Belcher Pharma Petitions FDA to Alter Epinephrine Warning Label

June 7, 2017

Belcher Pharmaceuticals petitioned the FDA to amend its warning requirements for epinephrine injectables containing sulfites.

The current labeling requirements were imposed in 1986 and are no longer accurate because the warning implies that the only alternatives to sulfite-containing epinephrine are non-epinephrine products, which is no longer true, Belcher said. For example, the FDA approved Belcher’s sulfite-free formulation of epinephrine hydrochloride injection in 2014.

The existing warning also is misleading because it implies allergic-type reactions common to sulfite use do not occur in sulfite-containing epinephrine products, Belcher said.

According to the company, no existing data suggests sulfite-containing epinephrine does not cause these reactions, and suggesting otherwise potentially puts sulfite-sensitive patients at risk.

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