Glaxo adds birth defect caution to Paxil label

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Tue, 27 Sep 2005 17:21:29 -0400

[sSRI-Research] Glaxo adds birth defect caution to Paxil label

 

 

 

Glaxo adds birth defect caution to Paxil label

 

http://news./s/nm/20050927/hl_nm/glaxosmithkline_paxil_dc

20 minutes ago

 

GlaxoSmithKline Plc is alerting physicians about a study suggesting

the company's antidepressant Paxil may be more likely to be linked to

birth defects than similar drugs, U.S. regulators said on Tuesday.

 

The company, in a letter posted on the Food and Drug Administration

Web site, said it was adding the information to the prescribing

instructions on Paxil's label. Glaxo added that it was difficult to

tell if Paxil caused the defects, most of which were cardiovascular,

in infants born to women who took the drug while pregnant.

 

" Preliminary results suggest an increase in the risk of congenital

malformations associated with the use of (Paxil) as compared to other

antidepressants, " the company's letter to physicians said.

 

" The preliminary results of this study and recent abstracts ... differ

from previous epidemiologic studies, making it difficult to conclude

whether a causal relationship exists, " it said.

 

Physicians should " carefully weigh the potential risks and benefits of

using paroxetine (Paxil) therapy in women during pregnancy and ...

discuss these findings as well as treatment alternatives with their

patients, " the FDA said.

 

The letter is available online at

http://www.fda.gov/medwatch/safety/2005/safety05.htm#Paxil2

 

 

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