The FDA said it had received reports of allergic-type reactions potentially related to sulfite-containing compounded drugs. Noting that healthcare professionals and patients might be unaware of sulfite allergies and sensitivities, the agency said it opted to send out an alert.
“FDA encourages patients with known sulfite allergies or sensitivities to discuss them with their healthcare professional,” according to the agency. “Patients and healthcare 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.”
Background information in the alert noted that sulfites are substances that may be added to certain drug products as preservatives to help prevent the active drug ingredient from breaking down and becoming less effective. Examples of specific sulfites include:
• Sodium bisulfite
• Sodium metabisulfite
• Sodium sulfite
• Potassium bisulfite
• Potassium metabisulfite.
“Studies have demonstrated that sulfites may cause allergic-type reactions in susceptible people, especially patients with asthma,” the FDA pointed out. “Allergic-type reactions may include anaphylactic symptoms and life-threatening or less severe asthmatic episodes in susceptible people.”
FDA-approved prescription drugs containing sulfites are required to include a warning statement in the product labeling.
Federal drug regulators have 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 (pink eye)
• Itchy eyes and swollen eyelids
• Respiratory failure (breathing difficulty with low blood oxygen).
Compounded drugs are not FDA-approved, which means FDA has not evaluated their safety, effectiveness, quality, or labeling prior to marketing.
The American Pharmacists Association says that about 7,500 of the around 56,000 pharmacies in the United States offer compounding services.
The content contained in this article is for informational purposes only. The content is not intended to be a substitute for professional advice. Reliance on any information provided in this article is solely at your own risk.
