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Lawsuits: Morning Sickness Drug Zofran Causes Birth Defects

By Christopher Coble, Esq. | Last updated on

Morning sickness is an unpleasant and unfortunate side effect of pregnancy. And expectant mothers, doctors, and drug manufacturers have long been searched for a cure for pregnancy-related nausea. The trouble is finding a remedy that won't have an adverse effect on the fetus.

GlaxoSmithKline thought they had stumbled upon an answer with Zofran, a drug originally used to combat nausea in cancer patients undergoing chemotherapy. But a new series of lawsuits claims Zofran causes birth defects, and that GlaxoSmithKline never cleared it for use on pregnant women.

FDA Approval

When drugs are approved by the Food and Drug Administration, they are normally approved for a particular purpose. In the case of Zofran (also marketed as Zuplenz or its generic ondansetron), FDA approval was for preventing nausea and vomiting in cancer patients undergoing chemotherapy, but only as a Category B pregnancy drug. Category B means it was tested safely on pregnant animals, but not on humans.

Doctors are allowed to prescribe drugs for "off-label" uses, but drug companies are prohibited from pushing drugs for uses that haven't been approved by the FDA. Recent lawsuits are accusing GSK of "using expectant mothers and their unborn children as human guinea pigs" in order to test the effects of Zofran. And some of those effects have been catastrophic, including congenital heart, orofacial, and septal defects as well as kidney malformation and even stillbirths.

GSK Liability

GlaxoSmithKline already pleaded guilty and agreed to pay $3 billion as the result of a Department of Justice investigation into the company's unlawful promotion of Zofran and other prescription drugs. GSK was allegedly pushing doctors to prescribe Zofran to pregnant women, even though the FDA ordered GlaxoSmithKline to "immediately cease distribution" of ads that "promote Zofran in a manner that is false or misleading because it lacks fair balance" as far back as 1999.

But that previous settlement allegedly doesn't cover severe birth defects from Zofran use, and there were almost 200 lawsuits filed against GSK over Zofran birth defects last year alone. Most, if not all, of those suits are being consolidated into one case against the drug company.

If you used Zofran to treat morning sickness and your child was born with birth defects, you may be entitled to compensation. You should consult with an experienced personal injury attorney about your case -- most are happy to review your claim for free.

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