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Sunday, May 16, 2010

MHRA ISSUE WARNING: SSRIs and SNRIs: Risk of persistent pulmonary hypertension in the newborn




Is this one of them moments where a patient can turn around to the MHRA and say, "I told you so."?

Much of my correspondence with the MHRA, indeed with their CEO, Kent Woods, regarding Seroxat being a teratogen is in my book, The Evidence, However, Is Clear...The Seroxat Scandal.

At the time of writing the book, the MHRA were fence sitting but this months safety update from the MHRA sees a crystal clear message.

They write:

Advice for healthcare professionals:

• Healthcare professionals, including midwives, should be aware of the increased risk of PPHN associated with all SSRIs and potentially with SNRIs. The observed increase in risk is about an extra 3–4 cases of PPHN per 1000 pregnancies.

• In light of these new data, healthcare professionals are encouraged to enquire about the use of these medicines, particularly in women in the later stages of pregnancy.

• Close observation of neonates exposed to SSRIs or SNRIs for signs of PPHN is recommended after birth.


There is still no mention of these drugs being teratogenic?

Regular readers of this blog will know that for some time I was liaising with the MHRA almost on a daily basis. The issue of whether Seroxat is a teratogen was the straw that broke the camels back and I refused to speak with them after receiving an answer [of sorts] from them regarding the Seroxat/Teratogen affair.

On the 5th of November, 2009 I sent an email to Sarah Morgan, Head of Pharmacovigilance Risk Management, at the MHRA. I also copied in Simon Gregor, Director of Communications at the MHRA. The question was short and sweet, Is paroxetine a teratogen?

Chapter 18 of my book highlights all the correspondence between myself and the MHRA. I'd even wrote to GlaxoSmithKline, the National Poisons Information Service [NPIS] and Yellow Card Centre Northern and Yorkshire Regional Drug and Therapeutics Centre. Between all four of them, not one could give me a straight answer.

The NPIS wrote:

"I am afraid we do not take enquiries from the public. If you are pregnant or thinking of becoming pregnant and are on paroxetine then talk to your GP or midwife who will advise you."


The Yellow Card Centre Northern and Yorkshire Regional Drug and Therapeutics Centre also fence sat with:

"Unfortunately here at the Yellow Card Centre Northern and Yorkshire we do not handle teratology enquiries. There is a dedicated teratology line for health professionals only listed in the BNF. Should you be a member of the public I suggest you make an appointment to discuss this with your GP."


GlaxoSmithKline refused to answer the question directly because I was not a health care professional. They wrote:

"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 patients with advice about medicines which are available on prescription because any advice we might give could conflict with that of your own doctor who is in a far better position to advise you. Therefore, to enable GSK to provide you with the most relevant information please can you confirm if you are a health care professional."


The MHRA wrote me [eventually].

The opening paragraph sets the tone for the three page answer!

"The question “Is paroxetine a teratogen?” is not as straight forward as it may appear."


The three page answer along with my replies to them and further correspondence with their CEO, Kent Woods is all in my book.

I still stand by my decision not to correspond with the MHRA any more.

The recent MHRA update kinda proves how fickle they are.

Fid

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'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
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