FDA Advisories and Safety Alerts
July 19, 2006
Treatment Challenges of Depression in Pregnancy
July 19, 2006
Combined Use of 5-Hydroxytryptamine Receptor Agonists (Triptans),
Selective Serotonin Reuptake Inhibitors (SSRIs) or Selective
Serotonin / Norepinephrine Reuptake Inhibitors (SNRIs)
May Result in Life-threatening Serotonin Syndrome
December, 2005
Increase in the Risk of Birth Defects
December, 2005
Increase in the Risk of Congenital Malformations
December 8, 2005
Safety Alert for Paxil and generic paroxetine (Paroxetine HCI)
December 8, 2005
FDA Advising of Risk of Birth Defects with Paxil
Agency Requiring Updated Product Labeling
GlaxoSmithKline Healthcare Professional Advisories
December, 2005
Revision of the Pregnancy Precaution from Pregnancy Category C to Pregnancy Category D
Indicative of Positive Evidence of Human Fetal Risk
September 29, 2005
Findings Suggest Increased Risk Over Other Antidepressants, of
Congenital Malformations, Following First Trimester Exposure to Paroxetine
September, 2005
Changes in the Pregnancy Subsection of the Precautions Section in the Labels
for Paxil (paroxetine HCL) and Paxil CR (paroxetine HCL) Controlled-Release Tablets
Health Organization Advisories
July 12, 2006
Alliance for Human Research Protection
Harvard / Stanford--Psychiatry's Opinion Leaders Financial Ties to Industry
March, 2006
NeuralPsychiatry Reviews
Risks Associated with Antidepressant Use During Pregnancy
February 9, 2006
Alliance for Human Research Protection
Safety of Newborn infants Threatened by Rx Antidepressants During Pregnancy
December 12, 2005
American Society of Health-System Pharmacists
Paroxetine Ups Risk of Birth Defects
September 28, 2005
American Society of Health-System Pharmacists
Safety of Paroxetine During Early Pregnancy Questioned
August 9, 2004
Health Canada
Health Canada Advises of Potential Adverse Effects
of SSRIs and Other Anti-depressants on Newborns