Source: Reuters Health News
Area: News
The FDA has highlighted on its website the findings from a study in juvenile rats of the risk of developing cataracts with cystic fibrosis drug ivacaftor (Kalydeco). This information has been added to the label for Kalydeco which was approved in January for patients with cystic fibrosis aged six and older who carry the G551D mutation in the CF transmembrane regulator (CFTR) gene.
According to the study, rats aged 7 to 35 days old developed cataracts after being given a dose of Kalydeco that was about a tenth of the maximum recommended dose for people. However, the FDA stress that it is uncertain whether the finding in juvenile rats would apply to children. It has asked the company to conduct a clinical study of the risk of cataracts in children who are already taking ivacaftor up to 11 years of age, when eye development is generally complete. The children must be followed for at least two years and have eye examinations every six months.
The company still ...
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