Cüneyt Kemal BUHARALIOĞLU, Gökçe YILDIRIM BUHARALIOĞLU

Talidomit faciasının farmakovijilans etkinliklerinin gelişimi üzerine etkisi

Bu derlemede, tarihsel bir yaklaşımla, talidomit kullanan gebelerin fokomelili bebeklerinin doğumu sonrasında yaşananlar değerlendirilerek, bu facianın sistematik farmakovijilans etkinliklerinin gelişimine etkisi araştırılmıştır. Bu amaçla, ilgili anahtar kelimeleri içeren PubMed taraması yapılarak çalışmamızın amacı ile uyumlu bilimsel makaleler ve tarihsel bilgileri içeren derlemeler çalışmamıza dahil edilmiştir. Bulgularımız teratojenisite, ilaç güvenliliği ile ilgili etik ve yasal düzenlemeler, ilaçların geliştirilmesi ve pazarlama sonrası gözetimi gibi önemli farmakovijilans etkinliklerinin gelişiminde talidomit faciasının nasıl bir itici güç olduğunu vurgulamıştır. Talidomidin kütanöz lepranın ve multipl myelomanın tedavisinde kullanılmak üzere yakın geçmişte ilaç piyasasına geri dönüşü ilaç güvenliliğine bakış açımızı değiştirmiş ve risk yönetimini ön plana çıkartmıştır. Sonuç olarak; talidomit faciasının ardından yaşananlara günümüzün gözüyle bakmak, farmakovijilans etkinliklerini daha iyi anlamamızı sağlamakla birlikte önümüzdeki yıllarda farmakovijilansı bekleyen zorlukları belirleyip çözmemize yardımcı olma potansiyelini de taşımaktadır.

Anahtar Kelimeler:

farmakovijilans, Talidomit, farmakovijilans, ilaç güvenliliği

Effects of thalidomide disaster on the development of pharmacovigilance activities

In this review, the effects of thalidomide babies on the development of systematic pharmacovigilance activities were searched with historical perspective. For this purpose, after PubMed search with relevant keywords, scientific studies that serve our purpose were included and historical information was obtained from the reviews. Our results underlied the fact that thalidomide disaster was the main driving force for the development of important pharmacovigilance activities such as teratogenicity, ethical and legal regulations on drug safety, drug development and post-marketing drug surveillance. Currently, the return of thalidomide in the treatment of cutaneous leprosy and multiple myeloma has changed our view on drug safety and highlighted the importance of risk management. As a result, looking at the thalidomide disaster from today’s perspective will help us not only to better understand pharmacovigilance activities but also to identify and solve the challenges that are waiting in the coming years.

Keywords:

Thalidomide, pharmacovigilance, drug safety,

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