Safety Alerts & Recalls

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Untreated depression or other mood disorders can also place a pregnancy at risk for complications. If you are a woman taking fluoxetine and become pregnant, do not stop taking your medicine without first speaking with your doctor. Please discuss the risks and benefits of continuing this medicine during pregnancy with both your doctor and obstetrician.

If you are taking fluoxetine or one of the other fluoxetine-containing products and are thinking about becoming pregnant, please discuss your plans with your doctor so that together you can decide on the best and safest treatment of your condition while you are pregnant.

MHRA Drug Safety Update Discusses Fluoxetine Use During Pregnancy

In the March 2010 Drug Safety Update, the Medicines and Healthcare products Regulatory Agency (MHRA) reports that recent studies suggest a possible increased risk of heart related birth defects in infants of mothers who used fluoxetine (brand leader Prozac) in early pregnancy. This increased risk was similar to the increased risk of heart related birth defects seen with paroxetine (brand leader Seroxat). At this time, there is not enough information to draw conclusions on whether there is a similar risk for other antidepressant medicines.

Fluoxetine is a medicine used for the treatment of depression, as well as other conditions including bulimia and obsessive-compulsive disorder (OCD). Other common names for fluoxetine include Oxactin, Ranflutin, Prozep, Prozac, and Prozit.

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Source: MHRA
Publication Date: 2010-04-05
Last Updated: 2010-11-08

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