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Drug labeling rule not much help to Zoloft victims


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A new federal rule will go into effect June 30 that is designed to help health care providers to make the risk vs. benefit analysis consistent with prescribing medications for use during pregnancy and lactation. Maybe this measure would have helped a lot of women had it been implemented sooner. For, while reform is on the way, lawsuits are being filed by women nationwide who claim that their use of the antidepressant Zoloft (sertraline) during pregnancy is linked to their children’s birth defects.

The regulation, which the U.S. Food and Drug Administration unveiled in December 2014, is known as the Pregnancy and Lactation Labeling Rule. The rule ideally will make pregnancy and lactation information more clear-cut on drug labels.

An FDA synopsis of the change reads, “[T]he final rule requires that the labeling include a summary of the risks of using a drug during pregnancy and lactation, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy and lactation. … The labeling must also contain relevant information, if it is available, to help health care providers make prescribing decisions and counsel women about the use of the drug during pregnancy; this could include information on disease-associated maternal and/or embryo/fetal risk, dose adjustments during pregnancy and the postpartum period, maternal adverse reactions, fetal/neonatal adverse reactions, and/or the effect of the drug on labor or delivery.”

Moreover, the rule perhaps will tell health care professionals and patients whether there is information available from a pregnancy exposure registry concerning the prenatal risks of the drug. A pregnancy exposure registry is a study that collects health information from women who use a medication during pregnancy and during the lactation period. Their experiences are compared to those of women who did not use the drug at those times.

Under the new rule as of June 30, the FDA writes, “If there is a pregnancy exposure registry for the drug, the telephone number or other information needed to enroll in the registry or to obtain information about the registry must be included at the beginning of the ‘Pregnancy’ subsection of labeling.”

Ironically, in the face of Zoloft lawsuits filed across the nation, the FDA lists no pregnancy exposure registry for Zoloft, a Pfizer drug. Maybe there ought to be.

A federal panel of judges centralized more than 500 pending federal Zoloft lawsuits before one court, in this case U.S. District Court for the Eastern District of Pennsylvania. When the panel made that decision in 2012, it wrote, “These actions share factual questions arising out of allegations that Zoloft causes birth defects in children whose mothers ingest the drug while pregnant.”

These birth defects claims are validated by science, including a Canadian study that the American Journal of Obstetrics and Gynecology published. The authors of the study found, “Sertraline use during the first trimester of pregnancy was associated with an increased risk of atrial/ventricular defects and craniosynostosis above and beyond the effect of maternal depression.”

Women who used Zoloft during pregnancy and who had children with birth defects have a choice. They can silently accept their circumstances or they can hold the manufacturer accountable for the irreparable harm allegedly linked to its product.

If you are in this number, please consider doing what other victims have done: Contact one of the Zoloft attorneys at Reich & Binstock for a free case evaluation. Reich & Binstock has been practicing pharmaceutical product liability law since 1984. Its attorneys have a laudable track record in fighting for justice on behalf of victims of drugs with serious side effects, and they have experience that Zoloft victims surely will want on their side.

Contact Reich & Binstock either by calling the toll-free number, 1-866-LAW-2400, or by submitting an electronic message through this web page.

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