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Sunday, August 19, 2007

SEROXAT Patient Information Leaflet Updated


The following 'rant' contains adult language. Do not read if easily offended


Well it seems the time has come for GSK to update the patient information leaflet regarding Seroxat. They, I believe, are still in denial that is causes suicidal thoughts in adults, despite overwhelming evidence to the contrary.

A patient information leaflet is the slip of paper the patient uses as a guide when opening his medicine.

Here are some extracts from the updated Seroxat patient information leaflet.

Tell me if your average patient can understand this:

4.3 Contraindications

Paroxetine is contraindicated in combination with monoamine oxidase inhibitors (MAOIs). Treatment with paroxetine can be initiated:

- two weeks after discontinuation of an irreversible MAOI, or

- at least 24hrs after discontinuation of a reversible MAOI (e.g. moclobemide).

Paroxetine should not be used in combination with thioridazine because, as with other drugs which inhibit the hepatic enzyme CYP450 2D6, paroxetine can elevate plasma levels of thioridazine (see Section 4.5, Interactions with other medicinal products and other forms of interaction). Administration of thioridazine alone can lead to QTc interval prolongation with associated serious ventricular arrhythmia such as torsades de pointes, and sudden death.

Crystal clear eh?

Skimming through it I notice there is now no mention of a chemical imbalance - something that was touted around to market Seroxat in the first place!!! Why have they dropped this now? Is it because it was complete and utter bollocks in the first place?

Oooh, and look 'electric shock sensations' - WOW! GSK acknowledging the yellow card reports it seems!

I find the Children and adolescents (7-17 years) section quite sickening - they knew this years ago - to include it on a patient information leaflet now is like telling a child they will burn their hand if they put it in the fire... after they already fucking have!

Paroxetine should not be used for the treatment of children and adolescents as controlled clinical trials have found paroxetine to be associated with increased risk for suicidal behaviour and hostility. In addition, in these trials efficacy has not been adequately demonstrated (see section 4.4 Special warnings and special precautions for use and section 4.8 Undesirable effects).

GSK still however fail to attach special warnings to pregnant mothers. Terminology such as 'Paroxetine should only be used during pregnancy when strictly indicated.' is simply NOT GOOD ENOUGH!

And talk about passing the buck:

The prescribing physician will need to weigh the option of alternative treatments in women who are pregnant or are planning to become pregnant.


How about something like 'Seroxat should NEVER be given to pregnant mothers'

Now, I can bet you the MHRA's slapdash enquiry into GSK will use this updated patient information leaflet and make comment such as - 'GSK have done everything to correct their mistakes... blah blah fucking blah'

I'm angry - can you tell?

Rant over