The data that links Zofran and birth defects keeps piling up. Lawsuits have been filed against the drug’s manufacturer, GlaxoSmithKline, because they failed to warn pregnant women that the drug can cause injuries to their unborn children when taken during pregnancy.
What is Zofran and what does it do?
Zofran is an excellent nausea drug that was originally approved for use in individuals who were undergoing surgery or chemotherapy. The nausea associated with these surgeries is unbearable, and Zofran does a wonderful job of helping people deal with the pain.
But the organizations that make drugs like Zofran are corporations, and what do corporations like to rake in? Profits. So naturally, GlaxoSmithKline tried to figure out other ways to increase their market share for Zofran. One of the ways it did this was to push the drug “off label” on pregnant women suffering from morning sickness. Given the effectiveness of the drug in fighting nausea, this seemed like a good idea. However, the FDA did not and has not approved the drug for such usage, which comes as no surprise given the threat of birth defects to unborn children of mothers on the drug.
Purposefully pushing a drug on those who might be injured by it for the sole purpose of raking in cash seems like a corporate conspiracy theory, right? But the fact that the government levied a $3,000,000,000 (that’s three billion) fine against GlaxoSmithKline for fraud, failing to report safety data, and peddling drugs “off label” supports the claim.
What kind of damage does the drug cause?
Zofran taken during the first trimester of pregnancy has been linked to various birth defects including: cleft lips, cleft palates, and now heart defects. A recent Swedish study now shows that there is a significant correlation between heart malformations and Zofran taken during pregnancy. Specifically, the study looked at infants born between 1998 and 2012, and determined that those who were exposed to Zofran were 62% more likely to experience heart problems, with that group being twice as likely to experience septum defects. These defects were serious and included atrial septal defects (ASD) and ventricular septal defects (VSD). The study did come to a conclusion that GlaxoSmithKline probably does not want to hear: Zofran should not be proscribed to pregnant women because the drug is unsafe for their unborn children.
It is not like this study is an outlier or anomaly either. Studies in 2012 and 2013 showed that children born to mothers who were proscribed Zofran were twice as likely to experience defects. Another 2013 study said that the risk of defects could increase as much as four times for an unborn child.
Lawsuits against GlaxoSmithKline alleging birth defects are grounded in the claim that the corporation knew about these defects, yet failed to properly inform women about them in the name of corporate greed. At minimum, women should have been given a choice between other drugs. Remember, Zofran was not approved by the FDA for this type of use, plus the federal government levied a massive fine against Glaxo, meaning the government is not too high on the drug or its manufacturer.
If you think your child was harmed by Zofran while they were in the womb, we can help. Taking on the big boys requires skill and resources, both of which we have. Call us at 800-553-8082 or visit our website for a free online consultation.