Although its risks are just beginning to be fully understood, many women who have received Zofran are looking for birth defect lawyer assistance after their child experienced serious health problems. The popular anti-nausea drug, known by its trade name ondansetron, is considered an extremely important medication for a country to have, even making the World Health Organization’s List of Essential Medications. It is one of the most effective antiemetics available to people undergoing surgery or chemotherapy, but it has only been approved by the FDA for these uses. This is the heart of the concern with the drug, because it has a history of being given to pregnant women for morning sickness, even though this is an off-label treatment.
WHY ARE SO MANY WOMEN WHO RECEIVED ZOFRAN SEARCHING FOR A BIRTH DEFECT LAWYER?
Prescribing medications for off-label use is always dangerous because the research isn’t there to determine whether or not it is a safe course of action. The FDA does not encourage off-label use of medications, but it hasn’t stepped in to prevent ondansetron from being given to pregnant women. This is likely because the medication has been placed in Pregnancy Category B after some animal studies did not find a high risk of complications in animal fetuses. However, this doesn’t necessarily mean that the drug is safe, because human biochemistry is different, and some complications go undetected even after initial rounds of research.
In fact, ondansetron is the subject of conflicting research, demonstrating just how important it is to test a medication carefully before bringing it to market. While one Danish study that followed 600,000 patients detected no increased risk of complications, a second Danish study, which incorporated nearly 1 million patients, determined that some heart abnormalities were twice as common in children who were exposed to the medication during development. What’s alarming about this finding is that women tend to take ondansetron during the first trimester, when the child is going through accelerated development. These results were confirmed by CDC and the National Center on Birth Defects and Developmental Disabilities.
WHAT SIDE EFFECTS ARE ASSOCIATED WITH ZOFRAN?
A birth defect lawyer regularly helps families that have been affected by heart complications. Ondansetron is another medication associated with them, specifically septal heart complications. Septal heart complications represent severe physical abnormalities, and usually manifest as poorly developed ventricular walls. This makes it more difficult for the heart to pump blood and also exposes the child to even more serious health concerns. Septal heart complications can make severe cardiac events much more likely and can cause arrhythmias that last the child’s entire life. As a result, the child will have to be monitored and treated with care, as even something as simple as vigorous exercise can provoke an event.
In the coming months, hundreds of cases will likely make their way into courts around the country. Because GlaxoSmithKline did not test its medication properly and pushed doctors into prescribing it to pregnant women, it will likely face heavy litigation from all sides.