Early 2011, the FDA determined that specific mix pain drugs like Vicodin (hydrocodone/acetaminophen), and Percocet (oxycodone/acetaminophen) shouldn’t include more than 325mg of acetaminophen per capsule or tablet. That is in an attempt to minimize the danger of liver damage. “Overdose from prescription mix products containing acetaminophen bill for almost half of cases of acetaminophen-related liver failure within the United States; a lot of which lead to liver transplant or death,” mentioned Sandra Kweder, doctor, deputy manager of Work of New Drugs in Food and Drug Administration’s Center for Drug Analysis and Study (CDER).
By January 14, 2014, all prescription pain combination products that include greater than 325mg of acetaminophen must be discontinued by manufacturing companies. What this means is that your current prescription of pain medicine that comprises greater than 325mg of acetaminophen might not be filled next date. There might be delays in getting your prescription. You will have to call your physician for a new prescription using the modifications. Permit time for the drugstore to get the new formulations and to fill your prescription. Reformulated Vicodin ES, Vicodin and Vicodin HP have 300mg of tylenol per pill. Norco (hydrocodone/acetaminophen) may still include 325mg of acetaminophen.
Special labeling is also required by the FDA. A black box warning saying risk and the risks of liver injury will be put into all prescription medication labels that include acetaminophen.
Confusion may be caused by the changes to your pain medications but is essential to reduce the cases of liver damage because of acetaminophen poisoning.
USA Food and Drug Administration (FDA). FDA limits acetaminophen in prescription combination products; requires liver toxicity warnings. January 13, 2011
USA Food and Drug Administration (FDA). Questions and answers about oral prescription acetaminophen products to be limited to 325mg per dosage unit. Accessed: Dec 17, 2013. http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm239871.htm