關於抗精神病藥物安全性的最新資訊 Latest safety update on antipsychotics

       美國食物及藥物管理局(USFDA)對孕婦於懷孕第三期服用抗精神病藥物出現的不良反應報告進行了截至2008年10月的上市後回顧研究, 結果發現68名新生兒出現錐體外症狀或戒斷症狀, 包括激動﹑張力過高﹑肌無力﹑震顫﹑嗜睡﹑呼吸抑制和飼養障礙。當中部分新生兒的錐體外症狀和戒斷症狀在不需處理的情況下於數小時或數天內消失, 然而部分新生兒需要住院治療, 甚至延長住院時間。基於上述結果, 現提醒醫生﹑藥劑師及其他衛生專業人士:

1. 當孕婦於懷孕第三期服用抗精神病藥物時, 注意胎兒可能吸收部分藥物, 而導致出生後的新生兒出現錐體外症狀或戒斷症狀。因此, 醫生應監測新生兒可能出現的錐體外症狀或戒斷症狀;

2. 對於正在服用抗精神病藥物的孕婦, 應對她們作風險-效益評估;

3. 由於可能出現嚴重的副作用, 對於將要懷孕的婦女, 提醒她們不要在沒有告知醫生的情況下, 自行停止服用抗精神病藥物, 對於正在懷孕的婦女, 亦不可突然停止服用抗精神病藥物。

       Result from the United Stated Food and Drug Administration(USFDA) postmarketing reviews on ADR reports up to October 2008 subsequent to the use of antipsychotics on pregnant mothers at their third trimester of pregnancy identified 68 cases of neonatal extrapyryramidal signs(EPS) or withdrawal symptoms in newborns. Symptoms exhibited by the  newborns include agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder. In some of the exposed neonates EPS or withdrawal symptoms subsided within hours or days without treatment, while others may require hospital attention or even extended hospitalization.  In light of the above we would recommend the following advice for physicians, pharmacists, and other healthcare professionals:

1. when antipsychotic medications were given to mothers at their third trimester of pregnancy, fetal exposure would predispose the neonates in developing EPS or withdrawal symptoms following delivery.  Hence, clinicians should monitor neonates for EPS or withdrawal symptoms;

2. counsel patients about the benefits and risks of taking antipsychotic drugs during pregnancy;

3. remind them not to stop taking the antipsychotic medication without first talking to their physician if they are pregnant and not to abruptly stop their antipsychotic medication during pregnancy because this could cause significant complications in their treatment conditions.

 

參考資料/Reference and website:

https://www.fda.gov/Drugs/DrugSafety/ucm243903.htm


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