藥物警訊

Acetaminophen: Drug Safety Communication - Association with Risk of Serious Skin Reactions
 

AUDIENCE: Dermatology, Primary Care, Pharmacy
 

ISSUE: FDA notified healthcare professionals and patients that acetaminophen has been associated with a risk of rare but serious skin reactions. Acetaminophen is a common active ingredient to treat pain and reduce fever; it is included in many prescription and over-the-counter (OTC) products. These skin reactions, known as Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP), can be fatal. These reactions can occur with first-time use of acetaminophen or at any time while it is being taken. Other drugs used to treat fever and pain/body aches (e.g., non-steroidal anti-inflammatory drugs, or NSAIDS, such as ibuprofen and naproxen) also carry the risk of causing serious skin reactions, which is already described in the warnings section of their drug labels.

BACKGROUND: This new information resulted from the Agency’s review of the FDA Adverse Event Reporting System (FAERS) database and the medical literature to evaluate cases of serious skin reactions associated with acetaminophen (see Data Summary at link below). It is difficult to determine how frequently serious skin reactions occur with acetaminophen, due to the widespread use of the drug, differences in usage among individuals (e.g., occasional vs. long-term use), and the long period of time that the drug has been on the market; however it is likely that these events (i.e., SJS, TEN, and AGEP) occur rarely.

RECOMMENDATIONS: Health care professionals should be aware of this rare risk and consider acetaminophen, along with other drugs already known to have such an association, when assessing patients with potentially drug-induced skin reactions. Any patient who develops a skin rash or reaction while using acetaminophen or any other pain reliever/fever reducer should stop the drug and seek medical attention right away. Anyone who has experienced a serious skin reaction with acetaminophen should not take the drug again and should contact their health care professional to discuss alternative pain relievers/fever reducers.

FDA will require that a warning be added to the labels of prescription drug products containing acetaminophen to address the risk of serious skin reactions. FDA will also request that manufacturers add a warning about serious skin reactions to the product labels of OTC acetaminophen drug products marketed under a new drug application and will encourage manufacturers of drug products marketed under the OTC monograph do the same.

Read the complete MedWatch Safety Alert, including a link to the Consumer Update and Drug Safety Communication, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...
 

Acetaminophen常用於止痛與退燒，許多處方藥及非處方藥皆含有此成分。FDA提醒醫療人員及病人，acetaminophen可能造成罕見且嚴重的皮膚反應。這些皮膚不良反應包括Stevens-Johnson Syndrome (SJS)、toxic epidermal necrolysis (TEN)，acute generalized exanthematous pustulosis (AGEP)，上述不良反應可能發生於第一次或任何一次服藥後，嚴重時可能致命。其他止痛退燒藥品，如非類固醇抗發炎藥ibuprofen和naproxen，已於藥品仿單標註可能造成嚴重皮膚反應。

此資訊來自美國FDA不良反應通報系統資料及臨床上acetaminophen嚴重皮膚反應案例報告之統計。雖然，這些皮膚症狀應屬罕見副作用，但由於此藥使用十分廣泛且上市多年，並具有多種使用方式（需要時服用或長期服用），難以判別發生之頻率。

FDA將在acetaminophen等處方藥藥品仿單中新增可能出現嚴重皮膚反應風險之警語，同時也要求廠商將此標示於非處方藥之藥品仿單中。

醫療人員須了解acetaminophen有此罕見的風險。當病人可能出現藥物引起之皮膚反應時，應考量acetaminophen或其他相關藥物造成的可能性。病人服用acetaminophen或其他止痛退燒藥物產生嚴重皮膚反應時，應立即停藥並就醫。曾有服用acetaminophen造成嚴重皮膚反應之經驗的病人，應立即告知醫師，避免再次服用此藥，並更換其他止痛發燒的藥品。

相關訊息與連結請參考FDA網址：http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm363519.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