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FDA Orders Cap on Strength of Prescription Painkillers Containing Acetaminophen

By January 20, 2011July 23rd, 2019Dangerous Drugs

The U.S. Food and Drug Administration recently made an order that should get attention from ordinary Americans as well as dangerous drug attorneys like me. As the Washington Post reported Jan. 13, the FDA on that day said it has asked drug makers to restrict the strength of products containing the painkiller acetaminophen. Acetaminophen is the active ingredient in Tylenol and is also used in prescription drugs such as Vicodin or Percocet, which combine it with opioid painkillers. The FDA has restricted it to no more than 325 mg per dose out of concerns about liver toxicity from overuse. That’s a reduction for many prescription painkillers, which can contain as many as 750 mg of acetaminophen.
Acetaminophen’s negative effect on the liver has been understood for years, but a 2005 study shed more light on the issue. That study found that acetaminophen was the most common cause of liver failure in the United States, with nearly half of all cases resulting from an accidental overdose. Patients can accidentally overdose if they take too many products that contain acetaminophen at once, exceed the maximum dose or combine acetaminophen with alcohol. An FDA statement issued with the safety alert noted that acetaminophen overdoses caused an estimated 450 deaths per year between 1990 and 1998. The labels of prescription drugs containing acetaminophen must also carry a “black box” warning about the potential for liver injury, and doctors were asked to advise patients to limit their doses to no more than 4,000 mg a day.
The move does not affect over-the-counter painkillers containing acetaminophen — just their prescription-only cousins. This has raised criticism from public safety groups such as Public Citizen, and also concerns me as a defective drug lawyer. Over-the-counter drugs can contain high levels of acetaminophen too. Extra-strength Tylenol, for example, contains 500 mg per pill, which is above the 325-mg limit for prescription drugs. Patients are instructed to take two extra-strength Tylenols every four to six hours, which could mean as much as 6,000 mg in a 24-hour period. That’s over the 4,000 mg maximum dose in the instructions for doctors. And this is assuming that patients pay attention to dosing information, something that is not likely to always be true. The FDA should be commended for this move, but we hope it follows with action on OTC medicines.

Based in St. Louis and southern Illinois, Carey, Danis & Lowe represents clients from around the United States who were seriously injured or lost a family member because of a dangerous drug. Our pharmaceutical liability attorneys focus our practice on helping such people prove that the drug is responsible for their injuries, medical bills and other personal and financial costs. All drug manufacturers have a legal obligation to make sure their products are safe, or warn patients about potential risks that can’t be avoided. Failure to do this leaves the company liable for any injuries, financial costs or other harm to patients. We handle claims from individuals as well as class-action claims that bring together many people who were harmed by the same defective product or failure to warn.
If you or someone you love was harmed by a medication you thought you could trust, you should call Carey, Danis & Lowe for help. To set up a free consultation, send us a message online or call 1-877-678-3400 today.