J. Beach, A. M. Blair, A. Clarke
Mar 15, 1981
Citations
1
Influential Citations
12
Citations
Quality indicators
Journal
Toxicology and applied pharmacology
Abstract
Abstract The safety evaluation of cromolyn sodium (sodium cromoglycate) included 20 separate toxicity studies in rhesus, cynomolgus and stump-tailed macaques, baboons, and squirrel monkeys. The studies were performed to help evaluate the safety for humans of the use of the compound by dry powder inhalation for the treatment of asthma and by application to the eyes and nose in the treatment of conjunctivities and rhinitis. A previously unreported vascular lesion, the occurrence of which in these studies was responsible for a considerable extension of the safety evaluation program, was eventually shown to be unrelated to cromolyn sodium treatment. The only significant toxic effect was renal damage due to blockage of tubules with precipitated compound. This was confined to injection studies, where large multiples of the therapeutic dose were given. These studies demonstrate an adequate safety margin between the therapeutic dose of cromolyn sodium and the lowest dose needed to produce this effect. No cromolyn sodium-induced toxicity was seen in studies using the prescribed therapeutic routes.