Charlottesville, Virginia


Email Greg Webb Greg Webb on LinkedIn Greg Webb on Facebook
Greg Webb
Greg Webb
Attorney • (800) 451-1288

Consumers take note! – Acetaminophen Side Effects Still A Multifaceted Issue

Comments Off

It is known that Acetaminophen is the active ingredient in many over-the-counter pain and fever relieving products. It is less well known that Acetaminophen poisoning may result in “an estimated 56,000 injuries, 25,000 hospitalizations, and 450 deaths every year.” (Recommendations for FDA Interventions to Decrease the Occurrence of Acetaminophen Hepatotoxicity, prepared for Janet Woodcock, MD, by the Acetaminophen Hepatotoxicity Working Group, U.S. Food and Drug Administration, February 26, 2008).

Medical professionals have concluded that long-term use, or large doses of the drug, can damage the liver and also may lead to liver failure or even death. Other published side effects of Acetaminophen may include:

  • Acute liver toxicity
  • Allergic reactions (swelling, difficulty breathing, closing of throat, and others)
  • Abdominal pain
  • Nausea
  • Unusual bleeding or bruising.

Additionally, Acetaminophen could boost blood pressure for some, according to a recent Swiss trial discussed in the February 2011 Harvard Heart Letter.

In the opinion of the U.S. Acute Liver Failure Study Group, formed in 1996 and funded by the National Institutes of Health (NIH), the Food and Drug Administration, and other public and private health organizations, acetaminophen poisoning is responsible for 50 % of liver failure occurring, with the next most common causes being drug reactions (12%) and viral hepatitis (11%), hepatitis B (7%) and A (4%).

In June 2009, an advisory panel to the Food and Drug Administration recommended banning Acetaminophen, but in a recent decision by the FDA, prescription drugs containing Acetaminophen “will have limits on acetaminophen content to reduce liver injuries tied to overdoses, regulators said, stopping short of a recommended ban.” According to the FDA, an article published in Bloomberg News by Catherine Larkin (January 13, 2011), “Prescription pain pills may contain no more than 325 milligrams of acetaminophen as of Jan. 14, 2014.” The FDA estimates that as many as 200 million prescriptions for Acetaminophen containing drugs were written in 2008. According to an FDA official, Sandra Kweder, “The FDA is still considering revising rules for over-the-counter drugs, which limit acetaminophen in most medicines to 500 milligrams,” Larkin’s article notes.