FDA Actions
June 1, 2015 less than 1 minute read
The FDA has approved the first spray-dried fibrin sealant to help control bleeding during surgery. The product contains fibrinogen and thrombin obtained from human blood products. The approval of fibrin sealant was based on a study of 719 participants undergoing different types of surgical procedures showing a reduction in the time needed for bleeding to stop compared to using absorbable sponges alone. Fibrin sealant (human) is manufactured by ProFibrix BV and marketed as Raplixa.
The FDA has issued a warning regarding a class of type 2 diabetes medications and the risk for ketoacidosis. The drugs are SGLT2 inhibitors and include canagliflozin (Invokana), dapagliflozin (Farixga), and empagliflozin (Jardiance). SGLT2 inhibitors block the sodium glucose co-transporter-2, which allows sugar to be excreted in the urine, thus lowering blood sugar levels. The FDA Adverse Event Reporting System database identified 20 cases of acidosis reported as diabetic ketoacidosis, ketoacidosis, or ketosis in patients treated with SGLT2 inhibitors from March 2013 to June 6, 2014. The FDA is warning patients who take these medications to look for signs and symptoms of ketoacidosis. The agency is also asking physicians to report adverse effects through the MedWatch program.
The FDA has approved the first spray-dried fibrin sealant to help control bleeding during surgery.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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