FDA OKs Levemir for pregnant women
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
Was the trial done on
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?