FDA Asks Pfizer for Update to Zoloft Label, Warns of Birth Defect Risks

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Bloomberg reports that the FDA asked Pfizer in August “to modify safety warnings for its antidepressant Zoloft (sertraline) and acknowledge for the first time that some studies linked the mood-altering medication to heart defects in newborns.” According to the Bloomberg report, “Pfizer is fighting lawsuits by hundreds of women who say they weren’t adequately warned the drug could cause defects in their newborns.” “While some legal experts say the label change could help the company fend off future lawsuits, it could also help bolster claims by those who have already sued over Zoloft, once the most prescribed antidepressant in the U.S.”

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5 COMMENTS

  1. Think about it for a minute “birth defects” one of the most horrible things that happens to parents and kids and this article and Pfizer are all about sales and lawsuit strategies. Shows how much they care.

    In all of human history women managed to have babies without Zoloft and did just fine.

  2. I was one of the first guinea pigs on this evil drug, looked in a big book at the pharmacy, where I couldnt pick up my script, as it wasnt even passed for use in Australia, when my damn psychatrist gave me the freebies from his cupboard……. Anyhow, yes I fell pregnant unexpectedly, gave up the drugs the zoloft within 8-10 weeks………… too late, the damn big pharma book, said no problems noted in pregnancy, only later I learnt this was pharma speak for NEVER EVER TESTED FOR USE IN PREGNANCY> RIP lovely Steven, born seemingly healthy, dead in agony, three days later. Yes half a heart HLHS…………… 19 years now, I been trying to get TGA to get the report right, still they seem unable to…………………………………. I cant sue, I live in Australia, no one, has helped me for 19 damn years…….. I feel so guilty, I should have tried harder, so many more disabled and dead babies, in those 19 years…………………………..

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