Comment Submissions - Announcement of Additional Public Comment Period on Acetaminophen

Acetaminophen controls pain and fever but does not reduce inflammation, as does aspirin and the other widely consumed nonsteroidal anti-inflammatory drugs (NSAIDs) ibuprofen (Advil, Motrin, generics) and naproxen (Aleve, generics). But unlike NSAIDs, acetaminophen does not irritate the stomach and intestinal lining. That means a person who cannot tolerate NSAIDs can still take acetaminophen. It's an important drug for controlling chronic pain in older adults. Acetaminophen has a narrow window of safety compared with ibuprofen and naproxen. NSAIDs can make you sick, too, but it takes a larger amount to reach a dangerous overdose. Taking too much acetaminophen can damage the liver, sometimes leading to a liver transplant or death. The FDA has recognized this risk and the Drug Facts labeling for the approximately 600 acetaminophen OTC products in the US includes warnings related to liver health risks. Were CA to add acetaminophen to the Prop 65 list for cancer this could lead to consumer confusion regarding the safety of acetaminophen as it relates to cancer risk. This could lead consumer to use other forms of pain relievers such as NSAIDs or opiod based pain relief medication that have other risk profiles related to cardiovascular health and bleeding risk in the GI tract as noted earlier. Opioids are highly addictive and this presents a different risk issue. There is no concrete data to link acetaminophen to cancer risk. The US FDA has an abundance of data available from their Adverse Event Reporting System and there is no evidence that acetaminophen has a link to cancer. PL Developments sides with the Consumer Healthcare Products Association's view that acetaminophen does not pose a carcinogenicity hazard to human health as they demonstrated in their detailed DILIsym(TM) analysis of toxicity related to acetaminophen use. Adding the Prop 65 warning to OTC products that contain acetaminophen could lead to unintended health consequences as this could deter consumers from using the safest choice they have for pain relief.