Australian Birth Defects Society

A Society devoted to the study of birth defects

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6 October 2016

ENTIS members question warning on paternal use of mycophenolate mofetil

Australia as well as European (but not FDA) labels contain the warning ”Sexually active men are recommended to use condoms during treatment and for at least 90 days after cessation of treatment”. ENTIS argues that the available data does not suggest any reproductive risk increase following paternal exposure. As well, human data from the United States National Transplantation Registry and a large Norwegian study does not suggest any such risk.

 

 

 

Zika virus and Pregnancy (updated 4 February 2016)

This report from OTIS will be updated at the The Teratology Society’s annual scientific meeting in June.

 

Education tool launched

 

 

28 June 2016

Monitoring the health impacts of mandatory folic acid and iodine fortification 2016

 

The findings into the impact of the mandatory introduction of folic acid and iodine as ingredients in bread production has just been released.

The report shows that neural tube defects, such as spina bifida, have declined 14.4% since the government initiative was introduced in 2009. The biggest changes were observed in teenagers (55% decrease) and Aboriginal and Torres-Strait Islander women (74% decrease)

12 June 2015

 

New FDA Draft Guidance on Male-Mediated Developmental Risk for Pharmaceuticals

 

The FDA has published a new Guidance for Industry on the Assessment of Male-Mediated Developmental Risk for Pharmaceuticals.

Page updated 30 August 2016