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Medications and Acute Hemolysis in G6PD-Deficient Patients - A Real-World Study
Naomi Gronich1,2, Bar Rosh2, Nili Stein1
1Department of Community Medicine and Epidemiology, Lady Davis Carmel Medical Center, Haifa, Israel.
Clinical Pharmacology and Therapeutics
|June 6, 2024
Summary
Many medications previously thought risky for glucose-6-phosphate dehydrogenase (G6PD) deficient patients were safely prescribed in a real-world study. This finding offers reassurance regarding the safe use of these drugs in G6PD deficiency.
Area of Science:
- Pharmacovigilance
- Hematology
- Genetics
Background:
- Drug labels often warn against use in glucose-6-phosphate dehydrogenase (G6PD) deficiency due to hemolysis risk.
- These warnings are frequently based on limited clinical or epidemiological data.
Purpose of the Study:
- To evaluate the actual risk of hemolysis in G6PD-deficient patients prescribed medications with suspected hemolytic potential.
- To provide real-world evidence on drug safety in this patient population.
Main Methods:
- Retrospective analysis of a large healthcare database (Clalit Health Services) including over 31,000 G6PD-deficient patients.
- Identification of hospitalizations for hemolysis and validation of cases.
- Cross-referencing of medication prescriptions for G6PD-deficient patients without hemolysis.
Main Results:
- Only 0.2% of G6PD-deficient patients experienced major hemolysis, with fava beans being the most common cause.
- Three cases of hemolysis were potentially linked to medications (nitrofurantoin, phenazopyridine, pain killer).
- Numerous G6PD-deficient patients safely received medications like nitrofurantoin, ciprofloxacin, and sulfamethoxazole/cotrimoxazole, previously considered risky.
Conclusions:
- Many medications previously flagged for hemolysis risk in G6PD deficiency appear safe for use in real-world practice.
- This study provides crucial data to potentially revise drug labeling and inform clinical prescribing decisions.
- Findings offer reassurance to patients, healthcare providers, and regulatory bodies regarding drug safety in G6PD deficiency.
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