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No Smoke without Fire – Prescription Drugs tied to Birth Defects

Posted on Feb 14, 2015 by in Pharmaceuticals | 0 comments

Drug company GlaxoSmithKline paid $1 billion in fines to the Department of Justice (DoJ) to settle charge of fraudulent marketing of some of its most popular products, including anti-emetic agent Zofran (ondansetron). It has also agreed to put up a $2 billion fund to settle civil lawsuits. Other drugs included in the charges are Paxil (paroxetine, an antidepressant), Wellbutrin (bupropion, also an antidepressant), and Avandia (rosiglitazone, an anti-diabetic). It seems that GSK makes a practice of promoting off-label uses for its products, not content with the income generated from approved uses.

The US is not the only country that has slapped GSK with fines for one violation or another. China has most recently fined GSK $489 million for bribing doctors, hospitals, medical associations, and public officials to help them raise drug prices. The UK government is currently investigating fraud allegations against GSK in other countries, including Poland, Lebanon, and Iraq.

Zofran was not particularly singled out in these investigations, but it continues to be a source of concern for physicians and their pregnant patients. Off-label use of Zofran was considered acceptable for women suffering from serious nausea and vomiting or pregnancy (NVP), also known as morning sickness, because earlier studies indicated no reason to suspect fetal danger. However, recent studies with larger populations indicate that there is a 30% increase in the risk of a birth defect when Zofran is administered before the 10th week of pregnancy.

Part of the charges brought by the DoJ against GSK was for failing to report safety data and concerns about its drugs. Women were prescribed with Zofran in their first trimester because their doctors believed it was safe. Of these women, those whose children had birth defects such as club feet, heart defects, cleft lift or palate, or abnormally shaped skull (craniosynostosis) may be eligible for compensation, according to the website of Williams Kherkher. Contact a Zofran attorney in your area for more information about filing a personal injury lawsuit.

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