Pfizer considering request by FDA to change Zoloft warnings

09/25/2015 // JusticeNewsFlash // (press release)

Washington – The U.S. Food and Drug Administration has requested that Pfizer change its product safety warnings for the antidepressant drug Zoloft. Bloomberg Business reported that the company was considering the request, which, according to a statement emailed by Pfizer, was made in August as part of the FDA’s effort to reformat drug labels throughout the U.S.

Pfizer is quoted as stating “The new language, which is still in draft form, reflects the extensive science supporting the safety and efficacy of Zoloft, stating a complete review of the scientific evidence finds that there is no difference in birth defect risks between pregnant women who took Zoloft and those who did not.”

Several lawsuits have been filed against the drug manufacturer by women who claim they did not receive adequate warning that the drug could cause birth defects.

Some legal experts suggest that although changing the product label to include warnings about these risks could help the company in defense against future legal claims, it may provide more support for those that have already been filed.

Erik Gordon, a law professor at the University of Michigan, is quoted in the report as stating of the issue “Since the FDA is basically forcing them to acknowledge the existence of credible studies showing Zoloft may cause heart defects, a jury could conclude they were ignoring or hiding those links to sell more of their product.”

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