Glaxo adds birth defect caution to Paxil label

"Glaxo adds birth defect caution to Paxil label", Reuters UK, September
27, 2005,
Link:
http://today.reuters.co.uk/news/news...E-PAXIL-DC.XML

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/2...y05.htm#Paxil2