levemir granted pregnancy category b classification

Reactions 1397 - 14 Apr 2012

Levemir granted pregnancyCategory B classification

The US FDA has granted Levemir [insulin detemir] apregnancy Category B classification, says Novo Nordiskin a media release dated 2 April 2012.

This classification indicates that Levemir does notincrease the risk of harm to the unborn baby when usedduring pregnancy. This label update makes Levemir thefirst and only basal insulin analogue to be given thisclassification. It follows a review of data from a large,randomised trial investigating the safety and efficacy ofLevemir compared with NPH insulin [insulin suspensionisophane] in pregnant women with type 1 diabetes. Thestudy found that Levemir was associated with similarreductions in glycated haemoglobin (A1C) levels as NPHinsulin at gestational week 36, and lower fasting plasmaglucose levels at weeks 24 and 36. Additionally, therewere no between-group differences with regard to theoverall safety profile during pregnancy, other pregnancyoutcomes, or the health of the fetus or newborn. Untilnow, NPH insulin has been considered the standard ofcare for diabetes in pregnancy.Novo Nordisk. FDA Approves Levemir Pregnancy Category Change for Womenwith Diabetes. Media Release : 2 Apr 2012. Available from: URL: http://www.novonordisk.com 809135423

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Reactions 14 Apr 2012 No. 13970114-9954/10/1397-0001/$14.95 © 2010 Adis Data Information BV. All rights reserved