FDA OKs Levemir for pregnant women

FDA decision based on 310-patient clinical study

NEW YORK — A diabetes treatment made by Novo Nordisk is safe for pregnant women, according to a recent decision by the Food and Drug Administration.

Novo Nordisk said Monday the FDA had approved Levemir (insulin detemir [rDNA origin]) for a pregnancy category B classification, meaning that when used by pregnant women, the insulin did not increase the risk of harm to fetuses. The agency's decision was based on results of a clinical trial involving 310 women that compared Levemir to another insulin product.

The insulin is used to treat Type 1 and Type 2 diabetes.


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Comments

- 5:47 AM
Htaylor1 says

Was the trial done on pregnant women as well? Wouldn't that pose a considerable risk to the mother and child? For an untested drug that could potentially harm the fetus, were the mothers involved in the trial aware of the risks?

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