藥物警訊

Acetaminophen Prescription Combination Drug Products with more than 325 mg: FDA Statement - Recommendation to Discontinue Prescribing and Dispensing

AUDIENCE: Consumer, Dentistry, Emergency Medicine, Internal Medicine, Pharmacy, Pain Management, Surgery

ISSUE: FDA is recommending health care professionals discontinue prescribing and dispensing prescription combination drug products that contain more than 325 milligrams (mg) of acetaminophen per tablet, capsule or other dosage unit. There are no available data to show that taking more than 325 mg of acetaminophen per dosage unit provides additional benefit that outweighs the added risks for liver injury. Further, limiting the amount of acetaminophen per dosage unit will reduce the risk of severe liver injury from inadvertent acetaminophen overdose, which can lead to liver failure, liver transplant, and death.

Cases of severe liver injury with acetaminophen have occurred in patients who:

‧ took more than the prescribed dose of an acetaminophen-containing product in a 24-hour period; 

‧ took more than one acetaminophen-containing product at the same time; or 

‧ drank alcohol while taking acetaminophen products.

BACKGROUND: In January 2011 FDA asked manufacturers of prescription combination drug products containing acetaminophen to limit the amount of acetaminophen to no more than 325 mg in each tablet or capsule by January 14, 2014. FDA requested this action to protect consumers from the risk of severe liver damage which can result from taking too much acetaminophen. This category of prescription drugs combines acetaminophen with another ingredient intended to treat pain (most often an opioid), and these products are commonly prescribed to consumers for pain, such as pain from acute injuries, post-operative pain, or pain following dental procedures.

Acetaminophen is also widely used as an over-the-counter (OTC) pain and fever medication, and is often combined with other ingredients, such as cough and cold ingredients. FDA will address OTC acetaminophen products in another regulatory action. Many consumers are often unaware that many products (both prescription and OTC) contain acetaminophen, making it easy to accidentally take too much.

More than half of manufacturers have voluntarily complied with the FDA request. However, some prescription combination drug products containing more than 325 mg of acetaminophen per dosage unit remain available. In the near future FDA intends to institute proceedings to withdraw approval of prescription combination drug products containing more than 325 mg of acetaminophen per dosage unit that remain on the market.

RECOMMENDATION: FDA recommends that health care providers consider prescribing combination drug products that contain 325 mg or less of acetaminophen. FDA also recommends that when a pharmacist receives a prescription for a combination product with more than 325 mg of acetaminophen per dosage unit that they contact the prescriber to discuss a product with a lower dose of acetaminophen. A two tablet or two capsule dose may still be prescribed, if appropriate. In that case, the total dose of acetaminophen would be 650 mg (the amount in two 325 mg dosage units). When making individual dosing determinations, health care providers should always consider the amounts of both the acetaminophen and the opioid components in the prescription combination drug product.

Read the MedWatch Safety Alert, including links to the FDA Statement at:http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm381650.htm

美國FDA發佈安全警訊，因目前尚未有資料顯示服用單位劑量大於325 mg的乙醯胺酚(acetaminophen)利大於弊，故不建議醫療人員處方及調劑每單位含有超過325 mg acetaminophen之複方製劑。此外，限制藥品每單位的acetaminophen含量，可降低因過量服用而導致之肝臟損害甚至死亡的風險。

FDA整理曾發生acetaminophen相關的嚴重肝臟損害案例如下：

‧ 24小時內服用超過處方劑量的acetaminophen。

‧ 同時服用兩種以上含acetaminophen成分之藥品。

‧ 服用acetaminophen且同時飲酒。

背景

為了保障消費者的用藥安全，以免因服用過量acetaminophen而產生嚴重肝臟傷害的風險，FDA在2011年1月起要求含有acetaminophen成分的複方製劑其acetaminophen含量不得超過325 mg，且限於2014年1月14日完成變更。此類藥品主要為疼痛控制，且常使用於治療如急性受傷、術後疼痛或牙科手術後止痛。

Acetaminophen為常見的止痛及退燒藥物，且常與其他藥品作成複方製劑，如止咳或感冒藥。消費者通常不了解許多產品中含有acetaminophen，因此很容易不小心服用過量。目前市面上仍有一些含有超過325 mg的acetaminophen複方製劑，將來FDA擬撤回這些複方藥之上市許可。

建議

FDA建議醫療人員應考慮處方325 mg以下之acetaminophen複方製劑。藥師若發現醫師開方每單位含量超過325 mg acetaminophen之複方藥時，應與醫師討論調低劑量。若臨床診斷有治療需求，單次劑量最多可處方650 mg。FDA再次呼籲醫療人員應謹慎評估病人的acetaminophen及鴉片類成分藥品劑量。

相關訊息與連結請參考FDA網址：http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm381650.htm

資料來源：美國FDA之藥物安全警訊

資料提供：台大醫院藥劑部