aspirin manufacturers to strengthen their warnings about the possible side effects of taking aspirin such as liver damage, internal bleeding and even death. But what is all the controversy about? It's just aspirin, right? Wrong.

Aspirin can be deadly

While aspirin will generally provide a certain amount of relief for a headache, backache or stiff neck, the FDA says that too many consumers take too much aspirin – too frequently. It points to the many products on the market that are marketed for other ailments, but which also contain aspirin. So, if you're taking aspirin on a regular basis and also taking cold medication that contains aspirin (oftentimes, without even knowing it), then you're getting too much and may end up suffering severe liver damage and internal bleeding. In fact, too much may even cause death – and the FDA wants manufacturers to warn consumers of these risks.

FDA's new requirements

In April 2009, the FDA issued a final rule that requires manufactures of over the counter (OTC) pain relievers and fever reducers to revise their labeling to include warnings about these potential safety risks. Products covered by the rule include acetaminophen and a class of drugs known as the nonsteroidal anti-inflammatory drugs (NSAIDs) – which includes aspirin, ibuprofen, naproxen, and ketoprofen. OTC acetaminophen pain relievers include Tylenol and other brands. NSAIDS include aspirin (Bayer and other brands), Ibuprofin (Advil, Motrin and other brands), Naxopren (Aleve, Execdrin and other brands) and Ketoprofen.

The revised labeling, which must be completed by April 2010, applies to all OTC pain relievers and fever reducers, including those that contain one of these ingredients in combination with other ingredients, such as in cold medications. The FDA says that manufacturers must ensure that the active ingredients of these drugs are prominently displayed on the drug labels on both the packages and bottles. The labeling also must warn of the risks of stomach bleeding for NSAIDs and severe liver damage for acetaminophen.

Next steps

An FDA Advisory Committee meeting will meet in late June 2009 to discuss further steps the FDA could take to reduce the risk of liver damage associated with acetaminophen overdoses. To view a statement from the FDA, please click here.

If you or someone you know has suffered liver damage or died due to aspirin toxicity, contact an experienced products liability attorney to discuss your situation and evaluate your options.