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FDA to Curb Consumption of Acetaminophen in Prescription Painkillers

ABC World News reported, “The FDA launched a major crackdown against the overuse of one of the most popular painkillers on the market, acetaminophen.”

Bloomberg News reports, “Prescription pain pills may contain no more than 325 milligrams of acetaminophen as of Jan. 14, 2014, the Food and Drug Administration said.” The medicines “also will carry a boxed warning on liver risks.” The FDA said the “most common acetaminophen dose for prescription and over-the-counter drugs is 500 milligrams.”

The AP reports that FDA officials said “the labeling on prescription drugs often does not make it clear that they contain acetaminophen, instead using abbreviations for the ingredient like ‘APAP.’”

The New York Times reports Federal drug regulators “have tried for decades to cut down on acetaminophen’s toll, but little changed until June 2009, when the FDA’s panel of experts voted by a bare majority to call for a ban on drugs that combine acetaminophen with narcotics.”

Liver failure from overdose a risk. The Washington Post reports the FDA’s Sandra Kweder said, “The FDA is taking this action to make prescription combination pain medications containing acetaminophen safer for patients to use. … Overdose from prescription combination products containing acetaminophen account for nearly half of all cases of acetaminophen-related liver failure in the United States, many of which result in liver transplant or death.”

AFP reported, “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,” Kweder added. However, “There is no immediate danger to patients who take these combination pain medications and they should continue to take them as directed by their health care provider.”

The Los Angeles Times reports, “Acetaminophen is valued as a pain reliever in part because, unlike other common analgesics such as aspirin, ibuprofen and naproxen, it does not cause gastric bleeding or other stomach discomfort.” But regulators “have long worried about liver damage from the drug particularly when taken in excess of a 4,000 milligram daily limit, or with alcohol.” The “elimination of versions of drugs containing up to 750 milligrams of acetaminophen will be phased in over three years and is not expected to create shortages of pain medication.”

Guidelines don’t go far enough, some argue. The Hill “Healthwatch” blog reported a consumer watchdog criticized that “the new guidelines ignore the dangers of” over-the-counter “products, which make up about 80 percent of acetaminophen’s market.” Sidney Wolfe of the Public Citizen’s Health Research Group said, “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.

From the American Association for Justice press release.

Bob Kraft

I am a Dallas, Texas lawyer who has had the privilege of helping thousands of clients since 1971 in the areas of Personal Injury law and Social Security Disability.

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The title of this blog reflects my attitude toward those government agencies and insurance companies that routinely mistreat injured or disabled people. As a Dallas, Texas lawyer, I've spent more than 45 years trying to help those poor folk, and I have been frustrated daily by the actions of the people on the other side of their claims. (Sorry if I offended you...)

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