Beginning this fall, the maximum dose of Extra Strength Tylenol, a brand of acetaminophen that contains 500 milligrams of the drug per pill, will be reduced from eight pills per day to six pills per day, or from 4,000 milligrams to 3,000 milligrams. Johnson & Johnson’s McNeil Consumer Healthcare announced the change in July. The company will also reduce the maximum dosage of Regular Strength Tylenol and other acetaminophen products in 2012. In a similar move, the U.S. Food and Drug Administration (FDA) ordered earlier this year that acetaminophen in prescription painkillers, such as Vicodin and Percocet, will be capped at 325 milligrams per capsule instead of the 700 milligrams previously allowed. The recent dosage adjustments are intended to reduce the number of acetaminophen overdoses, which can be fatal or cause serious health problems. Patients harmed by this dangerous drug can learn about their legal rights by contacting an experienced drug attorney.
Reportedly, each year in the United States, approximately 200 people die and 56,000 people seek emergency room treatment for acetaminophen overdoses. The FDA estimates that 120 of those 200 deaths are linked to prescription drugs containing acetaminophen. Because acetaminophen is available as an over-the-counter pain reliever by itself, in addition to being used in numerous combination medications available over-the-counter, such as NyQuil, Theraflu and Excedrin, and several prescription painkillers, many patients do not realize when they are taking multiple medications with acetaminophen or how much acetaminophen is contained in each product. When that happens, a patient may inadvertently exceed the maximum daily dosage of acetaminophen, which can lead to complications including liver failure. Acetaminophen remains one of the most commonly used drugs in the United States, with U.S. consumers purchasing 28 billion doses of acetaminophen-containing medications in 2005. When research emerged in the late 1990s citing acetaminophen as a major cause of acute liver failure, the FDA began taking steps to address the issue.
An FDA panel recommended in 2009 that the maximum dosage of acetaminophen be reduced in over-the-counter medications, a recommendation to which Johnson & Johnson’s recent dosage reduction directly responds. The FDA panel expressed concern over acetaminophen remaining the leading cause of liver failure despite years of educational campaigns and federal actions that have attempted to address the issue. Only time will tell if the recent dosage reductions impact the number of acetaminophen overdoses.
Patients injured by an acetaminophen overdose or any other defective drug should discuss their case with a qualified drug lawyer. Each year in the United States, hundreds of drug recalls are issued, and patients harmed by a dangerous or recalled drug may be entitled to compensation.