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According to a recent investigative report by the non-profit news organization ProPublica, the vast majority of drugs are never tested to determine what impact they may have on unborn children when taken during pregnancy.
Due to concerns over the risks associated with exposing unborn children to new medications, the report indicates that 95% of clinical drug trials exclude pregnant women. However, an estimated 90% of women use some prescription drug during pregnancy, potentially exposing children to risks that were never examined or studied.
ProPublica points to the recent concerns about a link between the anti-nausea drug Zofran and birth defects to highlight how avoiding studies that examine potential drug pregnancy risks causes many women and doctors to assume medications on the market are safe to take during pregnancy.
Although Zofran is only approved for treatment of nausea and vomiting among chemotherapy and surgery patients, a large portion of the drug sales in recent years have been to pregnant women experiencing morning sickness. However, a number of recent studies have now suggested that exposure to the drug during the first trimester of pregnancy may increase the risk of children suffering congenital heart defects, as well as oral cleft problems, such as cleft palate or lip.
The recent studies that have uncovered the Zofran pregnancy risks all involved post-marketing data after the drugs had been sold for years, meaning that they looked at the effects on unborn babies by examining what effects Zofran had in the real world. Essentially, the ProPublica report suggests that pregnancy drug testing is happening anyway, but involving unaware participants.
GlaxoSmithKline now faces hundreds of Zofran birth defect lawsuits brought by families nationwide, alleging that the drug maker had access to data and information that suggested the medication may pose an unreasonably risk for pregnant women, yet failed to follow up on that data or warn women and the medical community. The pharmaceutical company previously paid $3 billion to resolve claims that it illegally marketed Zofran and other drugs by giving doctors kickbacks and promoting them for users that were never approved by the FDA.
The ProPublica report highlights concerns about how to strike a balance between protecting pregnant mothers from clinical trials of drugs that may be dangerous to them and their fetuses, while finding a way to make sure that the drugs are safe for pregnant women before they hit the market.
According to the CDC, regulators are unsure whether 90% of drugs currently on the market are safe for pregnant women. Many of them are prescribed to women off-label, potentially making them and their unborn children uninformed test subjects.
As part of a continuing effort to address the problem, the FDA is expected to release draft guidance for the pharmaceutical industry later this year on the scientific and ethical considerations of including pregnant women in clinical trials.