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As the number of Zofran lawsuits grows, plaintiffs question why doctors aren’t prevented from prescribing drugs off-label. Continue reading
prREACH
Dec 04, 2015 /prREACH/ -- The number of lawsuits filed against the drug manufacturer GlaxoSmithKline has grown steadily over the last two years, each one alleging that the anti-emetic drug Zofran caused a birth defect in an unborn child. Each lawsuit also alleges that GSK unlawfully marketed the drug off-label to doctors around the country. Recently, plaintiffs have begun to question why doctors were able to prescribe the drug off-label to expectant mothers.
When a drug is prescribed off-label, it means that a doctor has recommended the drug to treat a condition or disease that the FDA did not approve the drug for. The FDA gives its approval for very good reason - either they have performed clinical trials that show the drug isn’t safe for a group of patients or there haven’t been enough studies to prove how safe the drug is. The approval process isn’t a simple one - companies first have to present pre-clinical trials which may include animal testing, pass three phases of human clinical trials under FDA supervision, and submit the appropriate paperwork. The hope is that this process will keep patients safe.
But there is nothing to prevent doctors from prescribing drugs to patients whose conditions were not included in the FDA's approval. In many instances, the doctor isn’t even aware that the drug is being used off-label, just that others have had success using it for specific conditions.
Plaintiffs who have filed a complaint regarding Zofran often state that if they and their doctors had been aware of the risks associated with using the drug during pregnancy, they would never have taken it, and their child would not have been harmed. While many don’t blame their physicians, they do question why the doctor wasn’t aware of the conditions the FDA did or didn’t approve Zofran for.
Zofran has been on the market since the early 90’s and has been prescribed to countless women to treat morning sickness during pregnancy. However, this wasn’t what the drug was approved for. The FDA approval indicated that the drug was safe for patients experiencing nausea and vomiting after radiation, chemotherapy, and anesthesia. The FDA never indicated that the drug was safe for pregnant women and their unborn children.
Today, GSK is facing lawsuits filed by parents that believe Zofran caused a birth defect in their child. The complaints include birth defects such as ventricular septal defect, atrial septal defect, transposition of the greater vessels, clubfoot, respiratory distress syndrome, cleft lip, cleft palate, and kidney defects. In addition to seeking compensation for their medical expenses and more, plaintiffs hope that they can bring public awareness to the risks associated with the off-label use of drugs.