FDA is raising awareness for patients and health care providers about the risk of potentially severe allergic-like reactions to compounded drugs that contain sulfites.
Research shows that sodium bisulfite, potassium metabisulfite, and similar agents, which typically are added as preservatives to prevent the breakdown of active ingredients in a drug, can trigger anaphylactic symptoms in susceptible individuals, especially those with asthma.
FDA has received reports of eye-related issues such as conjunctivitis, itchy eyes, and swollen eyelids, and respiratory failure in users of compounded drugs with sulfites.
The agency’s guidance is for patients with known sulfite sensitivity or allergy to share that information with their physician and for providers and patients to ask compounders about the use of sulfites in their products.
For their part, compounders are asked to note the presence of sulfites on drug labels or include a warning statement.