Screening Of Summary Of Product Characteristics Of Desloratadine (5 Mg) For Cardiovascular Safety

Research Article
Ozaydin Ayse Nilufer and Ozaydin Fuat Nihat
DOI: 
http://dx.doi.org/10.24327/ijrsr.2017.0808.0633
Subject: 
science
KeyWords: 
Desloratadine, Cardiovascular, Summary of Product Characteristics, Medicolegal, Mortality
Abstract: 

Objective: Antihistaminic drugs are frequently used in the treatment of allergic diseases. Secondgeneration antihistamines such as desloratadine are preferred because they are more reliable in terms of side effects. In this study, Turkey Summary of Product Characteristics of desloratadine was examined in terms of cardiovascular safety.

Methods: Desloratadine Summary of Product Characteristics has been obtained from Turkey, Food and Drug Association and European Medicines Agency web page, if not possible, from web sites of producers with non-profit organizations, and evaluated with current literature.

Results: Tachycardia, palpitations and QT prolongation are mentioned in the “undesirable effects” section of desloratadine Summary of Product Characteristics. No other side effect has been specified. However, some in vitro studies have shown that high-dose desloratadine interacts with cardiac muscar ini creceptors and may affect normal cardiac function. Moreover investigators have indicated that patients with cardiovascular disease should be monitored closely. Turkey Pharmaceutical and Medical Devices Agency Technical Pharmacology Commission has sent an announcement to producers of desloratadine in 2012 and stated that "the use of desloratadine in patients with cardiovascular problems requires careful observation" should be added to the “special warnings and precautions for use” of Summary Product Characteristics.

Conclusion: "Patients with cardiovascular disease using desloratadine should be closely monitored" should be written in the desloratad in Summary Product Characteristics. This warning will protect healthcare workers from medico legal responsibilities.