New Caution on Using Paxil During Pregnancy (Dec. 2005)

GlaxoSmithKline has notified healthcare professionals that new precautionary information is being added to the labeling for the antidepressant Paxil (paroxetine hydrochloride).

The new information summarizes a retrospective epidemiologic study performed by the company. This study suggests that the risk of major congenital malformations in infants born to women who take Paxil during the first trimester may be approximately twice as high as the risk for women taking other antidepressants.

The company is recommending that physicians carefully weigh the potential risks and benefits of using Paxil during pregnancy, and that they discuss these latest findings, along with treatment alternatives, with their patients.

Additional Information:

FDA MedWatch Safety Alert - Paxil (paroxetine) and Paxil HCl CR Controlled Release Tablets.
http://www.fda.gov/medwatch/safety/2005/safety05.htm#Paxil2

FDA MedWatch Safety Alert - Paroxetine HCl - Paxil and Generic Paroxetine.
http://www.fda.gov/medwatch/SAFETY/2005/safety05.htm#Paxil3

Category:

News & Politics

Tags:

• Paxil
• Pregnancy
• FDA
• Patient
• Safety
• Congenital
• Malformations
• Antidepressant
• Depression