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PARSIPPANY, N.J. — Actavis is launching new formulations of a drug used to treat tension headaches, the company said Monday.
The drug maker announced new formulations for Fioricet (butalbital; acetaminophen; caffeine) capsules and Fioricet with Codeine that reduce the amount of acetaminophen from 325 mg to 300 mg. Actavis said the formulation would provide a safer treatment option for patients.
The reformulation follows Food and Drug Administration guidelines recommending that manufacturers limit the amount of acetaminophen in all prescription drug products. While instances are rare when considering how commonly it's used, acetaminophen is known to cause acute liver failure if patients overdose on it, and the drug was a leading cause of acute liver failure between 1998 and 2003, according to the National Council for Prescription Drug Programs and a 2005 study. Each year, there are about 458 deaths, 26,000 hospitalizations and 56,000 emergency room visits related to overdoses of the drug, according to another study.