Conflicting Study Results Provide no Answers
Clinical trials are supposed to be carried out for any kind of drug before they are sold to the public to determine if they are safe for use, not after. They are also designed to identify certain classes of people or conditions which will be adversely affected by it. This is true for over-the-counter medication and prescription drugs, and it is the responsibility of the drug manufacturer to carry them out. In most cases, the Food and Drug Administration (FDA) will require these trials prior to approval for use for specific conditions.
In the case of the anti-emetic drug Zofran (ondansetron) produced and marketed by GlaxoSmithKline (GSK), the drug company carried out clinical trials that showed it was highly effective for suppressing nausea associated with chemotherapy, radiation therapy, and post surgery. However, the clinical trials presumably did not go far enough, because recent studies show that it could increase the risk of developing heart arrhythmia. And that isn’t even the biggest problem. The problem is with its off-label use to treat severe nausea and vomiting of pregnancy (NVP). Zofran has been associated with causing birth defects.
Studies were undertaken to prove it one way or the other. The results, however, are maddeningly vague. There are “indications” or “failed to find” results that instead of clearing up the matter for the public, merely muddy up the waters. According to Williams Kherkher’s website about the Zofran lawsuit, it falls on affected patients to come forward and tell their stories in order to gather evidence that will prove the drug does cause birth defects.
GSK has already been made to pay for encouraging the drug’s use for NVP although it was not approved for that purpose by the FDA. However, because GSK insists that Zofran is safe for pregnant women and studies show conflicting results, women continue to be prescribed with the drug for NVP.
If you have been prescribed with Zofran for NVP, and you child had birth defects, you may be able to help. Contact a Zofran lawyer in your area to add your voice to women who have been similarly harmed.