Zantac Lawsuit


Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist

Friday, January 13, 2012

SSRi Birth Defects




An article in today's Daily Mail confirms what's been known for some time, at least by those in the know. The British drug regulator, the MHRA, seem to be ignorant on this matter or just prefer to bury their heads in the sand about it.

The Daily Mail's Jenny Hope opens her article with:


Women taking antidepressants such as Prozac during pregnancy are more likely to give birth to children with life-threatening high blood pressure problems, researchers say.


They found that the risk doubles among those taking selective serotonin reuptake inhibitors – the most heavily prescribed antidepressants – in late pregnancy.

I'm pretty passionate about this issue. I've made many friends during my time writing this old blog of mine, many of whom have first hand experience of SSRi related birth defects.

The Daily Mail has published something today that needs to be highlighted. A warning on a packet of pills claiming that taking a pill during pregnancy benefits any risk is merely a smokescreen to the real problem - a weak regulator who cannot/will not acknowledge the teratogen link in SSRi's.

The article mentions a study carried out by researchers at the Centre for Pharmacoepidemiology at Karolinska Institutet in Stockholm Sweden, who reviewed 1.6 million births in total between 1996 and 2007 in five Nordic countries: Denmark, Finland, Iceland, Norway and Sweden.

The study analysed several drugs, including Prozac and our old friend Seroxat, and findings showed that out of 11,014 mothers who used antidepressants in late pregnancy, 33 babies (0.2 per cent) were born with persistent pulmonary hypertension after assessment at 33 weeks.

SSRi birth defect litigation is rife in the US, to my knowledge no such litigation has been started in the UK. It's a sad state of affairs that women and infants have no protection from the UK drug regulator, an example of which becomes apparent when you read the classification of Seroxat in the US.

In the US, Paxil [Seroxat] is classed as a 'Class D' drug. This classification was given by the Food and Drugs Administration [FDA] - The FDA are the American equivalent of our MHRA. [Fig 1]

Fig 1


Furthermore, I have wrote to Seroxat manufacturers GlaxoSmithKline and asked them if Seroxat was a teratogen, their answer?

"GlaxoSmithKline works within the guidelines set out in the Code of Practice of the Association of the British Pharmaceutical Industry (ABPI). This does not allow us to provide advice on personal medical matters to individual members of the public so that we do not intervene in the patient/ doctor relationship by offering advice which properly should be in the domain of your doctor. We would therefore recommend you discuss your concerns with him or her."

The same question was put to the MHRA, their response could only be described as toothless. They would not admit, one way or the other that Seroxat was teratogenic. Their full response is in my book, The evidence, however, is clear...the Seroxat scandal.

I posed this question to both GlaxoSmithKline and the MHRA because items of interest were aired in a US birth defect trial regarding Seroxat.

This from the Kilker v GlaxoSmithKline Birth Defect Trial:

Doctor Sloot's paper demonstrated that Paxil [Seroxat] was a clear teratogen, that it was not just an effect of developmental or birth-weight related effect, that it was a direct teratogen, and that there was a spectrum of defects observed in rat embryos at low doses, establishing that it was a very potent teratogen, more teratogenic than cocaine and retinol, clear teratogens in their own right.

Court documents from the Kilker v GlaxoSmithKline trial, where Glaxo were found guilty of Seroxat being the causation of Lyam Kilker's heart defects, can be found HERE.

Only in America folks.

I get many hits from America on this blog, for those wishing to seek action against pharmaceutical companies who have knowingly put their infants at risk, I suggest the following websites where advice can be sought.

Antidepressant Birth Defects

Prozac Birth Defects

Celexa Birth Defects

Lexapro Birth Defects

You will learn that Baum Hedlund report far more birth defects related to SSRi drugs, defects not mentioned in today's Daily Mail article.

If any British law firms show an interest then I'll big them up on this blog too. Sadly, litigation against pharmaceutical companies in this country is proving to be extremely difficult. The MHRA's failure to acknowledge the teratogen link is proving to be pharma's 'ace up the sleeve'.

Fid

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
US & CANADA HERE OR UK FROM CHIPMUNKA PUBLISHING

AUSTRALIAN ORDERS HERE






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