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What is Zofran and Why is This Drug So Controversial?
Experienced personal injury attorney Marc Whitehead discusses the drug Zofran, what makes this medication so controversial, and what your options are if you or your child have experienced harmful side effects due to its usage.
Whats Zofran?- The multi- million dollar pharmaceutical giant glaxosmithkline developed Zofran nearly 25 years ago to help cancer patients manage extreme nausea and vomiting in 2006 the US food and Drug administration approved generic drugs to Zofran. For reasons that are debated, Doctors began prescribing the drug for off label uses. "Off label" refers to the use of the drug for something other then what the drug was officially approved to treat.
The most prominent of these uses involved treating pregnant women who had extreme morning sickness. This extreme morning sickness typically presence early in the pregnancy and happens in about 1 of every 100 pregnancies and can cause severe risks to both the mother and the fetus. Doctors thought that Xofran could be useful to treat morning sickness for several reasons.
1- At the time physicians didn't have a go to drug to help pregnant women with this problem.
2- Xofran is technically known as a 5HT3 antagonist meaning it suppresses the release of an important neurotransmitter caller serotonin and at the same time forces the stomach to empty faster thereby reducing the likelihood of painful vomiting.
3- glaxosmithkline educated doctors to view the drug as a high effective and appropriate remedy to stop nauseous behavior in pregnant women.
What went wrong? There have been plenty of ugly facts that have emerged over time to challenge this particular pharmaceutical avenue for treating morning sickness.
1- The FDA never approve Xofran to be used by pregnant women
2- The safety data of this drug was pooled from just over 200 fetal records- a small sample size.
Think about that for a second- million of pregnant women and their fetuses have been subjected to this drug yet the safety data com. es from just over 200 fetuses. That is, by any measure, a staggeringly thin body of evidence.
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