FDA reminds health care professionals to stop dispensing prescription combina...

FDA reminds health care professionals to stop dispensing prescription combination drug products with more than 325 mg of acetaminophen

FDA is reminding health care professionals to stop prescribing and pharmacists to stop dispensing prescription combination drug products that contain more than 325 milligrams (mg) of acetaminophen per tablet, capsule, or other dosage unit. If a pharmacist receives a prescription for a combination product with more than 325 mg of acetaminophen per dosage unit, FDA recommends that they contact the prescriber to discuss a product with a lower dose of acetaminophen. These products are no longer considered safe by FDA and have been voluntarily withdrawn. We encourage pharmacists to return them to the wholesaler or manufacturer.

These products were voluntarily withdrawn by the manufacturers at FDA’s request to protect consumers from the risk of severe liver damage, which can result from taking too much acetaminophen.

FDA also asks wholesalers to remove the product codes for all prescription combination drug products containing more than 325 mg of acetaminophen per dosage unit from their ordering systems and return all products to the manufacturers.

Health care professionals who have questions are encouraged to contact the Division of Drug Information at 888.INFO.FDA (888-463-6332) or druginfo@fda.hhs.gov

国家局曾在药物警戒快讯 2014年第2期 （总第130期）关于

　 “  FDA限制含对乙酰氨基酚处方药的单位剂量不超过325毫克
　　FDA限制处方药中对乙酰氨基酚剂量不超过325毫克；增加黑框警告强调对乙酰氨基酚处方药可能会导致严重肝功能衰竭
　　FDA关于口服处方药中对乙酰氨基酚单位剂量限制在325毫克问答
　　FDA建议停止处方和销售处方药中对乙酰氨基酚含量超过325mg的复方制剂”

进行说明。4月28日，FDA明确提出停止处方和销售处方药中对乙酰氨基酚含量超过325mg的复方制剂。

之前都是限制，现在是停止。