Levemir Assigned More Reassuring Pregnancy Risk Category

Disclosures

April 02, 2012

April 2, 2012 — The US Food and Drug Administration (FDA) on March 29 gave insulin detemir (rDNA origin) injection (Levemir, Novo Nordisk) a more reassuring risk category for pregnant women with diabetes.

Before then, the FDA had assigned insulin detemir to pregnancy category C, which means that animal reproductive studies have shown an adverse effect on the fetus, there are no adequate and well-controlled studies in humans, and potential benefits may warrant the drug's use in pregnant women despite potential downsides.

Insulin detemir is now in pregnancy category B. Drugs receive this rating if adverse effects emerge in animal studies, but adequate and well-controlled trials with pregnant women fail to demonstrate a risk to the fetus during the first trimester, and there is no evidence of risk in later trimesters.

The FDA upgraded the drug to category B on the basis of a trial involving 310 pregnant women with type 1 diabetes, with roughly half of the women taking insulin detemir and the other half taking neutral protamine Hagedorn insulin, which had been considered the standard of care for diabetes in pregnancy, according to Novo Nordisk. Both groups achieved similar reductions in hemoglobin A1c levels, and the women using insulin detemir did not experience an increased risk for fetal abnormalities, according to the FDA's updated drug label. The most common adverse reactions were the common cold and headache.

The FDA's decision follows the approval last December of insulin detemir for pregnant women by the European Medicines Agency, the equivalent of the FDA in the European Union.

In a press release issued today, Novo Nordisk said insulin detemir is the first and only basal insulin analogue to have category B classification.

The drug's revised label acknowledges that good glucose control can lower the risk for adverse events in pregnancies complicated by hyperglycemia. However, the patient information section of the label sounds a cautionary note, stating that "it is not known if Levemir would harm your unborn baby," and "it is not known if Levemir passes into breast milk."

The FDA originally approved insulin detemir for adult patients with diabetes in 2005.

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