藥物警訊

Prescription and Over-the-Counter (OTC) Pain Medicines: Drug Safety Communication - FDA Review of Possible Risks of Pain Medicine Use During Pregnancy

AUDIENCE: OBGYN, Consumer

ISSUE: FDA is aware of and understands the concerns arising from recent reports questioning the safety of prescription and over-the-counter (OTC) pain medicines when used during pregnancy. As a result, FDA evaluated research studies published in the medical literature and determined they are too limited to make any recommendations based on these studies at this time. Because of this uncertainty, the use of pain medicines during pregnancy should be carefully considered. FDA urges pregnant women to always discuss all medicines with their health care professionals before using them.

Severe and persistent pain that is not effectively treated during pregnancy can result in depression, anxiety, and high blood pressure in the mother. Medicines including nonsteroidal anti-inflammatory drugs (NSAIDs), opioids, and acetaminophen can help treat severe and persistent pain. However, it is important to carefully weigh the benefits and risks of using prescription and OTC pain medicines during pregnancy.

BACKGROUND: The published studies FDA reviewed reported on the potential risks associated with the following three types of pain medicines used during pregnancy. See the FDA Drug Safety Communication Data Summary section for more information about these studies.

RECOMMENDATION: Healthcare professionals should talk with each patient about the benefits and risks of analgesic use during pregnancy, which may differ among patients and by treatment indication. Continue to follow the existing recommendations in current drug labels regarding the use of analgesics during pregnancy.

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

有關懷孕期間服用處方藥及非處方止痛藥之安全性議題，美國FDA經回顧研究文獻後，認為就目前有限的資料，無法給予任何建議。但也因安全性尚未確立，懷孕期間使用止痛藥物應更審慎評估。FDA建議孕婦使用任何藥物前皆應與醫療人員充分討論後再決定是否服用。

懷孕期間若未有效處理疼痛可能使孕婦產生憂鬱、焦慮和高血壓等症狀。止痛藥品如非類固醇類消炎止痛劑 (nonsteroidal anti-inflammatory drugs, NSAIDs)，鴉片類止痛劑 (opioids)及acetaminophem，可有效幫助緩解嚴重之持續性疼痛。然而懷孕期間若需使用這些藥品，皆應先權衡利弊。

背景

FDA回顧有關懷孕期間服用以下三種止痛藥品之研究文獻：1. 懷孕前期服用NSAIDs與流產之風險。2. 懷孕前三個月服用鴉片類止痛藥與新生兒出現腦部、脊椎或脊髓缺陷之風險。3. 懷孕期間服用acetaminophen與孩童產生注意力不足過動症（attention deficit hyperactivity disorder, ADHD）之風險。

FDA認為這些研究設計仍有部分限制，且研究結果不一致，無法給予定論。故暫不更改目前懷孕期間使用止痛藥物之建議。

建議

FDA建議醫療人員應依病人的症狀及適應症，告知懷孕期間使用止痛藥之利弊；並應遵照藥物仿單中對於懷孕期間服藥之指示與建議。

相關訊息與連結請參考FDA網址：http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm429604.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