Trenton, NJWhen weighing the risks and benefits of a drug such as Zoloft, patients generally consider how effective Zoloft is against the risk of Zoloft side effects, which may include a risk of Zoloft birth defects. Those risks may be seen to be low, considering the drug is treating a condition as serious as depression.
A lawsuit filed against Pfizer, however, alleges that Zoloft is no more effective at treating depression than a sugar pill. According to USA Today (1/31/13), the plaintiff, Laura A. Plumlee, alleges she took Zoloft for three years but Zoloft did not effectively treat her depression. Pfizer, according to the lawsuit, committed consumer fraud and paid physicians to include their names as authors of studies that were allegedly written by Pfizer.
Pfizer has responded to the lawsuit by calling it frivolous and noting that studies have shown Zoloft is effective at treating depression. But a lawyer for the plaintiff argues some clinical studies have shown Zoloft to not be effective.
The lawsuit seeks class-action status and requests a refund for all costs incurred by California residents who purchased Zoloft.
The issue for expectant mothers is whether the risks of Zoloft side effects are worth the benefits. Not only do the mothers face a risk, but their unborn babies could also be affected by exposure to Zoloft. Among potential side effects for infants are birth defects such as persistent pulmonary hypertension of the newborn and other congenital defects. Zoloft is classed in FDA Pregnancy Category C, meaning animal studies suggest fetal harm but studies have not been conducted in humans.
Lawsuits have been filed against Pfizer, maker of Zoloft, alleging the drug is linked to birth defects in infants. The Louisiana Record (2/13/13) reports on one lawsuit, filed by Leslie Kemmerer Hezeau, who filed a lawsuit alleging her use of Zoloft was responsible for her child being born with hearing problems. The lawsuit (case no 2:13-cv-00108) accuses Pfizer of failing to warn consumers about the risks.
Zoloft is in a class of drugs known as selective serotonin reuptake inhibitors (SSRIs). It is an antidepressant used to treat depression, obsessive-compulsive disorder and post-traumatic stress disorder.
In December 2012, the FDA approved a label change for Zoloft, warning about the risk of serotonin toxicity. The updated label notes that patients who are being treated with MAOI medications should not be put on Zoloft because of the risk of serotonin syndrome, a potentially life-threatening condition. Serotonin syndrome has been reported in other SSRI medications, especially when used with other serotonergic drugs, the FDA noted.
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