FDA Rules For New Warnings And Reduced Dosage Of Acetaminophen

In an era where prescription drugs are abused as much or more than illegal ones, too little warning is placed on medications that can cause serious implications if misused. Last week the FDA handed down a new warning to be placed on any prescription drug that contains the popular pain reliever acetaminophen, also known as the brand name Tylenol. Currently, some acetaminophen pills contain as much as 500mg to 750mg per dose. Tylenol will be required to limit the amount to 325mg because of the potential for serious liver damage if overdoses occur. This new warning by the FDA will be the strongest warning for a prescription drug yet.

Over-the-counter variations will not be affected by this decision, although changes are being considered. When acetaminophen is used in a prescription pain reliever, it is usually combined with higher strength opioids like oxycodone and hydrocodone to make powerful combination drugs like Percocet and Vicodin. The problem therein is that patients who have been prescribed these medications dont often know that theyre also taking large quantities of acetaminophen. The FDAs new Center for drug Evaluation and research is looking more closely at damages caused by drugs like these. The Office of New Drugs deputy director, Dr. Sandra Kweder had this to say, Overdose from prescription combination products containing acetaminophen account for nearly half of all cases of acetaminophen related liver failure in the United States, many of which result in liver transplant or death."

Close to 200 million prescriptions were written for acetaminophen/opioid drugs in 2008, which prompted the FDA to recommend stronger warnings on their labels in 2009. Now, that recommendation has finally become a reality. Until further action is taken regarding the over-the-counter varieties, its important to remember that prolonged use and overdose is still possible. Many people avoid the directed dosage amounts in order to get rid of a stubborn headache or other pain. The switch to lower dosage will take about three years to implement, and prescriptions will still be available over that time.

Sources:
FDA Acetaminophen Information

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