繼本處於2008年發出的安全性通告指出, 腫瘤壞死因子-α (tumor necrosis factor-α, TNF-α)阻斷劑可引起多種機會性感染後, 美國食物及藥物管理局(USFDA)近期再對這類藥物新增兩類細菌感染的風險, 包括軍團菌(Legionella)和李斯特菌(Listeria)。由於TNF-α阻斷劑屬免疫抑制劑, 服用這類生物製劑的病人出現嚴重感染的風險較高。基於上述原因, 本處再次提醒醫生﹑藥劑師及其他衛生專業人士：
- 對處於慢性或重覆感染﹑以及潛在狀況使其易受感染的病人, 於開始使用TNF-α阻斷劑治療前, 應考慮其風險及效益；
- 65歲上的病人和併用其他免疫抑制劑的病人, 受感染的風險可能較高；
- 於開始TNF-α阻斷劑治療前以及治療期間, 應定期評估病人倘有的活性結核病和潛伏的感染；
- 對服用TNF-α阻斷劑的病人, 應監測嚴重感染症狀的出現；
- 對因具有侵入性真菌感染風險而出現全身性疾病症狀的病人, 應考慮使用經驗性的抗真菌治療方案。
多個流行病學研究指出, 懷孕首三個月使用血清素再回收抑制劑(serotonin reuptake inhibitor, SSRI)中的fluoxetine, 會增加新生嬰兒心臟缺陷的風險, 研究中自然條件下出現心臟缺陷的機率是每一百名孕婦中有一個, 而結果顯示使用fluoxetine的孕婦, 上述風險會增加至每一百名兩個。英國藥物管理局(MHRA)和歐盟藥物監測工作組回顧相關數據後, 總結出於懷孕早期使用fluoxetine可能增加胎兒心臟缺陷風險的程度與另一SSRI藥物--paroxetine*相近, 但目前未有足夠數據顯示其他SSRI類藥物具有同樣的風險。
Tumor necrosis factor-α blockers: update of risk of infection from Legionella and Listeria
Subsequent to the safety alert issued in 2008 on several types of opportunistic infections elicited by tumor necrosis factor-α (TNF-α) blockers, the United States Food and Drug Administration (USFDA) recently updated to include the risk of infection from two bacterial pathogens, Legionella and Listeria. Since TNF-α blockers are immunosuppressants, patients who take these biologic products are at increased risk of serious infections. In light of the above, we once more remind physicians, pharmacists and other health professionals:
- the risks and the benefits of TNF-α blockers should be considered prior to initiating therapy in patients with chronic or recurrent infection and patients with underlying conditions that may predispose them to infection;
- patients greater than 65 years old and patients taking concomitant immunosuppressants may be at greater risk of infection;
- prior to initiating TNF-α blockers and periodically during treatment, patients should be evaluated for active tuberculosis and tested for latent infection;
- patients should be monitored for signs and symptoms of serious infections while taking TNF-α blockers;
- empiric antifungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness.
Fluoxetine: may slightly increase risk of heart defects in babies
Some epidemiological studies suggest an increased risk of cardiovascular defects in newborn babies associated with the use of the serotonin reuptake inhibitor (SSRI) fluoxetine during the first trimester. The background (naturally occurring) incidence of congenital cardiac defects is approximately 1 per 100 pregnancies. The results suggest that the risk of this condition with the use of fluoxetine in pregnancy is in the region of 2 per 100 pregnancies. After reviewed by the British Medicines and Health products Regulatory Agency (MHRA) and European Pharmacovigilance Working Party, conclusion has been elucidated that use of fluoxetine in early pregnancy may cause a small increased risk of heart defects in the unborn child similar to the risk seen with another SSRI, paroxetine*. There are insufficient data at present to conclude whether there is a similar risk with other SSRIs.
*Currently United States Food and Drug Administration (USFDA) has classified all SSRIs as Pregnancy Category C except for paroxetine, which is a Pregnancy Category D medication due to its risk of causing heart defects in babies.