FDA limits acetaminophen in prescription combination products; requires liver toxicity warnings
FDA is asking manufacturers of prescription combination products that contain acetaminophen to limit the amount of acetaminophen to no more than 325 mg in each tablet or capsule.
FDA is asking manufacturers of prescription combination products that contain acetaminophen to limit the amount of acetaminophen to no more than 325 mg in each tablet or capsule.
FDA also is requiring manufacturers to update labels of all prescription combination acetaminophen products to warn of the potential risk for severe liver injury.
Acetaminophen is combined in many prescription products with other ingredients, usually opioids such as codeine (Tylenol with Codeine), oxycodone (Percocet), and hydrocodone (Vicodin).
“It has been well documented for some time now that acetaminophen, while a widely popular and highly effective analgesic and antipyretic agent, does pose a significant risk of fulminant hepatic failure when overdosed,” said Formulary Clinical Editor David Calabrese, RPh, MHP.
“This action by FDA should be welcomed by our healthcare community as a positive step toward promoting improved quality of pharmaceutical care by limiting the potential for inadvertent acetaminophen liver toxicity and death,” said Calabrese, chief clinical officer, Med Metrics Health Partners, Worcester, Mass. “Our pharmacy and managed care professions should embrace these changes and do our part to help better educate the provider and patient community relative to these impending changes.”
The current maximum dose of acetaminophen is 4000 mg per 24-hour period.
David Calabrese of OptumRx Talks Top Three Drugs in Pipeline, Industry Trends in Q2
July 1st 2020In this week's episode of Tuning Into The C-Suite podcast, MHE's Briana Contreras chatted with David Calabrese, R.Ph, MHP, who is senior vice president and chief pharmacy officer of pharmacy care services company, OptumRx. David is also a member of Managed Healthcare Executives’ Editorial Advisory Board. During the discussion, he shared the OptumRx Quarter 2 Drug Pipeline Insights Report of 2020. Some of the information shared includes the three notable drugs currently being reviewed or those that have been recently approved by the FDA. Also discussed were any interesting industry trends to watch for.
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