Whether your pregnancy was a happy surprise or planned, you may have been elated to hear that you were going to have a child. Then, morning sickness kicked in, and you felt miserable. You experienced much more than a bit of nausea and occasional vomiting. Instead, you could hardly keep anything down and may not even have been able to function, let alone work, run errands or otherwise enjoy your pregnancy.
You doctor prescribed Zofran for you, and for the first time, you felt relief so you kept taking the drug. After all, if your doctor prescribed it knowing that you were pregnant, it must okay. Then, at some point, you found out that your baby suffered from a dangerous birth defect. You should know that you aren’t alone.
Zofran wasn’t developed for morning sickness
Ondansetron is the generic name for Zofran. Its manufacturer originally developed the medication for cancer patients to help them with the side effects of chemotherapy. At some point, doctors began prescribing it for morning sickness. The problem is that the Food and Drug Administration never approved the medication for use in this manner. No testing occurred to determine what side effects (such as birth defects) the drug would have on pregnant women and their unborn children.
The maker of the drug, GlaxoSmithKline, denies that Zofran causes birth defects, and the company claims that the research backs up this claim. However, the number of women coming forward saying that it does begs to differ. The research may lack the appropriate data since no one really wants to test drugs on a pregnant woman.
Did you know the drug wasn’t approved for morning sickness?
The distinct possibility exists that many women do not even know that the FDA never approved Zofran for morning sickness. You may be among the women who may not have taken the drug if you had known that undoubtedly important piece of information.
Due to the lack of testing, most drugs prescribed to pregnant women have not been through clinical trials and the other rigorous testing required for approval. Again, researchers hesitate to conduct these trials on pregnant women. In fact, only a handful of medications receive FDA approval, but Zofran was not one of them.
You have rights
An increasing number of lawsuits have been filed against GlaxoSmithKline regarding the “off-label” use of Zofran for morning sickness because their babies were born with congenital heart conditions and other birth defects. If this happened to you, you may benefit from scheduling a consultation with a compassionate and experienced Hawaii attorney who has no problem taking on big pharmaceutical companies.