Abbott Laboratories’ Vicodin and Endo Pharmaceuticals Holdings Inc.’s Percocet will have limits on acetaminophen content to reduce liver injuries tied to overdoses, regulators said, stopping short of a recommended ban.
Prescription pain pills may contain no more than 325 milligrams of acetaminophen as of Jan. 14, 2014, the Food and Drug Administration said today in a notice. The medicines, which are among the most prescribed drugs in the U.S., also will carry a boxed warning on liver risks. The most common acetaminophen dose for prescription and over-the-counter drugs is 500 milligrams, the agency said.
The changes fall short of an advisory panel’s recommendations in June 2009 to ban the prescription combination products and limit acetaminophen doses in over-the-counter medicines. The FDA estimates that almost 200 million prescriptions for these drugs were dispensed in 2008.
“Lots of people have taken them and will continue to do so,” Sandra Kweder, deputy director of the FDA’s office of new drugs, said of the medicines on a conference call today with reporters. “Our goal is to make them safer.”
Regulators rejected a ban on combination prescription products because “we thought this was a more reasonable action to take and one that would not cause disruption,” Kweder said. Many patients aren’t aware that the prescription medicines they are taking contain acetaminophen because it is often abbreviated “APAP,” she said.
The FDA is still considering revising rules for over-the- counter drugs, which limit acetaminophen in most medicines to 500 milligrams, Kweder said. Extended-release drugs may contain more. The process for changing these rules is longer and more complicated than regulations for prescription drugs, she said.
Acetaminophen is contained in many cold and pain drugs marketed over the counter, including forms of Tylenol made by New Brunswick, New Jersey-based Johnson & Johnson. Because over- the-counter drugs aren’t affected by the current plan, acetaminophen sold at drugstores would be stronger than medicines prescribed by doctors in three years.
“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 health research at the Washington-based consumer group Public Citizen, in an e- mail.
Vicodin and its generic equivalents combining hydrocodone with acetaminophen are the most prescribed medicine in the U.S. with 128.2 million prescriptions in 2009, according to IMS Health Inc. in Norwalk, Connecticut.
“Abbott is evaluating the FDA’s guidance and will determine how best to comply,” said Elizabeth Hoff, a spokeswoman for the Abbott Park, Illinois-based drugmaker, in an e-mail. More than 99 percent of prescriptions for the combination are generic, she said.
Endo supports the FDA’s position and still considers educating patients to be the best way to prevent overdoses, said Kevin Wiggins, a spokesman for the Chadds Ford, Pennsylvania- based drugmaker. Endo’s version of Percocet with 325 milligrams of acetaminophen is the most popular strength, he said. The drug is also available as a generic.
Acetaminophen was the leading cause of acute liver failure in the U.S. from 1998 to 2003 with almost half of cases tied to accidental overdose. About 458 deaths, 26,000 hospitalizations and 56,000 emergency-room visits were tied to acetaminophen overdoses each year from 1990 to 1998, according to the FDA.
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