Contact Us

*    Denotes required field.

   * First Name 

   * Last Name 

   * Email 


Cell Phone 

Street Address 

Zip Code 



Date you started taking this drug:

Date you stopped taking this drug:

Age of patient when antidepressant(s) prescribed:

What condition was this medication prescribed to treat?

What additional medications were you taking at the time?

Did patient hurt themselves during or after taking the drug?

Did patient become violent during or after taking the drug?

Was suicide attempted?

Was hospitalization or institutionalization required after taking antidepressant(s)?

Did loved one commit suicide?

If patient did attempt or commit suicide, did patient ever attempt suicide previously?

If patient did commit suicide, what was the method of suicide?

Please describe violent or suicidal behavior:

If you ever tried to stop taking Paxil and experienced withdrawal, please describe the withdrawal side effects:

Please further describe side effects:

For verification purposes, please answer the below question:

No Yes, I agree to the Parker Waichman LLP disclaimers. Click here to review.

Yes, I would like to receive the Parker Waichman LLP monthly newsletter, InjuryAlert.

please do not fill out the field below.

Paxil May Cause Birth Defects

Sep 28, 2005 |

GlaxoSmithKline (GSK) and the Food and Drug Administration (FDA) notified physicians yesterday that PAXIL and PAXIL CR (paroxetine HCI) may be linked to a higher rate of birth defects than currently found with similar drugs.

GSK recently conducted a retrospective study of congenital malformations in babies born to 3,581 women taking antidepressants during the first trimester of pregnancy.  Preliminary results suggested an increase in the risks of congenital malformations associated with the use of PAXIL as compared to other antidepressants.  The malformations were usually cardiovascular, with the most common being ventricular septal defects. 

In a letter to healthcare professionals, GlaxoSmithKline noted that the retrospective study was designed to evaluate the relative risk of congenital defects in infants born to women who were taking antidepressants.  The study did not include a comparison to infants who were not exposed to antidepressants.

The British drug maker noted that a number of previous studies relating to first trimester exposure to antidepressants have been done since the late 90’s, with various conclusions.  The mixed results make it difficult to definitively conclude that paroxetine has a causal relationship to any particular congenital abnormality.

PAXIL currently carries a Category C pregnancy precaution on its label.  The precaution indicates that that no well-controlled human studies have been done on the effect of taking paroxetine during pregnancy.  Information concerning the new study will be added to the label.

GSK cautioned doctors to “carefully weigh the potential risks and benefits of using paroxetine therapy in women during pregnancy.”  They encouraged doctors to discuss the latest findings with their patients.

Related articles Other articles
Parker Waichman Accolades And Reviews Best Lawyers Find Us On Avvo