July 23, 2009 - In late June an advisory panel urged the Food and Drug Administration to lower the maximum over-the-counter dosage for acetaminophen. The recommendation came on the heels of an FDA report that found acetaminophen can cause severe liver damage when used in excess of recommended dosages.

Acetaminophen is one of the most commonly used over-the-counter or OTC drugs, and is often a component in multisymptom OTC medicines. FDA’s concern stems from overuse by unassuming patients, who may take a cold remedy and an acetaminophen-based pain reliever at the same time, intending to vanquish their symptoms as fast as possible, but not realizing that they’ve unintentionally taken a double dose of acetaminophen, and may be harming their livers.

The panel's advice highlights a problem the Institute of Medicine addressed in the report Preventing Medication Errors: Quality Chasm Series. The report focused on assessing and improving the quality of the nation’s health care and suggests that the most powerful strategy for improving the safety of medication use is encouraging a strong patient-provider relationship that fully engages the patient’s attention when it comes to medication. The report recommends specific steps that physicians, nurses, pharmacists, and other health professionals should take to ensure that their patients are fully informed about their drug regimens and to minimize opportunities for mistakes -- such as acetaminophen overdose -- to occur.

• FDA Acetaminophen Information