The FDA issued an alert on June 5 to health-care professionals, compounders and patients about the risk of potentially serious allergic-type reactions to sulfite-containing compounded drugs. In the alert, the FDA stated it received adverse event reports indicating allergic or allergic-type reactions potentially related to sulfite-containing compounded drugs, including compounded drugs for ophthalmic routes of administration. These reports include complaints of conjunctivitis, itchy eyes, swollen eyelids and respiratory failure (breathing difficulty with low blood oxygen).

The FDA says it encourages patients and health-care professionals with concerns about sulfite allergies or sensitivities to ask compounders about the presence of sulfites in the drugs they compound to minimize the risk of adverse reactions. The FDA also encourages compounders to indicate the presence of sulfites on product labels and/or include a sulfite warning statement, as this could help reduce the risk of adverse reactions in people with sulfite allergies or sensitivities.

Individuals with a sulfite allergy or sensitivity may be exposed to sulfites and may risk experiencing an allergic or allergic-type reaction if they are unaware of the presence of sulfites and the presence of sulfites is not indicated on the label of a compounded drug they use. The FDA recommends that patients, health-care professionals and compounders be aware of potential safety risks associated with the use of sulfite-containing compounded drugs.

The FDA encourages patients, health-care professionals and compounders to report adverse events or quality problems experienced with the use of compounded drugs to the FDA’s MedWatch Adverse Event Reporting program: Complete and submit the report online at MedWatch: The FDA Safety Information and Adverse Event Reporting Program or Download and complete the form, then submit it via fax at 1-800-FDA-0178.