Diabetes drug for pregnant women released

Wed, 31 Jan 2007
The Food and Drug Administration have approved a new diabetes drug for pregnant women. The medication, known as NovoLog, comes with an attached safety precaution from the FDA that provides clear guidelines for physicians who are treating pregnant women.

The drug has advanced to something called a pregnancy category B rating under FDA policy . This means that enough clinical trials have been conducted on pregnant women who have type 1 diabetes to make sure that the drug has no risks for the unborn child. This is an upgrade from category C, which shows that the health of the foetus can be negatively affected in animal studies.

The category change comes following an extensive review of a clinical trial that used the drug amongst pregnant women. NovoLog was compared to regular insulin injections, and the two were found to be comparable. However, the risk of congenital malformations has not been established.

The drug outperformed HRI by showing fewer preterm deliveries, less neonatal hypoglycaemia, and lower risks for the foetus. The approval could be good news for diabetic women who are pregnant.
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