The U.S. Food and Drug Administration (FDA) recently announced a formal review of regulations governing ingredients found in over-the-counter (OTC) drugs, including the acetaminophen used in the popular OTC pain reliever Tylenol.
“The FDA’s recent review of over-the-counter medications is a positive step forward for consumer safety, as the dangers of acetaminophen and other OTC drug overdoses are real,” commented Megan McBride, a lawyer with the Levin, Papantonio law firm who practices in the areas of personal injury, product liability, and bad-drug litigation.
Acetaminophen, which is found in many popular OTC drugs, has been linked to the development of serious and life-threatening health conditions, including acute liver failure; two deadly skin reactions: Steven-Johnson Syndrome (SJS) and toxic epidermal necrolysis; and birth defects.
According to ProPublica, the FDA blames its decades-old monograph approval process, intended to hasten the evaluation process, for allowing several ingredients found in OTC medications to be used without being fully approved. Of 1,700 active ingredients found in OTC medications, only 60% have received final approval from the FDA. The remaining 40 percent, which includes acetaminophen, have been used in OTC medicines without a final thumbs up of approval.
According to an ongoing ProPublica investigation, the FDA went back-and-forth with Tylenol’s manufacturer, Johnson & Johnson subsidiary McNeil Consumer Healthcare, from the years 1995 until 2011 over concerns of the safety of two childrens’ Tylenol products, Infants’ Tylenol and Childrens’ Tylenol, and how to make improvements. Over that 15 year span, some 20 children died from acetaminophen overdose after their parents accidentally administered too much of the medicine, making it clear that the FDA had failed to intervene.
In contrast, however, the monograph process has allowed the agency to make quick changes to product warning labels and dosage amounts in the past, the most recent change being that all medications containing acetaminophen contain no more than 325 milligrams (mg) of the ingredient per dose. However, the recent regulation applied to only prescription drugs, and consumers can still buy OTC medications, such as OTC Tylenol Arthritis Pain Reliever, containing nearly twice the 325 mg limit of acetaminophen.