Warnings on Zoloft Birth Defects Softened by FDA

In recent allegations made during Zoloft Lawsuits, plaintiffs have said they took Zoloft because they believed it to be a safe medication for women to ingest while pregnant. Instead, their babies were born with Zoloft Side Effects such as heart defects, neural tube defects, gastroschisis, omphalocele, craniosynostosis, cleft lip, club foot, anal atresia and limb reduction defects, but now the FDA has indicated that conflicting studies make it premature to reach any conclusions. On December 14, the FDA issued a selective serotonin reuptake inhibitor (SSRI) drug safety communication, indicating that the drug labels will be updated for the entire class of medications, which includes Zoloft. The FDA will update warning labels about the potential link between SSRI antidepressants and PPHN to reflect the new data and conflicting results.

Recent studies had found that women who took Zoloft during pregnancy were more likely to give birth to babies experiencing Zoloft birth defects than women who take other antidepressants or women who do not take any antidepressants during pregnancy. These Zoloft side effects can be life-threatening and include serious health problems such as Zoloft heart defects. Now, many women are investigating filing their own Zoloft lawsuit, alleging the company did not properly warn them about the risks associated with taking the antidepressant during pregnancy. The FDA told doctors that they must weigh for themselves the potential risks and benefits of prescribing an antidepressant from the SSRI family to a pregnant mother, noting that untreated depression can also lead to poor birth outcomes.

More recently, momentum has been building for Zoloft lawsuits over Pfizer’s failure to warn about the risk of birth defects when taken during pregnancy. Plaintiffs have asserted that Pfizer knew or should have known that Zoloft crosses the placenta, which could have important implications for the developing fetus. The complaints accused Pfizer of knowing of the dangers but failing to inform the public. In fact, plaintiffs have alleged that Pfizer marketed Zoloft as the safest anti-depressant on the market for expectant mothers. plaintiffs allege strict products liability, breach of express warranty, negligence, misrepresentation by omission, negligent misrepresentation, fraud and misrepresentation, fraud by concealment, violation of consumer protection laws and breach of implied warranties against Pfizer.