On June 6, 2024, the FDA warned patients and healthcare professionals of the potential danger of sulfites in compounded medications. Remember that prescription products that contain sulfites are required by law to contain a sulfite warning due to the potential for serious adverse events in patients who have sulfite allergies.
The warning (here) notes that the FDA has received numerous adverse event reports “of allergic-type reactions potentially related to sulfite-containing compounded drugs.” In addition, the Agency also notes that “[P]atients and health care professionals, using or prescribing compounded drugs, can also ask compounders about the presence of sulfites in the drugs they compound especially when there are concerns about sulfite allergies or sensitivities. FDA also encourages compounders to indicate the presence of sulfites on product labels, and/or include a sulfite warning statement, to minimize the risk of adverse reactions in individuals with a sulfite allergy or sensitivity.”
The Agency describes receiving reports of the following adverse drug events linked to compounded drugs:
- complaints of conjunctivitis (pink eye)
- itchy eyes
- swollen eyelids
- respiratory failure (breathing difficulty with low blood oxygen)
The onus in this case appears to be on the patient with known sulfite allergies or the provider who should (presumably) be aware of the patient’s allergies in order to take an active part in understanding whether compounded prescriptions the patient requires may contain sulfites or added sulfites. Perhaps it’s time for states to require a warning on all compounded drugs to which sulfites are added or present as part of the formulation?
