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Paxil has been the target of controversy, with a suit filed in June 2004 by New York Attorney General Eliot Spitzer alleging Paxil manufacturer GlaxoSmithKline engaged in repeated and persistent fraud by concealing and failing to disclose to physicians critical information about Paxil''s safety and efficacy to its use in the pediatric population. In August 2004, the consumer activist group SSRI Citizen launched its national awareness campaign, announcing antidepressants are “Unsafe at Any Dose”. The use of popular antidepressants like Paxil and pregnancy has also been the source of debate in the absence of any controlled trials being done with pregnant woman taking Paxil.
Studies show that 10 to 20 percent of pregnant women experience depression and many women struggle to determine if Paxil and pregnancy is a riskier than enduring the depression. Depression can cause pregnancy complications by causing the mother to alienate themselves from their families, interfere with the mother''s ability to bond with the baby and can have harmful effects on the unborn baby. Obstetricians also face challenges when acknowledging Paxil and pregnancy since antidepressant medication is outside of their expertise.
Especially for women with severe depression, possible Paxil and pregnancy risks may outweigh the effects of the depression. Many obstetricians and mothers still wonder why there are no guidelines indicating what risks may include so that they can decide alongside their doctors if Paxil and pregnancy is something that is worth the possible effects. Many women continue to take Paxil while pregnant since they do not have the information necessary to make the decision not to.
There is some safety data from studies looking at Paxil and pregnancy outcomes after the fact, but still an actual controlled study is yet to be performed. The majority of concern with Paxil and pregnancy is for the exposure mothers have very late in pregnancy. Documentation of studies and case reports has shown subtle, abnormal changes to the nervous systems of exposed newborns and there is no information available showing if these effects are toxic long-term of the drugs or symptomatic of withdrawal.
In Canada, the health department issued an advisory in August 2004, warning that drugs including Paxil and pregnancy may be putting babies at risk when used during late pregnancies. International and Canadian reports indicate some newborns developed complications at birth requiring prolonged hospitalization, breathing support and tube feeding when Paxil and pregnancy, as well as other newer antidepressants were used. Some reported symptoms in the Paxil and pregnancy babies included, feeding and/or breathing difficulties, seizures, muscle rigidity, jitters and constant crying, with most cases involving mothers using the antidepressants during the final three months of pregnancy.
Women that are also breastfeeding and using Paxil are not sure how that might affect their baby. Paxil passes through into the breast milk, and generally, it has been believed to be safe to breast feed taking antidepressants, though a lack of controlled studies is also missing from this area of concern. Many doctors and women would like to see the effect of Paxil and pregnancy compared to the effects of depression and pregnancy on babies so that informed individual decisions can be made.
A woman living in Canada filed a defective drug lawsuit against Glaxo Smith Kline, the distributor of Paxil, a drug prescribed to treat depression. According to the lawsuit, Shannon Cote, 29, was prescribed » Read More
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Use of the anti-depressant drug Paxil during pregnancy has been linked to a very serious birth defect in infants - PPHN<...
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