ZofranLegal.com has reported that many of the plaintiffs in the ongoing litigation have claimed that GlaxoSmithKline should have performed clinical studies prior to marketing Zofran to expectant mothers. Many have also suggested that the drug should have been submitted a second time to the FDA, for approval of the use of the drug as a treatment for morning sickness.
The process of applying for the U.S. Food and Drug Administration’s approval of a drug is not a simple one. First, the drug which has been developed is tested on animals. Multiple species are tested for toxicity levels and adverse reactions. This data is then given to the FDA for review.
If the FDA approves the drug for further testing, Phase 1 of the clinical trials begins. Healthy volunteers are given the drug and are carefully monitored. This phase’s purpose is to determine what the side effects are and how frequently they occur. Researchers also determine how quickly the drug is metabolized.
Phase 2 begins when the drug is administered to people with a specific condition or disease. The short term side effects are studied. During this process, the FDA and developers of the drug discuss how Phase 3 will work. During Phase 3, the drug is administered to at least a thousand people in different dosages and in combination with other drugs. At the end of this phase, the research is submitted once again to the FDA. The department may then deny approval, suggest that further clinical trials be run, or approve the drug.
However, just because a drug has been approved by the FDA, doesn’t mean it is safe for everyone to take. In fact, many drugs which are safe for adults are dangerous when given to pregnant mothers. If the drug transfers from the mother to the baby, it may disrupt the baby's development and cause a birth defect.
GSK, the manufacturers of Zofran, went through this process when they submitted the drug for approval, however, they did not include pregnant women in their clinical trials. When the FDA approved the drug, the department indicated that it was safe for patients undergoing procedures involving chemotherapy, radiation, or anesthesia. The approval did not extend to expectant mothers.
The company still decided to proceed with a campaign which recommended that doctors prescribe the drug as a treatment for morning sickness, a condition frequently diagnosed in women during the first trimester of their pregnancy. Their advertising was so well done that Zofran soon became one of the most frequently prescribed drugs by OB/GYN’s.
Today, hundreds of parents have filed lawsuits against GSK, alleging that Zofran caused a birth defect in an unborn child. Birth defects listed in the complaints include atrial septal defect, ventricular septal defect, transposition of the greater vessels, cleft lip, cleft palate, kidney defects, and respiratory distress syndrome. The plaintiffs all claim that GSK should never have marketed the drug as a treatment for morning sickness without the approval of the FDA.
For more information about the ongoing litigation, contact Michael Monheit at (877) 620-8411.
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Contact ZofranLegal.com:
Michael Monheit
1-877-620-8411
michael@monheit.com
1368 Barrowdale Road, Rydal, PA 19046
