US FDA warns on risks linked to sulfite-containing compounded drugs

[June 06, 2024]  (Reuters) - The U.S. Food and Drug Administration said on Wednesday it had alerted healthcare professionals, drug compounders and patients about the risk of allergic reactions to sulfite-containing compounded drugs.

The FDA said it had received reports of complaints of conjunctivitis or pink eye, itchy eyes, swollen eyelids and

breathing difficulty with low blood oxygen, potentially related to sulfite-containing compounded drugs.

It also said sulfites may cause severe allergic reactions and life-threatening or less severe asthmatic episodes in susceptible people.

"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," the regulator said.

Examples include sodium bisulfite, sodium metabisulfite, sodium sulfite, potassium bisulfite, potassium metabisulfite.

The regulator has asked compounders to indicate the presence of sulfites on product labels or include a sulfite warning statement.

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo

Compounded drugs are not FDA-approved, but sulfite-containing drugs approved by the regulator are required to include a warning statement on their labels.

Drug compounding is the process of combining, mixing, or altering ingredients to create a medication tailored to the needs of an individual patient, the FDA said.

(Reporting by Puyaan Singh in Bengaluru; Editing by Anil D'Silva)

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