21 March 2018
Regeneron Pharmaceuticals has ceased distributing certain batches of Eylea kits in the US as a precautionary measure after a spike in reports of intraocular inflammation linked to syringes contained within the kits.
While the company has not issued a formal recall of the affected batches, Regeneron Pharmaceuticals is discouraging practitioners from using the included syringes and clinicians are able to exchange the affected kits.
A spokesperson for Bayer confirmed that none of the affected syringe lots have been distributed outside of the US.
“In countries outside the US, aflibercept is provided in the form of a vial accompanied by a filter needle only. Syringes are not provided as part of the aflibercept presentation,” the spokesperson explained.
Reporting rates outside of the US have remained stable over time and there is no signal of an increased intraocular inflammation risk.
The statement emphasised that patient safety is of the “utmost importance” to Bayer.
“Bayer is continuing to monitor adverse events, including intraocular inflammation, and working with the various regulatory authorities to report all adverse events,” the spokesperson shared.
A Regeneron Pharmaceuticals statement issued after the spike in safety reports highlighted that the annual reporting rate of intraocular inflammation ranged from one to four cases per 10,000 injections.
“Although overall reporting rates remain within these historical ranges, increased reporting rates were noted with certain recent lots distributed in the US.”
The list of recalled US batches can be found here.
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