FDA Drug Safety Communication: Prescription Acetaminophen Products to be Limited to 325 mg Per Dosage Unit; Boxed Warning Will Highlight Potential for Severe Liver Failure
FDA限定处方药对乙酰氨基酚单剂量325mg以内，且增加肝功能衰竭警告
[1-13-2011] The U.S. Food and Drug Administration (FDA) is asking drug manufacturers to limit the strength of acetaminophen in prescription drug products, which are predominantly combinations of acetaminophen and opioids. This action will limit the amount of acetaminophen in these products to 325 mg per tablet, capsule, or other dosage unit, making these products safer for patients.
In addition, a Boxed Warning highlighting the potential for severe liver injury and a Warning highlighting the potential for allergic reactions (e.g., swelling of the face, mouth, and throat, difficulty breathing, itching, or rash) are being added to the label of all prescription drug products that contain acetaminophen.
详情请看
http://www.fda.gov/Drugs/DrugSafety/ucm239821.htm
作为OTC的泰诺的规格：
对乙酰氨基酚：325mg；
说明书中：“一次1-2片，每六小时服用一次，24小时不得超过四次”
多大的销量啊。笔者周围，照着这个吃药的人大有人在，一天吃八片。而且还是老人（医院太麻烦自己去药店买来）。
SFDA敢取消泰诺的OTC吗？
泰诺与曲美不同啊，“强生”占据市场。
康泰克每片含对乙酰氨基酚500毫克呢！
FDA限定处方药对乙酰氨基酚单剂量325mg以内，且增加肝功能衰竭警告
[1-13-2011] The U.S. Food and Drug Administration (FDA) is asking drug manufacturers to limit the strength of acetaminophen in prescription drug products, which are predominantly combinations of acetaminophen and opioids. This action will limit the amount of acetaminophen in these products to 325 mg per tablet, capsule, or other dosage unit, making these products safer for patients.
In addition, a Boxed Warning highlighting the potential for severe liver injury and a Warning highlighting the potential for allergic reactions (e.g., swelling of the face, mouth, and throat, difficulty breathing, itching, or rash) are being added to the label of all prescription drug products that contain acetaminophen.
详情请看
http://www.fda.gov/Drugs/DrugSafety/ucm239821.htm
作为OTC的泰诺的规格：
对乙酰氨基酚：325mg；
说明书中：“一次1-2片，每六小时服用一次，24小时不得超过四次”
多大的销量啊。笔者周围，照着这个吃药的人大有人在，一天吃八片。而且还是老人（医院太麻烦自己去药店买来）。
SFDA敢取消泰诺的OTC吗？
泰诺与曲美不同啊，“强生”占据市场。
康泰克每片含对乙酰氨基酚500毫克呢！