New safety recommendations for ethambutol and ciprofloxacin

In the spring of 2004, the United States Food and Drug Administration (Food and Drug Administration, FDA) approved a review of contraindications, precautions and adverse effects medicines for ethambutol and ciprofloxacin.

Ethambutol can cause a decrease in visual acuity to irreversible blindness due to the development of optic neuritis. Symptoms of retrobulbar neuritis include decreased visual acuity, color blindness and scotomas. These phenomena were noted in the initial absence of a diagnosis of retrobulbar neuritis. Other adverse drug reactions are allergic reactions, neutropenia, and pulmonary infiltrates with eosinophilia.

Ethambutol is contraindicated in patients with retrobulbar neuritis, unless clinical evaluation permits its use. It is also contraindicated in patients who cannot assess and report adverse vision organ events and changes in vision. This group includes young children and unconscious patients. Ethambutol is contraindicated in patients with known hypersensitivity to this drug.

The precautions concern the use of ethambutol in pediatric practice in children under 13 years of age, as well as in lactating mothers when excreting the drug with milk. The drug should not be taken within 4 hours of taking antacids containing aluminum hydrochloride, they reduce the average serum concentration of ethambutol and the rate of excretion by the kidneys.

FDA data have been obtained from cases of tendon rupture in patients receiving ciprofloxacin and other fluoroquinolones. The tendon ruptures resulted in long-term disability and required surgical repair. The risk of developing this adverse drug reaction is increased in patients taking glucocorticoids with fluoroquinolones, especially in the elderly. The FDA recommends that you stop taking ciprofloxacin if you have tendon pain or symptoms of inflammation.

Ciprofloxacin can also cause pseudomembranous colitis. In the mildest cases, the symptoms of the disease stop after stopping the drug. The treatment of moderate severity and severe cases involves replenishing the loss of fluid, electrolytes and proteins, as well as treatment with effective antibacterial drugs against C. difficile (vancomycin, metronidazole ).