The new guidelines for treating nausea and vomiting during pregnancy published by the expert’s states that Zofran should be the last option to treat morning sickness. The Board of the Society of Obstetricians and Gynecologists of Canada approved the updated clinical practice guidelines which were reviewed by many experts from various organizations. Dr. Kim Campbell, the guidelines’ principal author and a registered midwife states that Women should be counseled to eat whatever pregnancy-safe food appeals to them and lifestyle changes should be liberally encouraged. As per the doctor’s advice the use of medicine should be avoided during pregnancy however morning sickness is curable without medicine. Doctor’s recommendation for curing morning sickness is discontinuing iron-containing prenatal vitamins.
The FDA approved Zofran in 1991 as a drug to treat nausea and vomiting, but only in patients who have undergone chemotherapy or radiotherapy, or who are experiencing nausea after surgery. The medication has never been approved for the treatment of morning sickness in pregnant women. Although Zofran has never been approved for this purpose, GSK began marketing the drug for morning sickness soon after it hit the U.S. market in 1991. There are several U.S families who are suffering from the severe Birth defect cause by Zofran. In 2012, the U.S. Justice Department announced that GlaxoSmithKline had crossed the line. It is illegal for physician to prescribe an off label medication for unapproved uses.
In 2012, GlaxoSmithKline has been fined $3billion in criminal and civil penalties to settle Department of Justice allegations that the company had promoted Zofran for off-label use in pregnant women and had bribed physicians and encouraging the prescription of unsuitable antidepressants to children. It also alleged that GlaxoSmithKline was paying kickbacks to doctors who prescribed Zofran. Women who take the medication during pregnancy gave birth to babies with birth defects, including cleft palates and lips, club foot, heart defects and Skull deformities – a condition in which the skull is abnormally shaped and may not have enough space for the brain. The birth defect from Zofran has reaction on the overall physical and mental health of the child.
GlaxoSmithKline not only marketed Zofran as a safe way to treat morning sickness, but the company also falsified animal studies on the drug, stating that it was safe despite the results showing that it can cause unusual bone growth and toxic illness. Zofran has been assigned to “Pregnancy Category B” by the FDA, which means animal studies failed to demonstrate a risk to the fetus and there were no adequate and well-controlled studies in pregnant women at the time it was approved. The physicians are advised by Medical practice guidelines to use caution when prescribing Zofran for the treatment of morning sickness. The physicians suggest that the drug should be used only after all other options for treating morning sickness have been exhausted.
As of now more than 400 Zofran lawsuits are pending in the U.S. District Court; District of Massachusetts alleging Zofran medication during Pregnancy to treat morning sickness can lead to newborns having cleft palate, cardiac malformations and kidney malfunctions. The lawsuits are being consolidated in the U.S. District Court of Massachusetts. The Plaintiffs alleges that manufacturer failed to determine safety risks before selling Zofran and did not have safety concern before offering the drug to the public. If you or someone you love has been injured by using Zofran medication, contact the Zofran lawsuit lawyers at Drugsclaim.com to schedule a free initial consultation.
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