Acetaminophen Limited by FDA to Prevent Liver Damage

For some time now, it has been known, or at least suspected, that high doses of pain-relieving agent acetaminophen can lead to serious liver damage. Acetaminophen is sold over the counter on its own (Tylenol), or as an ingredient in more powerful pain medications, such as Percocet (oxycodone and acetaminophen) and Vicodin (hydrocodone and acetaminophen). Back in 2011, the Food and Drug Administration (FDA) issued a release, taking steps to reduce the risk of liver damage from acetaminophen.

Essentially, the FDA called for two things of medicines containing acetaminophen. First, there must be a clear warning on the box, detailing the potential risk for “severe liver injury.” Second, prescription medications should be limited to a maximum of 325 milligrams of acetaminophen per tablet, pill or capsule.

Recently, the FDA issued a statement that all manufacturers of medications containing more than 325 milligrams of acetaminophen per dosage unit have stopped marketing such products. Additionally, the FDA also issued a statement reminding health care providers not to prescribe such products, and pharmacists to stop dispensing them. In short, the position of the FDA is that “(t)hese products are no longer considered safe by FDA and have been voluntarily withdrawn.”

Injured workers, and others with chronic pain, can safely continue to use medications containing acetaminophen, according to the FDA, within these guidelines. As with any medication, it is important for users to follow the dosage recommendations of their physicians, or their pharmacists, to assure that these (and other) medications remain safe, and risks or harmful side effects are lessened.