Medication Alert- Acetaminophen Toxicity and important changes to Created by on 7/24/2012 11:18:43 AM
Acetaminophen toxicity continues to be an ongoing problem for US consumers.
Medication Alert- Acetaminophen Toxicity and important changes to Vicodin
by Christine Dreher Consultant RPh
Acetaminophen toxicity continues to be an ongoing problem for US consumers. Overdoses from prescription products containing Acetaminophen account for nearly half of all cases of acetaminophen related liver failure in the US, many of which result in liver transplant or death. Most cases of severe liver injury in association with Acetaminophen occurred in patients, who took more than the recommended amount in a 24 hour period, or they took more than one product containing Acetaminophen at the same time, or they consumed alcohol. With this being said, the FDA has instructed drug manufacturers to limit the strength of acetaminophen in prescription drug products, including acetaminophen and opioid combination products to no more than 325mg per dose. The FDA hopes that this will limit the risk of severe liver injury and are requesting this change be in effect by January 2014.
Abbott Pharmaceuticals, manufacturer of Vicodin, Vicodin ES, and Vicodin HP, has decided to comply with this request ahead of schedule. The new formulations of Vicodin that will contain 300mg of acetaminophen will not be available until sometime during the third quarter of 2012. At this time Abbott is no longer manufacturing the current formulations of Vicodin. Because of the above situation OrionRx is asking facilities for their help. We are attempting to notify physicians that there may be a shortage in Vicodin until the new formulation is available. To avoid residents’ therapy from being interrupted we are asking that once a resident’s current supply of Vicodin is exhausted that we switch the medication order to a Norco formulation that contains 325mg of acetaminophen. Hopefully changing these orders now can avoid any interruptions in therapy. Your consultant pharmacists are aware and writing recommendations but your help notifying physicians of this situation would be beneficial. We at OrionRx want to help you, our customer, keep our residents safe.
References: 1. United States Department of Health and Human Services. FDA drug safety Communication. Food and Drug Administration Web Site. http://www.fda.gov/Drugs/DrugSafety/Information. Accessed 7/1/12 2. Abbott Laboratories Web site http://www.vicodin.com/hcp/?cid=ppc_ppd_vcdn_ggl_ppc_0186