Kalydeco May Increase Cataract Risk for Kids

The Food and Drug Administration (FDA) announced that a recent animal study suggests that children who use a cystic fibrosis pill made by Vertex Pharmaceuticals may be at risk for developing cataracts.

The FDA has asked Vertex to update the drug’s label with that information and requested the company do a clinical study of children up to age 11 who take Kalydeco, according to Reuters.

Kalydeco is the first drug to treat the underlying cause of cystic fibrosis, a serious disease that affects the lungs and digestive system.

The animal study showed rats that were seven to 35 days old developed cataracts after being given a dose of Kalydeco that was about a tenth of the maximum recommended dose, according to Reuters.

The drug was approved in January for patients aged six and up who have a specific defective protein which causes cystic fibrosis in nearly 4 percent of patients.

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