The Key to FDA Use-In Pregnancy Rating system rates both rapid acting insulin lispro (Humalog) and aspart (Novolog) as category B. This category indicates that no evidence of risk to humans has been seen in what they term “adequate, well controlled studies of pregnant women.” Physicians routinely prescribed short-acting and intermediate-acting insulin in pregnancy before studies validated the safety of rapid-acting insulin. However, short-acting and intermediate-acting insulin do not carry a rating. Of the combination insulins, only lispro protamine/insulin lispro (Humalog Mix 75/25) carries a rating of category B. Other combination insulins are either not rated or are rated category C. Category C means that risk cannot be ruled out. Lastly, the long-acting insulins glargine (Lantus) and detemir (Levemir) carry a rating of category C.
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