The U.S. Food and Drug Administration (FDA) has asked doctors to stop prescribing combination drugs that contain more than 325 milligrams of acetaminophen per dosage unit, citing the risk of liver damage.
The FDA safety announcement issued on Tuesday said that limiting the quantity of acetaminophen in a dose will reduce the risk of inadvertent acetaminophen overdose, which can lead to liver damage, liver failure, liver transplant, and sometimes death, Reuters reports. In January 2011, the FDA asked manufacturers of combination drugs containing acetaminophen, sold under such trade names as Tylenol and Panadol, to limit acetaminophen doses to no more than 325 mg in each tablet or capsule by January 14, 2014, Reuters reports.
The FDA announcement said the agency plans to institute proceedings to withdraw approval of prescription combination drug products containing more than 325 mg of acetaminophen per dosage unit that remain on the market.
Acetaminophen – known as paracetamol outside the United States – is one of the most commonly used drugs in both prescription and over-the-counter products. In prescription pain medications, acetaminophen is often combined with pain relievers such as opioids. These medicines are prescribed for post-operative pain, pain from dental procedures, and pain from injuries. Acetaminophen is also a common ingredient in over-the counter cough and cold medicines and is sold as a single-ingredient pain reliever.
Patients taking both prescription and over-the-counter medicines may not be aware of how much acetaminophen they are taking in the course of a day and how easily they can exceed the maximum recommended dose. Inadvertent overdose from combination drugs containing acetaminophen accounts for nearly half of all cases of acetaminophen-related liver failure in the United States, according to the FDA.
The public interest journalism organization Pro Publica reports that in the last decade 1,500 people in the U.S. have died as a result of acetaminophen overdose. Pro Publica also reports that about a quarter of Americans routinely take more over-the-counter pain medicine than recommended and this is “particularly troublesome” in the case of acetaminophen because of the drug’s narrow safety margin. As little as 25 percent more than the recommended dose over a few days can cause liver damage, according to an FDA report.