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Valproate Anti-Seizure Products: Drug Safety Communication - Contraindicated for Pregnant Women for Prevention of Migraine Headaches
Including valproate sodium (Depacon), divalproex sodium (Depakote, Depakote CP, and Depakote ER), valproic acid (Depakene and Stavzor), and their generics
AUDIENCE: Health Professional, Neurology, Pharmacy, Patient
ISSUE: FDA is advising health care professionals and women that the anti-seizure medication valproate sodium and related products, valproic acid and divalproex sodium, are contraindicated and should not be taken by pregnant women for the prevention of migraine headaches. Based on information from a recent study, there is evidence that these medications can cause decreased IQ scores in children whose mothers took them while pregnant. Stronger warnings about use during pregnancy will be added to the drug labels, and valproate’s pregnancy category for migraine use will be changed from "D" (the potential benefit of the drug in pregnant women may be acceptable despite its potential risks) to "X" (the risk of use in pregnant women clearly outweighs any possible benefit of the drug).
Valproate products will remain in pregnancy category D for treating epilepsy and manic episodes associated with bipolar disorder.
BACKGROUND: Valproate products are approved for the treatment of certain types of epilepsy, the treatment of manic episodes associated with bipolar disorder, and the prevention of migraine headaches. They are also used off-label (for uses not approved by FDA) for other conditions, particularly other psychiatric conditions.
This alert is based on the final results of the Neurodevelopmental Effects of Antiepileptic Drugs (NEAD) study showing that children exposed to valproate products while their mothers were pregnant had decreased IQs at age 6 compared to children exposed to other anti-epileptic drugs. For additional details, see the Drug Safety Communication Data Summary section.
RECOMMENDATION: Valproate products should not be used in pregnant women for prevention of migraine headaches and should be used in pregnant women with epilepsy or bipolar disorder only if other treatments have failed to provide adequate symptom control or are otherwise unacceptable.
Women who are pregnant and taking a valproate medication should not stop their medication but should talk to their health care professionals immediately. Stopping valproate treatment suddenly can cause serious and life-threatening medical problems to the woman or her baby.
Read the MedWatch safety alert, including a link to the Drug Safety Communication, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...
FDA通知醫療專業人員及婦女，抗癲癇藥品valproate sodium和其類似成分valproic acid及divalproex sodium，禁止用於預防孕婦之偏頭痛症狀。依據最近的研究，證實母親若於懷孕期間服用此藥，可能會降低兒童智商，這些警語將會加入藥品仿單。 valproate使用於偏頭痛之懷孕分級將由D級(已證實對人之胎兒有傷害，若是疾病對於孕婦有生命威脅或安全的藥品已無法治療的情況下，權衡利弊，仍 可使用)下修為X級(動物或人體的試驗中或使用經驗發現對胎兒有害，而造成的傷害明顯大於可能的益處)。使用於治療癲癇與躁症之懷孕分級仍維持D級。
Valproate經FDA核准於治療特定類型之癲癇症，躁症及預防偏頭痛。也有被用於其他非FDA核准適應症之精神疾病。
此警訊為依據抗癲癇藥物對神經發育影響(NEAD)之研究結果。該結果顯示，母親懷孕期間曾服用valproate之六歲兒童，與服用其他抗癲癇藥品之同年齡兒童相比，其智商較低。
依據以上資訊，valproate 不應用來預防孕婦之偏頭痛，只適用於當孕婦之癲癇或躁症無法以其他治療提供適當的症狀控制或不適用於其他方法治療時。正在服用valproate之孕婦不 應自行停藥，應立即與醫療人員聯絡。突然停藥可能會增加孕婦及胎兒產生嚴重且危及生命之風險。
相關訊息與連結請參考FDA網址：
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...
[Posted 05/06/2013]
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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資料來源：藥師週刊（第1824期）