FDA Warns Against Use of Budesonide Nasal
On September 27, 2013, the FDA announced that it was recommending against the use of budesonide nasal irrigation solution from The Compounding Shop after confirming that the product may contain fungus.
In mid 2013, PMSI alerted you about the voluntary recall of all sterile products from The Compounding Shop, a compounding pharmacy located in Florida, following concerns over lack of sterility assurance and quality control processes. As of September 27, 2013, the FDA is warning all patients and healthcare providers to discontinue the use of any budesonide nasal irrigation solution from the compound pharmacy as fungus in the form of white, floating material was observed in certain stock solutions. Budesonide is an anti-inflammatory agent (i.e. corticosteroid) that can be used via a number of administration routes including nasal/oral inhalation/oral use for the treatment of allergic rhinitis, asthma, and other inflammatory conditions. The use of products containing active fungus spores can cause serious fungal infections, particularly in patients with compromised immune systems.
All products compounded and distributed by The Compounding Shop were previously recalled as of May 5, 2013; however, the FDA wants to ensure that any remaining stocks of budesonide nasal solutions are quarantined immediately due to recent findings. Although some patients may suffer from industrially-related asthma and other respiratory conditions, the availability of alternative anti-inflammatory agents for similar indications will limit the global impact of this FDA announcement.
At this point in time no action is necessary on behalf of workers’ compensation payers. Given the large number of
compounding pharmacies in operation nationwide, PMSI will continue to monitor the FDA’s website and keep you
informed of any updates pertaining to the safety and well-being of workers’ compensation patients. References
The Compounding Shop: FDA News Release – Lack of Sterility Assurance of Drug Products. FDA MedWatch. <Accessed September 30, 2013>
The Compounding Shop: FDA News Release – Lack of Sterility Assurance of Drug Products. FDA MedWatch. <Accessed May 9, 2013>
This publication is provided as reference material and is based in part on information derived from third parties. PMSI does not assume liability or
responsibility for the accuracy or completeness of any third-party material in this document. The information contained herein should not be construed
as an endorsement of any kind. This document is advisory in nature only and does not replace sound clinical judgment or individualized patient care in
th e delivery of drug therapy. PMSI — Proven Solutions for Cost Containment. Founded in 1976, PMSI is a leader in developing solutions to control the growth of medical costs in
w orkers’ compensation. As one of the nation’s largest and most experienced companies focused solely on workers’ compensation, we deliver proven
solutions for cost containment across the claims lifecycle. PMSI’s Pharmacy, Critical Care, and Settlement Solutions products deliver quantifiable results
and improve the quality of care for injured workers. We provide our customers with the innovation, focus, expertise, analytics and technology needed to
successfully deliver workers’ compensation benefits.
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