FDA to Weigh Recommendations on Acetaminophen Containing Medicines Such as Tylenol

July 2, 2009 – The Food and Drug Administration (FDA) held a public advisory committee meeting on June 29 and June 30, 2009 to discuss acetaminophen use in both over-the-counter (OTC) and prescription (Rx) products, the potential for liver injury, and potential interventions to reduce the incidence of liver injury. Acetaminophen containing products are used extensively making the absolute number of liver injury cases a public health concern, according to the FDA.

The Drug Safety and Risk Management Advisory Committee with the Anesthetic and Life Support Drugs Advisory Committee and the Nonprescription Drugs Advisory Committee provided the FDA with independent advice from outside experts. These recommendations are advisory in nature and the FDA is not bound to follow their recommendations. At this time, the FDA has not made any decisions regarding acetaminophen containing products, but is reviewing the recommendations of the advisory committee, all available safety and efficacy data as well as public input before making a final decision.

News From Our Lawyers: FDA Panel Gives Acetaminophen Recommendations

FDA Panel Recommends Lowering Dose of OTC Tylenol Due to Liver Damage Risk

fdaThe Food and Drug Administration (FDA) convened a public advisory committee meeting on June 29 and June 30, 2009 regarding acetaminophen use in both over-the-counter (OTC) and prescription (Rx) products, the potential for liver injury, and potential interventions to reduce the incidence of liver injury.

Acetaminophen is the generic name of a drug found in many common brand name OTC products such as Tylenol, as well as prescription products such as Vicodin and Percocet. click here

Tylenol, a 50-year-old staple of households across America, and Vicodin, the most prescribed drug in the U.S., may face new restrictions because of the risk of liver damage tied to the ingredient acetaminophen.

A panel of advisers to the Food and Drug Administration voted yesterday in favor of banning prescription drugs Vicodin, Percocet and other medicines that combine acetaminophen with a narcotic. The panel also urged that Tylenol be given in lower doses than now recommended and the extra- strength version be sold by prescription only.

“The reality is we’ve known for some time that Tylenol plus alcohol is potentially damaging to livers, and we’ve also known that way too much is damaging to livers,” pharmaceutical analyst Les Funtleyder of Miller Tabak & Co. told Bloomberg News. “It’s not a huge surprise.”

According to the Food and Drug Administration, a study that combined data from 22 specialty medical centers in the United States found that acetaminophen-related liver injury from Tylenol and other medicines, was the leading cause of acute liver failure for the years 1998 through 2003.