Published on:

FDA Issues Warning about Acetaminophen in Combination Drugs

The U.S. Food and Drug Administration (FDA) issued a warning this month to health care professionals asking them to discontinue prescribing prescription combinations drugs that contain more than 325 milligrams of acetaminophen as more than that amount can cause liver damage.

According to an article on CNN.com, acetaminophen is often used in prescription medications such as oxycodone (also known as Percocet), hydrocodone (also known as Vicodin), and codeine (such as Tylenol with Codeine). But consumers may not be aware that these prescription products, considered combination drugs, can contain acetaminophen. A patient who may need more relief from pain could take an additional dose of over-the-counter (OTC) acetaminophen. The FDA explained, “Many consumers are often unaware that many products (both prescription and OTC) contain acetaminophen, making it easy to accidentally take too much.”

The FDA asked manufacturers to limit the amount of acetaminophen in prescription combination drugs to 325 mg per capsule or tablet by January 2014. According to the article, more than half agreed, but some combination drugs with higher amounts remain on the market. As a result, the FDA will begin the process of withdrawing approval of prescription combination drugs from manufacturers that have not complied.

According to the FDA, the recommended maximum of acetaminophen for adults is 4,000 mg per day. Consumers should not take more than the prescribed dose. The FDA recommends consumers avoid taking more than one acetaminophen product at a time. There is no data to show that taking more than that amount provides enough benefit to outweigh the risk of liver damage.