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İlaçların gebelikte kullanımlarına dair risk iletişiminde yeni dönem: FDA gebelik risk kategorileri değişiyor

A new era begins in risk communication regarding drug use in pregnancy: Changes in FDA pregnancy risk categories

Journal Name:

  • Türkiye Aile Hekimliği Dergisi

Publication Year:

  • 2014
DOI: 
10.15511/tahd.14.04195

Key Words:

Keywords (Original Language):

Author NameUniversity of AuthorFaculty of Author
Abstract (2. Language): 
Twenty nine years after the introduction of Pregnancy Risk Categories, U.S. Food and Drug Administration (FDA) concluded that categories were not successful at conveying the possible risks of drug use in pregnancy. FDA announced its second generation approach to labeling drugs for use in pregnancy and lactation with the publication of Proposed Rule for Pregnancy and Lactation Labeling for Human Prescription Drug and Biological Products on May 29, 2008. The proposed rule is designed as a narrative text containing elements such as fetal risk summary, clinical considerations and data. This manuscript aims to increase information and awareness of family practitioners on this subject.
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Abstract (Original Language): 
Amerikan Gıda ve İlaç Dairesi (FDA), gebelik risk kategorilerinin geliştirilmesi ve kullanıma sunulmasından 29 yıl sonra, mevcut risk kategorizasyonunun gebelikteki ilaç kullanımına dair riskleri tanımlamakta ve iletmekte yeterli olmadığına karar vermiştir. 29 Mayıs 2008’de Amerikan Resmi Gazetesi’nde yayınladığı yönetmelikle, FDA, ilaçların gebelik ve emzirme dönemindeki riskle-rine dair yeni bir anlatım metoduna geçileceğini, bu anlatımın “öyküleştirilmiş” şekilde olacağını, metnin risk özeti, klinik olarak göz önüne alınması gereken durumlar ve veriler gibi alanlara ayrılacağını duyurmuştur. Bu yazı ile aile hekimlerinin bu konudaki bilgi ve farkındalığının arttırılması amaçlanmıştır.
FULL TEXT (PDF): 
PDF icon arastirmax-ilaclarin-gebelikte-kullanimlarina-dair-risk-iletisiminde-yeni-donem-fda-gebelik-risk-kategorileri-degisiyor.pdf
  • 4
195
198
  • Turkish

REFERENCES

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