A new study out of the Journal of the American Medical Association has shed some light on a longtime concern of the FDA that taking prescription drugs for uses unapproved by the regulatory agency may do more harm than good. In fact, researchers from McGill University in Montreal, Harvard Medical School, and...
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GlaxoSmithKline Slapped with Product Liability Lawsuit over Paxil
When Kathryn Kiker’s child was born with heart defects in 2001, she had no idea that Paxil, the antidepressant she was taking during her pregnancy, was likely contributing to her baby’s health problems. Paxil’s manufacturer GlaxoSmithKline (“GSK”) now faces a product liability lawsuit alleging fraud, citing that “At the time Paxil was prescribed to...
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Alabama Family Claims Zofran (ondansetron) Caused Heart Defects
Joining over 50 existing cases, another lawsuit has been filed alleging anti-nausea drug Zofran (ondansetron) was responsible for causing birth defects. The complaint contends that GlaxoSmithKline (“GSK”) marketed Zofran (ondansetron) “off label,” even though it was only approved for use by the FDA for treatment of severe nausea and vomiting in cancer patients or...
Ineffective Self-Regulation in the European Pharmaceutical Industry
The European health system of voluntary self-regulation in the pharmaceutical industry is being called into question by the findings of a study, published in the medical journal PLOS Medicine in February 2015, which revealed that European drug makers are regularly violating marketing practice codes. Data from 2004-2012 found that major pharmaceutical...
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