National Consumers League Urges FDA to Reject Petition Seeking Autism Warning on Children’s Acetaminophen
Media Contact: Lisa McDonald, Vice President of Communications, 202-207-2829
Washington, DC – The National Consumers League (NCL) submitted comments to the U.S. Food and Drug Administration (FDA) urging the agency to reject a citizen petition from Children’s Health Defense (CHD) seeking to remove over-the-counter acetaminophen products for children under two and require boxed warnings linking acetaminophen to autism spectrum disorder (ASD).
“Parents need safe and effective options when their child is sick or in pain, and deserve reliable information they can trust,” said Lisa Bercu, NCL Senior Director of Health Policy. “Leading pediatric experts have been clear that the evidence does not establish that acetaminophen causes autism. Removing products from the market or imposing a boxed warning could unnecessarily alarm families, discourage appropriate treatment, and leave parents with fewer options when their children are sick or in pain.”
The American Academy of Pediatrics (AAP) has stated plainly that decades of research support the safety of acetaminophen for children when administered as directed and that studies do not establish a causal link between acetaminophen use in children and Autism.
“Imposing a serious FDA warning, contrary to leading pediatric expert opinion and without sufficient evidence, could also undermine public confidence in the scientific integrity of FDA’s labeling decisions,” Bercu concluded. “For more than 70 years families have relied on acetaminophen to treat children’s pain and fever, and leading pediatric experts continue to recognize it as safe and effective when used as directed.”
NCL’s comments are available here.
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About the National Consumers League (NCL)
The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.
