Update 1: Glaxo's Paxil Linked to Birth Defects

[struggle4progress]

09.27.2005, 05:55 PM

GlaxoSmithKline PLC warned doctors that its Paxil drug may be more closely linked to birth defects than other antidepressants, according to a letter published Tuesday on the Food and Drug Administration Web site.

The company said preliminary results from a retrospective analysis of women taking antidepressants during the first trimester of pregnancy found more birth defects associated with Paxil than other medications. The infants' birth defects were typical of those in the general population, with the most common being holes in the walls that separate the heart's ventricles.

GlaxoSmithKline noted that the results conflict with another study and said it is changing the drug's label to reflect data from both trials. The new label still states that there are not adequate and well-controlled studies in pregnant women. <snip>

http://www.forbes.com/technology/ebusiness/feeds/ap/2005/09/27/ap2247729.html

[politicat]

1. The patient data sheets say that these drugs should not be taken by

pregnant or lactating women. (And the idea of getting pregnant while depressed is not a good idea to begin with....)

It may just be a statistical blip, but....

[electron_blue]

2. virtually every med in the U.S. says it should not be taken by pg

women, that being on the label is meaningless by itself.

Not that it matters to the discussion here, but many women who take paxil while pg go onto the drug after finding out they are pg.

I've already heard this about Paxil being correlated with hole in the heart defects. Is this really all that new????

[loudsue]

3. There are so many women I know in the 20-25 age bracket that

are on Paxil, and CAN'T GET OFF!! It's a nasty drug, anyway you look at it. Glaxo sure knew what they were doing when they got this one approved, didn't they? Nobody can get off it without going nuts.

:kick: