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藥物警訊

 

Over-the-Counter Antacid Products Containing Aspirin: FDA Drug Safety Communication - Serious Bleeding Risk

 

AUDIENCE: Consumer


ISSUE: The FDA is warning consumers about the risk of serious bleeding when using nonprescription, also known as over-the-counter or OTC, aspirin-containing antacid products to treat heartburn, sour stomach, acid indigestion, or upset stomach. Many other products for these conditions are available that do not contain aspirin.


These widely used products already contain warnings about this bleeding risk on their labels; however, we are continuing to receive reports of this serious safety issue. As a result, we will continue to evaluate this safety concern and plan to convene an advisory committee of external experts to provide input regarding whether additional FDA actions are needed.


BACKGROUND: OTC aspirin-antacid products are sold under various trade names, including Alka-Seltzer Original, Bromo Seltzer, MediqueMedi Seltzer, Picot Plus Effervescent, Vida Mia Pain Relief, Winco Foods Effervescent Antacid and Pain Relief, and Zee-Seltzer Antacid and Pain Reliever. They are also available as generic products.


In 2009, a warning about the risk of serious bleeding was added to the labels of all OTC products that contain NSAIDs, including aspirin-containing antacid products. However, a search of the FDA Adverse Event Reporting System (FAERS) database identified eight cases of serious bleeding events associated with these products after the warning was added. All of these patients were hospitalized. Patients had underlying conditions such as the risk factors above that put them at greater risk for developing serious bleeding events (see Data Summary). The FAERS database includes only reports submitted to FDA so there are likely additional cases about which we are unaware.


RECOMMENDATION: Consumers should always read the Drug Facts label carefully when purchasing or taking an OTC product to treat heartburn, acid indigestion, or sour or upset stomach. If the product contains aspirin, consider whether you should choose a product without aspirin to relieve your symptoms.


Aspirin is a commonly used pain reducer and fever reducer. It is a nonsteroidal anti-inflammatory drug (NSAID) that can increase the risk of bleeding, including in the stomach and gastrointestinal (GI) tract. Ask your pharmacist if you need help reading the Drug Facts label.


If you have one or more of the following risk factors, you may have a higher chance of serious bleeding when taking aspirin-containing antacid products:


‧ Are 60 years or older
‧ Have a history of stomach ulcers or bleeding problems
‧ Take a blood-thinning or steroid medicine
‧ Take other medicines containing NSAIDs such as ibuprofen or naproxen
‧ Drink three or more alcoholic drinks every day


Taking more of these medicines than the amount recommended or for a longer period than recommended will increase the risk of serious bleeding.


Read the MedWatch safety alert, including a link to the Drug Safety Communication, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm505190.htm


美國FDA發布藥品安全警訊,提醒民眾使用含aspirin成分制酸劑之非處方藥治療胃灼熱、胃酸過多或胃痛可能出現嚴重出血風險。建議應改用其他不含aspirin成分之藥品。


自2009年起,所有含非類固醇消炎止痛藥(包括含aspirin成分之制酸劑)之仿單中已加註有關嚴重出血風險之警語,但仍持續接獲相關副作用通報案例。美國FDA將持續評估此安全性問題,並計劃召集專家組成相關委員會討論是否需進一步處置。


Aspirin常用於止痛及退燒,屬非類固醇消炎止痛藥,副作用可能增加胃腸道出血風險。病人應於購買前向藥師諮詢是否適合使用此類藥品。


病人若符合以下1項以上條件,服用含aspirin成分制酸劑可能具有較高的出血風險:


1. 年齡大於60歲以上。
2. 曾有胃潰瘍或出血之病史。
3. 正在服用抗凝血劑或類固醇成份藥品。
4. 正服用其他含非類固醇消炎止痛藥,如ibuprofen或naproxen。
5. 每日飲用三杯以上含酒精飲料。


美國FDA提醒大眾服用超過建議劑量或建議服用期間可能增加嚴重出血之風險。在購買或服用治療胃灼熱、胃酸過多或胃部不適之非處方藥前,應詳細閱讀藥品說明書。若藥品含有aspirin,應考慮自我身體狀況是否適用,或選擇其他不含aspirin成分之藥品。


相關訊息與連結請參考FDA網址:


http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm505190.htm
[Posted 06/06/2016]


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

 

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