The FDA accepts the first oral drug to lower blood for children


(HealthDay): The first oral drug to lower blood for children was approved by the U.S. Food and Drug Administration, the agency announced Monday.

Pradaxa oral granules (dabigatran etexilate) were approved for treatment with children from 3 months to 12 years (VTE) directly after treatment with an injectable anticoagulant for at least five days. The tablets were also approved to prevent recurrent clots among children in this age group who have completed treatment for their first VTE. The capsule form of Pradaxa was also approved for these indications in patients from 8 years of age.

Approval was based on safety and efficacy data from an open-label study of 267 who were randomly assigned to receive Pradaxa or standard of care. 45.8% of patients randomly assigned to Pradaxa and 42.2% of patients randomly assigned to standard care reached the endpoint of non-recurrence of blood clots, major and minor bleeding, or death. . Safety data were derived from an open-label single-arm study of 214 patients with a history of blood clots. Recurrence of blood clots occurred in three patients (1.4 percent), which was comparable to that observed with standard care.

The most common side effects of Pradaxa were symptoms of the digestive system and bleeding. The FDA notes that the drug can also cause severe and fatal bleeding. Not recommended in patients with heart valve bioprosthesis or triple positive antiphospholipid syndrome. A boxed warning on the prescription label warns that early discontinuation of treatment could increase the risk of suffering from it .

Approval was granted to Boehringer Ingelheim.

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