The Food and Drug Administration has been considering whether to approve Covidien’s injectable booster shots of the hormone hormone prolactin for American women in the second trimester of pregnancy, but the company has appealed to regulators to order coverage for all pregnant patients, because women with early-stage gestational diabetes already get regular injections of the hormone to curb the effects of gestational diabetes.
In its request to the F.D.A., the company cited work by many leading scientific groups, and Jennifer Blanning, chief scientific officer of the American Diabetes Association, who called the booster shots “one of the most helpful tools for women with gestational diabetes.”
Covidien’s current application requires patients to receive high-dose doses of the hormone nine times a week, at the same time as receiving FDA-approved shots of prednisone and prednisolone. That would become the standard of care for women with early-stage gestational diabetes.
“There are approximately 300,000 women a year who contract gestational diabetes before 40 weeks of pregnancy, and by putting that woman at risk, we are putting not only her family, but also our society, at risk,” Sally Satel, senior medical fellow at the Yale Program on Women’s Health at Yale School of Medicine, told Reuters.
The F.D.A. is reviewing the company’s application.