AMA Urges Paroxetine Users To Consult Their Doctors

7 Sep 2005

The AMA is today alerting its members of a decision by pharmaceutical company, GlaxoSmithKline (GSK), to strengthen its warning against the use of Paroxetine for the treatment of depression in women contemplating pregnancy or in the first trimester of pregnancy.

The AMA advises patients not to worry and to seek immediate advice from their doctor.

A national response to inform patients has been prepared by the Therapeutic Goods Administration (TGA).

The decision comes after a Danish study and an unpublished US study both indicate an increased risk of cardiovascular defects in children born to women taking Paroxetine.

Paroxetine is classified as a Selective Serotonin Reuptake Inhibitors (SSRI).

The TGA advises that in Australia Paroxetine is registered under the trade names Aropax, Oxetine, Paxtine, Chem mart, GenRx and Terry White Chemists Paroxetine, Paroxetine-RL, Paroxetine-BC, Paroxetine Hexal, Espar, Loxamine, Paroxat CR, and Ausrox.

The identified problem is ventricular septal defects, which can occur also in non-SSRI users. It is a common, benign malformation that mostly resolves itself and may not even be diagnosed.

Authorities in the US and Australia stress that the problem is confined to Paroxetine and is not generalised to all SSRIs.

The GSK decision affects women on Paroxetine who are contemplating pregnancy, or who are in their first trimester of pregnancy.

It is important that women do not suddenly stop taking their Paroxetine. They must contact their doctor - GP, psychiatrist or obstetrician/gynaecologist - as soon as possible to seek advice about stopping their medication safely.

7 September 2005

CONTACT: John Flannery (02) 6270 5477 / (0419) 494 761

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