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FDA Limits Acetaminophen in Vicodin and Percocet

Written by Ankin Law Office

Vicodin and Percocet – two popular painkillers – could soon be a thing of the past.  Last year, the U.S. Food and Drug Administration (FDA) limited the amount of the key ingredient acetaminophen found in Vicodin, Percocet and other prescription painkillers at 325 milligrams per capsule due to concerns that the ingredient was linked to thousands of cases of liver damage each year.  Prior to the FDA’s imposed limitation, products on the market contained doses of up to 700 milligrams.

According to this article, acetaminophen is the leading cause of liver failure in the U.S., sending 56,000 people to the emergency room each year and accounting for about 120 deaths annually.

The restrictions do not impact over-the-counter products such as Tylenol and Theraflu, but the FDA continues to consider placing limitations on those products as well.  Changes impacting over-the-counter drugs require a more complicated rule-making process, however, than those for prescription drugs.  For the time being, over-the-counter products will actually be permitted to contain higher doses of the drug – up to 500 milligrams per pill or capsule – despite the fact that, in 2009, a 37 member panel of the FDA recommended a reduction in the maximum dose of Tylenol and the elimination of prescription drugs Vicodin and Percocet.

What Is Acetaminophen?

Acetaminophen is a common pain reliever ingredient found in Tylenol, Nyquil and other prescription and over-the-counter medications used to treat chronic pain, headaches, fever and sore throats.  Although acetaminophen-containing products used alone are not necessarily dangerous, toxic overdoses can occur when patients combine them with a second acetaminophen-containing drug.

Since the labels of prescription drugs often do not clearly indicate that the drug contains acetaminophen by using abbreviations such as “APAP,” the FDA has indicated that it is working with pharmacies and other medical groups to develop standard labeling mechanisms for drugs containing acetaminophen.

Vicodin, which is marketed by Abbott Laboratories, combines acetaminophen with hydrocodone.  Percocet, which is marketed by Endo Pharmaceuticals, contains oxycodone. Both Vicodin and Percocet are available in cheaper generic versions.

On a related note, the FDA’s Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee voted last year to require that children’s oral single-ingredient acetaminophen products carry dosing instructions for babies between the ages of 6 months and 2 years.

Drug manufacturers are under an obligation to ensure that the drugs that they develop are safe and that they contain adequate warning labels.  If a consumer is injured as a result of taking an unsafe pharmaceutical drug, he or she may be entitled to compensation for injuries suffered in a personal injury or product liability lawsuit.  If a large number of consumers have been injured by the unsafe drug, a class action lawsuit may be appropriate.  At Ankin Law Offices, LLC, our Chicago unsafe pharmaceutical drug attorneys have considerable experience representing clients in a wide variety of personal injury and product liability lawsuits, including class action lawsuits based on unsafe pharmaceutical drugs.

Categories: Personal Injury