A study from earlier this year by M. Reis and B. Källén showed that paroxetine [brand names, Seroxat, Paxil and Aropax] seems to be associated with a specific teratogenic property.
The study was carried out because of concerns about possible adverse effects of the use of antidepressant medication during pregnancy, including risk for neonatal pathology and the presence of congenital malformations.
This particular study, entitled, "Delivery outcome after maternal use of antidepressant drugs in pregnancy: an update using Swedish data", was published in the Cambridge University Press early 2010.
Data from the Swedish Medical Birth Register (MBR) from 1 July 1995 up to 2007 were used to identify women who reported the use of antidepressants in early pregnancy or were prescribed antidepressants during pregnancy by antenatal care: a total of 14,821 women with 15,017 infants.
The conclusion?
"Women using antidepressants during pregnancy and their newborns have increased pathology. It is not clear how much of this is due to drug use or underlying pathology. Use of TCAs was found to carry a higher risk than other antidepressants and paroxetine seems to be associated with a specific teratogenic property."
Not so much of a conclusion really as it can be argued that is not clear how much of this is due to drug use or underlying pathology - this is the basis of arguments used in court rooms or 'negotiating tables' with GlaxoSmithKline's lawyers across the US.
The majority of Paxil birth defect cases have been settled out of court, the odd one or two have been lost by the claimants on legal technicalities.
The Reis/Källén study is quite significant in as much that it fingers GSK's Paxil as not only being associated with a specific teratogenic property, it also shows that pregnant patients taking Paxil increase the chances of their babies being born with cardiovascular defects and hypospadias.
What is hypospadias?
Hypospadias is a congenital (present at birth) problem affecting a boy’s penis. It is a combination of three separate problems: the hole through which urine passes (meatus) is not at the tip of the penis, the foreskin is gathered at the back of the penis with none at the front and the penis may be bent when stiff. The position of the meatus varies; in some boys, the hole is only a small distance away from the tip of the penis, whereas in others, it is at the base of the penis, in the scrotum or behind the scrotum. [1]
According to the Great Ormond Street Hospital for Children NHS Trust website, about one in every 300 boys has hypospadias, although this figure seems to be rising. It is not known why this figure is rising. So we have that grey area of whether or not paroxetine increases the chances of a male child being born with hypospadias. The Reis/Källén study seems to suggest that it does.
Who is responsible?
So, the question, who is responsible falls into the pot. Do we point the finger of blame at the manufacturer of Paxil, GlaxoSmithKline or do we scrutinise the body who regulate and license drugs in the UK, namely, the MHRA?
Even if blame is placed upon either of these two, who, or more importantly, whom is responsible? What individual should take the blame for allowing a known teratogen to be prescribed to pregnant patients?
Surely, whomever it is, should be in a position to answer questions from concerned members of the public, moreover, consumers of a product.
The CEO of GlaxoSmithKline is Andrew Witty. Should Witty go public and offer an explanation as to why a drug manufactured by the company that he heads could increase the chances of heart and hypospadias malformations? It's one thing adding a warning to the ever increasing [in text] patient information leaflet [PIL] - but is this really enough? In any event, would this really be advisable considering GlaxoSmithKline are settling and defending many hundreds of Paxil birth defect trials in America?
Or do we expect more from the MHRA's CEO, Kent Woods?
The MHRA's role is to protect the public from unsafe drugs. With paroxetine top of their adverse reactions list, they could argue that they are doing enough.
The MHRA, like Glaxo, have half heartedly warned people of the risks of taking paroxetine whilst pregnant. What they haven't done is label it a teratogen. One would have thought that lessons were learned for the most infamous teratogen of them all, Thalidomide, a drug that was mainly prescribed to pregnant women for morning sickness in the late 50s and early 60s. Instead the drug caused severe deformities in babies with missing limbs.
Are we on the brink of Déjà Vu here?
There is a fine line of protecting patients with regard to paroxetine use. The MHRA tout the risk/benefit ratio and they, apparently, would not want to alarm the public over paroxetine's propensity to cause malformations because they are [still] of the opinion that the benefits of taking paroxetine outweigh the risks.
The Reis/Källén study would suggest otherwise.
Wise up - pull the drug.
The study is available for download [for a fee] HERE
[1] What is hypospadias?
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'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
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