FDA Opens Review of Rules for Over-the-Counter Drugs, Including Acetaminophen - ProPublica
The U.S. Food and Drug Administration has launched a review of the way it ensures the safety and use of over-the-counter drugs taken by hundreds of millions of Americans, opening the door to the most significant reform in four decades.
The agency’s announcement follows a ProPublica investigation last fall focusing on acetaminophen, the active ingredient in Tylenol, which is among the drugs that would fall within the review.
As we reported, despite more than 40 years of work, the FDA has yet to finalize rules governing the safe use of acetaminophen, hobbled, in part, by the cumbersome and bureaucratic system for regulating non-prescription drugs.
Acetaminophen can cause liver damage and death in amounts close to the current recommended daily limit. Our investigation found that about 150 people die each year from accidentally taking too much of the drug. Tens of thousands of others are rushed to the emergency room or hospitalized.