Paroxetine - The Teratogenic Effect by Bob Fiddaman

[fiddaman]

I can't be bothered to embed all the links folks and it's rather a long post. So if you wish to read the full article,click on the link after the first few para's.

Now there's a word, "Teratogenic" - one most of you will be unaware of - one that has caused me considerable confusion over the past few weeks. I shall explain.

The recent GSK vs Kilker case saw files flood the Internet, many of which, if not all, are featured on this blog and my sister blog, GlaxoSmithKline Internal Files

What I find astounding is that this word, "Teratogenic" and/or "Teratogen" often appears throughout the Kilker files. A quick search of the word/s simplifies it into laymans terms:

Teratogenic: Able to disturb the growth and development of an embryo or fetus.

Teratogen: Any agent that can disturb the development of an embryo or fetus. Teratogens may cause a birth defect in the child. Or a teratogen may halt the pregnancy outright. The classes of teratogens include radiation, maternal infections, chemicals, and drugs.

What has caused me much confusion over the past few weeks is the lack of help I have received trying to find out more about the paroxetine [Paxil, Seroxat] and teratogen link.

The Kilker case files show a link between paroxetine and its teratogenic effect, such a strong link that the jury in that case found that paroxetine was the causation of young Lyam Kilker being born with heart defects.

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[Rachelina]

Fid, that was very interesting. Thanks for pushing so hard on this important issue. I wonder why no one would come out and say yes, it is a teratogen, since so many studies have shown this? The FDA has categories for pregnancy risk; Paxil is classified as D which means: There is positive evidence of human fetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective). The only category worse than D is X, which means it's completely contraindicated in pregnant women. So, the FDA recognizes it is a teratogen; is there a similar classification system in the UK? I think there is in Australia at least.

By the way have you, or anyone else, come across studies that mention how dosage affects risk? Dosage never seems to be mentioned in the studies I've seen. Due to my age and my having to taper extremely slowly, it looks like I will have to have a baby on 5 mg or not at all. My husband claims that 5 mg is ten times safer than 10 mg and 100 times safer than 20 mg, but I'm afraid he may be making this up since he really wants to have a baby. I'm really angry and broken-hearted about this whole issue - none of the options are good. Have a baby on Paxil, have a baby in my 40's (if I can) which has its own risks, or don't have one.

[fiddaman]

Thanks Rachel.

I'm surprised at the length of time it takes for a regulator to answer a simple question, even more surprised at other 'regulatory bodies' telling me to ask my doctor. I'm not surprised at GSK not answering me - why admit they have a drug on the market that can harm the unborn?