Pro Publica has published a lengthy article exploring how the medical establishment’s long-standing approach to “protecting” fetuses by restricting testing on pregnant women has resulted in a critical shortfall of knowledge. While the intention was mostly good — to protect women and babies from the kind of severe birth defects and other harm caused by thalidomide and other drugs in the 1960s and ‘70s (but also to protect pharmaceutical companies from legal liability for those injuries) — the result is less certain. By excluding women — and pregnant women in particular — from clinical trials, doctors have been forced into prescribing untried medications “off-label” to pregnant women, with results that can lead to serious negative health consequences for mothers, and birth defects for babies. [Read more…]
As reported by Law360, the US Judicial Panel on Multidistrict Litigation has consolidated in Massachusetts a number of lawsuits alleging that off-label promotion by GlaxoSmithKline of its anti-nausea drug Zofran for morning sickness led to serious birth defects. “The MDL panel found that 12 lawsuits, some of which are proposed class actions, warranted consolidation as they all involved common allegations that GlaxoSmithKline’s Zofran and its generic equivalent, Ondansetron … cause birth birth defects in children when their mothers ingest the drug while pregnant.” [Read more…]
Parents charge that Zofran (generic name ondansetron) is a dangerous and defective drug because its use by pregnant women can lead to serious birth defects. Zofran was approved by the FDA in 1991 to treat extreme nausea from chemotherapy and later expanded for use as a treatment for serious surgical nausea. Lawsuits allege that the drug has been marketed off-label by GlaxoSmithKline to obstetricians and gynecologists to prescribe to their pregnant patients to control the pregnancy nausea commonly referred to as “morning sickness.”
Zofran has become a widely popular morning sickness treatment. Physician expectations were that the anti-nausea drug would benefit the patient, but GlaxoSmithKline, the manufacturer of Zofran, allegedly provided little information on the drug’s effect on unborn children. In numerous lawsuits, parents charge that GlaxoSmithKline failed to warn about an association between Zofran and certain very specific birth defects such as cleft palate and heart defects.