Other safety alerts
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| The United States: FDA limits acetaminophen in prescription combination products; requires liver toxicity warnings |
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The U.S. Food and Drug Administration is asking manufacturers of prescription combination products that contain acetaminophen to limit the amount of acetaminophen to no more than 325 milligrams (mg) in each tablet or capsule. The 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, also called APAP, is a drug that relieves pain and fever and can be found in both prescription and over-the-counter (OTC) products. It is combined in many prescription products with other ingredients, usually opioids such as codeine (Tylenol with Codeine), oxycodone (Percocet), and hydrocodone (Vicodin). OTC acetaminophen products are not affected by today's action. Drug companies will have three years from the date of publication of the Federal Register Notice (January 14, 2011) to limit the amount of acetaminophen in their prescription drug products to 325 mg per dosage unit.
Please refer to the following website in FDA for details:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm239894.htm
In Hong Kong, there are ten products registered which contains paracetamol (another name of acetaminophen) in combination with opioids. Most of these products are prescription drugs. In light of the new labeling requirement of FDA, the issue will be considered in the coming meeting of the Registration Committee of Pharmacy and Poisons Board. Letter to inform healthcare professionals about FDA’s decision and remind them about using acetaminophen safely will be issued. In addition, any actions from other health authorities will be kept in view.
Ends/Friday, January 14, 2011
Issued at HKT 14:30
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