Product Liability

Group questions FDA’s reluctance to limit acetaminophen in OTC drugs

Last month the Food and Drug Administration (FDA) asked makers of prescription acetaminophen drugs to limit the amount of acetaminophen to no more than 325 milligrams (mg) in each tablet or capsule, and to update their safety labels to include a black box warning for the risk of severe liver injury. While the watchdog group Public Citizen calls this move by the federal agency a “step forward,” it is asking the FDA why it stopped short in addressing the greater issue of over-the-counter (OTC) use of acetaminophen. After all, an FDA advisory committee in June 2009 offered strong recommendations concerning OTC acetaminophen drugs, such as the popular brands Tylenol and Midol.

“It is inexcusably poor judgment on the part of the FDA to have failed to take action concerning this major source of acetaminophen consumption and, consequently, acetaminophen toxicity,” said Dr. Sidney Wolfe, Director of Public Citizen’s Health Research Group, in a statement.

More than 370 million bottles and packets, or 24.6 billion doses, of acetaminophen were sold in the U.S. in 2008, and nearly 80 percent of those sales were sold over-the-counter. Prescription drugs affected by the FDA’s criteria include codeine (Tylenol with Codeine), oxycodone (Percocet), and hydrocodone (Vicodin).

OTC medications do not exceed the 325 mg of acetaminophen limit per tablet the criteria the FDA imposed, and despite strong recommendations from the advisory committee to lower the dose of OTC acetaminophen drugs from 500 mg per pill to 325 mg per pill because of the harm it can cause to the liver, the FDA opted to leave OTC drug dosing the same.

“If the FDA needed to set a priority (and it is questionable if that was necessary) between acting on prescription or OTC products first, the agency should have first addressed the OTC category,” said Dr. Wolfe, who is also a member of the advisory panel that provided recommendations to the FDA on acetaminophen products.

While not specifically addressing the omission of regulations on OTC acetaminophen products, at the time of the original announcement about the new limits on prescription products, Sandra Kweder, M.D., deputy director of the Office of New Drugs in FDA’s Center for Drug Evaluation and Research (CDER), said in a press release, “The risk of liver injury primarily occurs when patients take multiple products containing acetaminophen at one time and exceed the current maximum dose of 4,000 milligrams within a 24-hour period.”