An alert has been issued by the FDA indicating that Glaxo Smith Kline advises that results of research they have conducted indicate a significantly increased risk of severe birth defects in children born to mothers treated with paroxetine during the first three months of pregnancy.
This drug is marketed by GSK as Paxil and Paxil CR as treatment for depression. Since extremely early detection of pregnancy is notoriously difficult and unplanned pregnancies are common, it would seem logical to me to cease prescribing this drug to all females of child bearing age. However, that’s just my view.
I have previously indicated that I am generally against the use of pharmaceutical drugs. I consider very few of them to be worth the risks that unavoidably are associated with their use. I am especially critical of the majority of doctors who prescribe them far too readily. I recommend extreme caution with prescribing any drugs during pregnancy. Since the prescribers don’t seem to care, it becomes the responsibility of each individual to decide whether drugs are necessary or an alternative treatment would be wiser in the circumstances.
The text of the FDA information release is provided below.
Neuropsychiatric and other healthcare professionals
[Posted 09/27/2005] GlaxoSmithKline (GSK) and FDA notified healthcare professionals of changes to the Pregnancy/PRECAUTIONS section of the Prescribing Information for Paxil and Paxil CR Controlled-Release Tablets to describe the results of a GSK retrospective epidemiologic study of major congenital malformations in infants born to women taking antidepressants during the first trimester of pregnancy. This study suggested an increase in the risk of overall major congenital malformations for paroxetine as compared to other antidepressants [OR 2.2; 95% confidence interval, 1.34-3.63]. Healthcare professionals are advised to carefully weigh the potential risks and benefits of using paroxetine therapy in women during pregnancy and to discuss these findings as well as treatment alternatives with their patients.
I have said elsewhere that pharmaceutical companies use patients as part of their real world experiments. People, including many doctors, have been fooled into believing that high standards of safeguards exist that prevent dangerous drugs from being approved. How many more examples do people need, to see through the pharmaceutical lies?
One tragic irony in this situation is that the last thing a depressed mother needs is to have a child with severe birth defects due to drugs she was taking. The distress of the defects in the child and the potential for guilt are likely to impact negatively on the depression experienced by the mother. Will the executives or stock holders of GSK lose any sleep over this do you think?
Note that GSK’s Paroxetine is commonly marketed as Aropax 20 in Australia. My cautions and GSK’s information are of course relevant globally.
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Dr Peter Tylee
Editor