Safety Alert: Boron additives in Chloramphenicol drops; should ophthalmologists be concerned?
Boric acid and disodium tetraborate are used as excipients in a number of medicines for their antimicrobial and buffering properties. Toxicity studies in rats identified that testicular toxicity leading to reduced fertility occurs at doses below that which result in damage to other organs. As a result, the European Medicines Agency (EMA) has recommended upper limits on the daily exposure to boron-containing excipients, expressed as equivalent doses of elemental boron. For children under 2 years, the limit is 1mg per day and for children aged 2-12 years, the limit is 3mg per day. (Reference: EMA/CHMP 619104/2013).