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Selective Serotonin Reuptake Inhibitor (SSRI) Antidepressants: Drug Safety Communication - Use During Pregnancy and Potential Risk of Persistent Pulmonary Hypertension of the Newborn
Including Celexa (citalopram); Lexapro (escitalopram); Prozac, Sarafem, Symbyax (fluoxetine); Luvox, Luvox CR (fluvoxamine); Paxil, Paxil CR, Pexeva (paroxetine); Zoloft (sertraline); Viibryd (vilazodone)
AUDIENCE: Psychiatry, OB/GYN, Family Practice
ISSUE: FDA notified healthcare professionals and the public on the use of selective serotonin reuptake inhibitor (SSRI) antidepressants by women during pregnancy and the potential risk of a rare heart and lung condition known as P ersistent Pulmonary Hypertension of the Newborn (PPHN). The initial Public Health Advisory in July 2006 on this potential risk was based on a single published study. Since then, there have been conflicting findings from new studies evaluating this potential risk, making it unclear whether use of SSRIs during pregnancy can cause PPHN.
FDA has reviewed the additional new study results and has concluded that, given the conflicting results from different studies, it is premature to reach any conclusion about a possible link between SSRI use in pregnancy and PPHN. FDA will update the SSRI drug labels to reflect the new data and the conflicting results.
BACKGROUND: SSRIs are marketed under various brand and generic drug names, and are used to treat depression and other psychiatric disorders. There are no adequate and well-controlled studies of SSRIs in pregnant women.
PPHN occurs when a newborn baby does not adapt to breathing outside the womb. Newborns with PPHN may require intensive care support including a mechanical ventilator to increase their oxygen level. If severe, PPHN can result in multiple organ damage, including brain damage, and even death.
RECOMMENDATION: FDA advises health care professionals not to alter their current clinical practice of treating depression during pregnancy. See the Data Summary in the FDA Drug Safety Communication for additional information.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
* Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
* Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178?
Read the MedWatch safety alert, including a link to the FDA Drug Safety Communication, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...
FDA提醒醫護人員及大眾，懷孕婦女如果使用selective serotonin reuptake inhibitor (SSRI)，可能會有新生兒持續性肺高壓(Persistent Pulmonary Hypertension of the Newborn；PPHN)的風險。此風險是在2006年時基於一個公開發表的試驗而被提出的，從那時起，陸續有新的試驗對此風險有衝突的發現，這使得懷 孕婦女使用SSRI是否會導致PPHN更不明確了。
FDA評估新的試驗結果後，認為這些衝突的發現，還不足以定論此風險是否成立，但FDA將於SSRI藥品仿單中更新這些新試驗衝突的發現。
SSRI在市場上有許多廠牌，在臨床上被用於治療憂鬱症(depression)及其他精神疾患，但是目前對於懷孕婦女的安全性並沒有足夠且良好的臨床試驗可供參考。
PPHN發生在當新生兒無法適應在子宮外呼吸的情況，此時，新生兒可能需要積極照護，包括使用呼吸器來增加其血氧濃度等。如果情況嚴重，更可能造成包括腦部等多重器官損傷，甚至是死亡。
FDA建議醫護人員不要更改目前對懷孕婦女憂鬱症的治療，更多資訊請詳見FDA網站之Drug Safety Communication。
相關訊息與連結請參考FDA網址：
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...
[Posted 12/14/2011]
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1760期）