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FDA Authorizes NovoLog for Pregnant Women With Type 1 Diabetes

Feb 6, 2007

NovoLog has now been given a pregnancy category B rating, indicating that adequate studies in pregnant women with type 1 diabetes have demonstrated that NovoLog does not increase risk to the unborn baby.

As a safety precaution, the FDA classifies prescription drugs with specific category ratings to provide guidelines for physicians treating pregnant women.

Previously, NovoLog was classified as a category C rating, which indicates that adverse effects on the fetus have been demonstrated in animal reproduction studies, and that studies in pregnant women have not been conducted to demonstrate safety.

The FDA category change was based on a review of a trial using an insulin analog in pregnant women with type 1 diabetes. The study compared the safety and efficacy of NovoLog versus human regular insulin (HRI). Data demonstrated that changes in HbA1c and rates of maternal hypoglycemia were comparable with NovoLog compared to HRI. The study was not large enough to evaluate the risk of congenital malformations.

Compared to HRI, the trial with NovoLog showed improved outcomes for both mother and child in terms of fewer preterm deliveries, reduced risk of neonatal hypoglycemia requiring treatment, consistently low rates of major hypoglycemia and reduced risks to the fetus.