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Expert Opin Drug Saf. 2016 Nov;15(11):1483-1489. Epub 2016 Aug 17.

The safety of new drug treatments for idiopathic pulmonary fibrosis.

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a Department of Respiratory Medicine , University Hospital Southampton , Southampton , UK.
b Southampton NIHR Respiratory Biomedical Research Unit , University Hospital Southampton , Southampton , UK.
c Academic Unit of Clinical and Experimental Sciences, University of Southampton Faculty of Medicine , University Hospital Southampton , Southampton , UK.


The management of idiopathic pulmonary fibrosis (IPF) has been transformed by the recent approval of two anti-fibrotic drugs, nintedanib and pirfenidone. An increasing number of patients with IPF are receiving treatment with these novel therapies, and the risk of adverse events that may be associated with their use must be carefully evaluated. Areas covered: Safety data about nintedanib and pirfenidone is critically evaluated, including data from randomized clinical trials and post-marketing reports. Management strategies to minimize the occurrence of side effects are summarized. Expert opinion: The safety profile of the two anti-fibrotic drugs approved for clinical use in IPF patients appears to be comparable. Data from clinical trials and initial post-marketing surveillance indicate that most of the observed side effects are mild and easily manageable. However, approximately 1/5 of patients may discontinue treatment as a consequence of side effects. Careful patient counselling, and regular follow-up during therapy could reduce the rate of discontinuations. Ongoing post-marketing surveillance may further inform our understanding of the safety profile of these therapies.


Idiopathic pulmonary fibrosis; nintedanib; pirfenidone; safety

[Indexed for MEDLINE]

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