Journal of Pharmacovigilance

Abstract

Treprostinil: Safety Signal Detection Based on Adverse Event Reporting System Database

Shraddha Shinde

Objective: To examine the association between treprostinil sodium and pneumonia in patients with pulmonary arterial hypertension, utilizing and analyzing the reports submitted to the Food and Drug Administration (FDA) Adverse Even Reporting System (AERS) and the published literature.

Methods: A total of 5,332926 reports of adverse events between January 2006 and June 2012 were downloaded from the FDA AERS. These adverse events were associated with all other drugs inclusive of Treprostinil Sodium. A literature review was conducted on PubMed using the terms treprostinil and pneumonia. Authorized pharmacovigilance tools were used to determine the proportional reporting ratio, the reporting odds ratio, and the information component given by the Bayesian confidence propagation neural network.

Results: Based on the numerous adverse event pairs, 144 adverse events were listed as treprostinil sodium associated with pneumonia. The majority of the cases were seen in females (74%) and those between the ages of 51 and 75 years (63%). The most common route of drug administration among the cases was inhalation (73%).

Conclusion: This study helps indicate an association between the treatment with Treprostinil sodium and the development of pneumonia in pulmonary hypertensive patients. Additional research is needed to confirm with the medical relevance of the analysis.