Zoloft Lawsuit News: FDA Asks Pfizer To Add Birth Defect Warnings On Its Zoloft Drug Label


Wright & Schulte LLC Represents Clients In Zoloft Lawsuit Filings Contending Pfizer Inc. Failed To Warn About The Potential Of Birth Defects In Newborns Whose Mothers Took The Antidepressant During Pregnancy.

Zoloft-Lawsuits-SSRI-Antidepressants-Lawsuit-Birth-Defect-Side-EffectsAs Zoloft lawsuit claims continue litigation, the U.S. Food and Drug Administration (FDA) has asked Pfizer Inc. to change it’s warning label. The new Zoloft safety label should include that Zoloft studies indicate taking the antidepressant drug during pregnancy may increase the risk of birth defects in newborns. Zoloft’s current safety label says there are “no adequate and well-controlled studies” regarding the medicine’s effect on pregnant women, according to a Bloomberg Business report. Zoloft birth defects lawsuits filed against Pfizer accuses the company of failing to adequately warn about possible birth defects from Zoloft use during pregnancy.

Pfizer told Bloomberg that the FDA made its request in August as part of the agency’s initiative to improve the content and format of prescription drug labeling. In 2005, Zoloft earned $3.3 billion in sales, making it the “best-selling antidepressant on the market.” However, the company lost Zoloft’s patent protection in 2006 and generic versions of Zoloft are produced by other drug manufacturers. The generic versions must also contain the same warnings as those on Pfizer’s Zoloft safety label.
[bloomberg.com/news/articles/2015-09-17/pfizer-weighing-fda-request-to-change-zoloft-s-warnings, Bloomberg Business, September 17, 2015]

“It’s important that doctors and their patients have this information before prescription drugs, such as Zoloft, are prescribed to expectant mothers,” explains Wright & Schulte, LLC, a nationwide law firm representing women in Zoloft birth defects lawsuits.

Zoloft (sertraline) is in a class of psychotropic drugs called Selective Serotonin Reuptake Inhibitors (SSRI), which are used as antidepressants to treat anxiety disorder, obsessive compulsive disorder, and post-traumatic stress disorder. Zoloft was approved by the FDA in 1999. In 2006, the FDA issued a warning about SSRI drugs after reviewing a case-control study published in the New England Journal of Medicine that found infants born to mothers who took SSRIs after their 20th week of pregnancy were six times more likely to have persistent pulmonary hypertension than infants born to mothers who did not take antidepressants during pregnancy.
[fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm126522.htm, July 2006]
[nejm.org/doi/full/10.1056/NEJMoa052744, February 6, 2006]

In December 2014, the FDA published a new rule that set standards for providing information on how using medication during pregnancy and breastfeeding is presented on the labels of prescription drugs and biological products. The new standard requires three detailed subsections on the labeling titled, “Pregnancy,” “Lactation,” and “Females and Males of Reproductive Potential.” The subsections must include a summary of the risks of using a drug during pregnancy and breastfeeding, a discussion of the data supporting the summary, and relevant information to help health care providers make prescribing and counseling decisions.
[fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm425317.htm, FDA, December 3, 2014]

Court documents indicate that 278 Zoloft birth defects lawsuits are pending in the U.S. District Court, Eastern District of Pennsylvania, where Judge Cynthia Rufe is presiding over the multidistrict litigation. The Zoloft birth defects lawsuits allege the antidepressant causes children to be born with atrial septal defect, pulmonary hypertension, lung defects, carniofacial defects and other congenital malformations. Judge Rufe recently scheduled the first Zoloft bellwether trial in March 2016 for a case involving an Alabama woman who alleges that her son was born in January 2008 with congenital birth defects due to her prescribed use of Zoloft during pregnancy. The baby was born with complex congenital heart disease, ventricular septal defects, right ventricular hypoplasia and other health complications. The complaint says the child underwent multiple corrective surgeries and needs ongoing medical treatment and care. (Case No. 2:12-cv-02595, In Re: Zoloft (Sertraline Hydrochloride) Products Liability Litigation – MDL No. 2342)

About Wright & Schulte LLC and Filing A Zofran Lawsuit Claim: Wright & Schulte LLC, an experienced personal injury firm, is dedicated to the belief that America’s legal system should work for the people. Every day, the attorneys of Wright Schulte LLC stand up for the rights of people who have been injured or wronged, and fight tirelessly to ensure that even the world’s most powerful corporations take responsibility for their actions. If you’re looking for a law firm that will guarantee the aggressive and personal representation you deserve, please do not hesitate to contact Wright & Schulte LLC today. Free Zoloft lawsuit evaluations are available through yourlegalhelp.com, or call 1-800-399-0795.

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