Generic Paxil Suicide Lawsuit

Citizens Commission on Human Rights Award Recipient (Twice)
Humanist, humorist

Sunday, April 29, 2012

Neonatal Abstinence Syndrome

Although the newborns featured in this video are mainly suffering from neonatal abstinence syndrome (NAS) as a result of their mothers taking pain medication during their pregnancies, there is an alarming number of babies that suffer the same when their mother's take SSRi medication throughout their pregnancy.

This has been admitted by GSK with regard to Paxil...but they didn't make a song and dance about it.

One would have thought an advertising campaign on national TV or full page newspaper spreads would have been the order of the day, alas, GSK much prefer to post their warnings on their website. One can only find it if one knows what they are looking for.

This from GSK's webpage:

Levinson-Castiel et al found a 30% (18/60) rate of neonatal abstinence syndrome (NAS) [45% severe and 55% mild] in a large population-based study that included infants with a reported prolonged in-utero exposure to SSRIs.(53) Of these neonates 62% (37/60) were exposed to paroxetine at a dose range of 10-40 mg.

To get some sort of idea what paroxetine withdrawal in newborns may look the video from CNN.

Neonatal abstinence syndrome is just one of many conditions SSRi can cause in newborns. The British drug regulator, the MHRA, and their American counterparts, the FDA, are in a position to put a stop to babies [like the ones featured in this video] being born with these conditions. By simply stating SSRi use is not recommended in pregnancy is clearly not good enough... they should be banning the use instead of touting the pathetic benefit v risk line. 

I'm left wondering if CEO officials at the MHRA and FDA would place a knife in a crib in the knowledge that there was only a 30% chance that the newborn may roll on to it or if they would leave a candle burning in a child's room if there was a 10% chance of it setting fire to nearby curtains?

A limp-wristed approach will only result in further babies suffering. Putting the onus on doctor's is simply a deflection to avoid personal responsibility.

The regulators are playing with fire.

If you were in a position of power to stop the above, would you?

In 2009 GlaxoSmithKline were found guilty by a verdict of 10 to 2 in a Paxil birth defect trial. The jury found that Paxil, an antidepressant manufactured by GlaxoSmithKline, was the causation of Lyam Kilker being born with heart defects. It was a landmark ruling and a further 800 cases were pending. It is believed that most, if not all of those 800 cases have been settled out-of-court by GlaxoSmithKline, settlements that omitted that GlaxoSmithKline were in any way responsible for the 800 or so babies being born with birth defects.

Evidence produced in the Kilker trial showed that Glaxo officials knew very early on that Paxil could cause birth defects because of its teratogenic effects.

The UK regulator, the MHRA, were sent all court transcripts from the Kilker trial.

They decided not to investigate GlaxoSmithKline.

The MHRA's Head of Licensing, Ian Hudson, was a former employee of GlaxoSmithKline [then SmithKline Beecham], in fact he was the global head of clinical safety. One would have thought the MHRA could have used his knowledge about the dangers of taking Paxil during pregnancy. He's mentioned in the following deposition by Jane Nieman, another former employee of GSK.

The MHRA's proud mission statement on their website reads:

We enhance and safeguard the health of the public by ensuring that medicines and medical devices work and are acceptably safe.

Do newborn babies fall under this apparent safeguard?

Other birth defects caused by SSRi use include:

Abdominal Birth Defects / Omphalocele
Autism Spectrum Disorders
Anal atresia (complete or partial closure of the anus)
Cardiac (heart) defects
Cleft lip and cleft palate
Clubfoot (one or both feet turn downward and inward)
Craniosynostosis (skull defect)
Limb Defects
Neural-tube defects (brain and spinal cord, spina bifida)
PPHN (Persistent Pulmonary Hypertension of the Newborn)

For more information visit the Antidepressant & Birth Defects Website HERE




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