Talidomit faciasının farmakovijilans etkinliklerinin gelişimi üzerine etkisi

Year 2019, Volume: 12 Issue: 1, 136 - 142, 28.04.2019

Cüneyt Kemal Buharalıoğlu , Gökçe Yıldırım Buharalıoğlu

https://doi.org/10.26559/mersinsbd.474682

Cited By: 2

Abstract

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. 

Keywords

farmakovijilans, Talidomit, farmakovijilans, ilaç güvenliliği

Effects of thalidomide disaster on the development of pharmacovigilance activities

Abstract

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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