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Thursday, January 10, 2013

New Zealand Drug Watchdog Issues Warnings For Most Antidepressants Regarding Birth Defects

Zyban, just one of many SSRi type medications associated with birth defects



New Zealand's drug watchdog, Medsafe, who are the equivalent of the FDA and MHRA, have just issued warnings to healthcare professionals across New Zealand regarding the use of antidepressant type medications during pregnancy.

The warnings come on the back of a recent epidemiological study that shows a possible increased risk of congenital cardiovascular malformations after exposure to bupropion (Zyban) in the first trimester of pregnancy.

Here's where it may get confusing for healthcare professionals and patients.

Zyban is used as a smoking cessation medication that apparently helps people quit smoking.

Zyban is also known as Wellbutrin, an antidepressant.

Medsafe is reporting that the datasheet is currently being updated with information regarding the use during pregnancy.

Meantime, Medsafe and  the Medicines Adverse Reactions Committee (MARC) have just completed a review of the risk of QT prolongation and/or Torsades de pointes (TdP) associated with antidepressants used in New Zealand.

The findings?





QT prolongation/TdP is a risk of treatment with most of the antidepressants, including tricyclic antidepressants, approved for use in New Zealand.

Minutes of the MARC meeting can be viewed here.

I suppose the next question should be if any of these drugs should be classed as teratogenic, the definition of which is, "of or relating to substances or agents that can interfere with normal embryonic development."

If, as Medsafe and MARC suggest, these medications can cause the above abnomalities in newborn babies then surely a warning label citing their teratogenicity dangers should be put in place. At the very least it would give expectant mothers fully informed consent.

There's a few chapters in my book that highlights the spat I had with the British drug regulator who still refuse to admit that Glaxo's paroxetine [Paxil/Seroxat/Aropax] is a teratogen.







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