A consumer advocacy group is criticizing federal regulators for not extending new limits on acetaminophen to over-the-counter (OTC) drugs.
The Food and Drug Administration (FDA) announced Thursday it is restricting limits of acetaminophen in combination prescription painkillers to 325 milligrams (mg) because of their link to liver damage. Acetaminophen, a pain reliever found in thousands of over-the-counter products, is also combined with other ingredients in many ingredients, usually opioids such as codeine, oxycodone (Percocet) and hydrocodone (Vicodin). Some prescription products can contain up to 750 mg — double of the new FDA ceiling.
The FDA said it sought the new limits because acetaminophen overdoses are associated with serious liver damage.
"There is no immediate danger to patients who take these combination pain medications and they should continue to take them as directed by their healthcare provider," said Sandra Kweder, deputy director of the Office of New Drugs in FDA's Center for Drug Evaluation and Research. "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 mg within a 24-hour period."
A consumer watchdog says the new guidelines ignore the dangers of OTC products, which make up about 80 percent of acetaminophen's market.
“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 Sidney Wolfe, director of Public Citizen’s Health Research Group.
However, the agency is still considering new limits on OTC products, an FDA spokeswoman said.
“There are more complexities in the OTCs and the process of rulemaking occurs over a longer timeframe,” the spokeswoman said.
Higher-dose prescription combination acetaminophen products will be phased out over three years, and the FDA said the new guidelines should not create a shortage of pain medication. The agency is also recommending that boxed warnings — the strongest possible caution for prescription drugs — be added to all acetaminophen prescription products.