Talidomit faciasının farmakovijilans etkinliklerinin gelişimi üzerine etkisi

Yıl 2019, Cilt: 12 Sayı: 1, 136 - 142, 28.04.2019

Cüneyt Kemal Buharalıoğlu , Gökçe Yıldırım Buharalıoğlu

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

Cited By: 2

Öz

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

Öz

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.

Anahtar Kelimeler

Thalidomide , pharmacovigilance , drug safety

Kaynakça

• 1. World Health Organization. The Importance of Pharmacovigilance. Erişim yeri: http://apps.who.int/medicinedocs/en/d/Js4893e/, Erişim tarihi: 2.10.2018.
• 2. Pharmacovigilance Risk Assessment Committee: PRAC strategy on measuring the impact of Pharmacovigilance activities. Erişim yeri: http://www.ema.europ a.eu/docs/en_GB/docum ent_libra ry/Other/2016/01/WC500 19975 6.pdf, Erişim tarihi: 2.10.2018.
• 3. James HK, Anthony RS. Thalidomide: The Tragedy of Birth Defects and the Effective Treatment of Disease. Tox Sci 2011;122(1); 1–6.
• 4. Mellin GW, Katzenstein M. The saga of thalidomide: neuropathy to embryopathy, with case reports of congenital anomalies. N Engl J Med 1962; 267: 1184–92.
• 5. Vargesson N. The teratogenic effects of thalidomide on limbs. J Hand Surg Eur 2018 Vol. 2018; 1753193418805249.
• 6. Schumacher HA. Comparison of the teratogenic activity of thalidomide in rabbits and rats. J Pharmacol Exp Ther 1968; 160; 189–199.
• 7. McFadyen R. Thalidomide in America: A brush with tragedy. Clio Medica 1976; 11: 79-93.
• 8. Lenz W. A short history of thalidomide embryopathy. Teratology 1988; 38: 203–15.
• 9. Smithells RW, Newman CHG. Recognition of thalidomide defects. J Med Genet 1992; 29:716-723.
• 10. Lenz W, Knapp K. Foetal malformations due to Thalidomide. German Med 1962;7:253–8.
• 11. McBride WG. Thalidomide and congenital abnormalities. Lancet. 1961; ii:1358.
• 12. Curran, W. The thalidomide tragedy in Germany: The end of a historic medicolegal trial. New Engl J Med, 1971; 284: 481-482.
• 13. Kelsey, F. Thalidomide update: regulatory aspects. Teratology 1988; 38: 221–226.
• 14. Lenz, W. Malformations caused by drugs in pregnancy. Am J Dis Child, 1966; 112: 99-106.
• 15. Lenz W. 1962. Thalidomide and congenital abnormalities [letter]. Lancet 279:303–305.
• 16. Newman CGH. The thalidomide syndrome: risks of exposure and spectrum of malformations. Clin Perinatol 1986; 13:555-573.
• 17. Vargesson N. Thalidomide-induced teratogenesis: History and mechanisms. Birth Defects Res C Embryo Today 2015; 105: 140 – 156.
• 18. Sheskin J. Thalidomide in the treatment of lepra reactions. Clin Pharmacol Ther 1965; 6: 303–306.
• 19. Sheskin J, Convit J. Results of a double blind study of the influence of thalidomide on the lepra reaction. Int J Lepr Other Mycobact Dis 1969; 37: 135–146.
• 20. D’Amato RJ, Loughnan MS, Flynn E, Folkman J. Thalidomide is an inhibitor of angiogenesis. Proc Natl Acad Sci USA 1994; 91: 4082–4085.
• 21. Kenyon BM, Browne F, D’Amato RJ. Effects of thalidomide and related metabolites in a mouse corneal model of neovascularization. Exp Eye Res 1997; 64: 971–78.
• 22. Uhl K, Cox E, Rogan R, Zeldis JB, Hixon D. Thalidomide use in the US: experience with pregnancy testing in the S.T.E.P.S. programme. Drug Saf 2006;29:321–329.
• 23. Patient Guide to (THALOMID REMS™) Risk Evaluation and Mitigation Strategy (REMS)™ Program. Erişim yeri: https://www.fda.gov/downloads/forindustry/userfees/prescriptiondruguserfee/ucm361111.htm, Erişim tarihi: 23.10.2018
• 24. Wells PG. A new target for thalidomide. Nat Chem Biol 2018;14(10):904-905.
• 25. YellowCard. Erişim yeri:https://yellowcard.mhra.gov.uk/monitoring safety/.Erişim tarihi: 20.10.2018.
• 26. Dally A. Thalidomide: was the tragedy preventable? Lancet 1998;351: 1197-1199.
• 27. Buharalioglu CK, Acar S, Erol-Coskun H, Küçüksolak G, Karadas B, Kaya-Temiz T, Kaplan YC. Pregnancy outcomes after maternal betahistine exposure: A case series. Reprod Toxicol 2018;79:79-83.
• 28. George J. Annas, JD, Sherman E. Thalidomide and the Titanic: Reconstructing the Technology Tragedies of the Twentieth Century. Am J Public Health 1999;89(1): 98-101.
• 29. Ahmed M, Hwang JH, Choi S, Han D. Safety classification of herbal medicines used among pregnant women in Asian countries: a systematic review. BMC Complement Altern Med. 2017;17(1):489.