Effexor Birth Defects Lawsuit

Preliminary analysis from two unpublished studies has indicated that use of Effexor during the first trimester of pregnancy is linked to an increased risk of certain types of birth defects. In light of this information, our attorneys investigated the following types of injuries in infants born to women taking Effexor during pregnancy:

• Club foot
• Cleft lip and cleft palate
• Gastroschisis and omphalocele (intestine protrude out of the body)
• Enlarged heart
• Septal heart defects
• Patent Ductus Arteriosis (PDA)
• Narrow aorta
• Tetralogy of Fallot (ToF)
• Transposition of the great arteries
• Hypoplastic left heart syndrome
• Valve problems
• Craniosynostosis (skull deformity)
• Macrocephaly (abdominal large head)
• Neural tube defects
• Spina bifida
• Anal atresia
• Limb defects
• Other heart, skull and abdominal defects

The FDA has established a pregnancy category system to classify the potential risks to an unborn child when a certain drug is taken during pregnancy. The FDA has named Effexor aPregnancy Category C drug, meaning that it could potentially harm a fetus, particularly when used during the third trimester.

By placing Effexor into Category C, the FDA is warning that while the drug has not been tested in humans, animal studies have shown that it presents a risk to a fetus. Pregnancy C category drugs, like Effexor, can still be administered during pregnancy if the doctor believes that its potential benefits outweigh its risks to the child. The label advises that that woman tell their doctors if they become pregnant or intend on becoming pregnant during treatment.

In 2004, the label for Effexor was updated to advise patients that infants who were exposed to the drug during the third trimester had developed complications which warranted tube feeding, prolonged hospitalization and respiratory support. According to the FDA, these complications developed immediately after the birth.

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