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Please
contact us with any questions or if you'd like to explore your legal rights
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Paxil
Paxil (Paroxetine HCI) and Paxil CR (controlled release) are manufactured by GlaxoSmithKline. Paxil is an antidepressant prescribed for major depressive disorder, social anxiety disorder, generalized anxiety and post-traumatic stress. Paxil CR is indicated for major depressive social anxiety, premenstrual dysphoria, and panic disorders.
On September 27, 2005 Medwatch, the FDA's safety information and adverse event reporting system, and GlaxoSmithKline, the manufacturer of Paxil and Paxil CR, warned healthcare professionals of changes to the Pregnancy Precaution section of the Prescribing Information for the drugs. This warning came as a result of the GSK's recent epidemiologic study of major congenital malformations in infants born to women taking the antidepressants during the first trimester of pregnancy.
On December 8, 2005, the FDA issued a statement that exposure to Paxil in the first trimester of pregnancy may increase the risk for congenital malformations, particularly cardiac malformations. GSK, at the FDA's suggestion, changed the label to warn of these malformations. The FDA also indicated that physicians should encourage discontinuation of Paxil in pregnant patients.
Motley Rice LLC is currently litigating individual cases in which Paxil users have infants who were exposed to Paxil within the first trimester with the following injuries or symptoms:
- Congenital Malformations
- Cardiovascular Malformations
- Severe withdrawal symptoms related to late stage pregnancy exposure
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If you have any questions regarding Paxil, please contact Lynn Seithel at 843 216 9134.
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