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.
Many prescription medications have been the subjects of lawsuits because of their adverse and often irreversible effect on patients. One of many prescription medications facing many lawsuits from their consumers is the prescription drug Reglan. Reglan, with the generic name metoclopramide, is a prescription medication primarily used to help with nausea and vomiting. Over the years, Reglan has been prescribed to control GERD (gastroesophageal reflux disease), heartburn and decreased appetite in both children and adults alike. Although there have been positive results from taking the medication, there has also been adverse side effects, one of which is tardive dyskinesia or TD.
Tardive dyskinesia is a severe and often permanent disorder that results in involuntary and repetitive body movements that begin slowly. Children or infants who have taken Reglan tend to have higher risks of developing tardive dyskinesia. Although approved by the FDA, they are only recommended to be taken as short-term treatment and when other methods were not effective. Reglan should only be taken between 4 to 12 weeks, but apparently many consumers have taken them longer than prescribed.
Studies have determined that as many as 1 in every 4 patients have very high risk of developing symptoms of tardive dyskinesia after taking Reglan for more than a year. And because Reglan can make it is often difficult to diagnose tardive dyskinesia since it conceals the symptoms, consumers tend to develop and display advance state of this condition. Presently, there is no cure for tardive dyskinesia, which makes it even more painful and hard to cope with.
Some of those who have developed this condition have already sought the help of a lawyer to help in fling a defective pharmaceutical lawsuit and seek compensation. Although there have been risks that come with taking Reglan and metoclopramide in general, nothing in the label have explained the dangers clearly. Because of this negligence, the manufacturer can be held liable, as with the case to those who have taken NuvaRing, a birth control pill that have caused serious blood clots and stroke in women. Just as what a NuvaRing lawyer would advice, consulting with lawyers who understand how medical malpractice and personal injury lawsuits work would play a huge part in ensuring that compensation will be given and that those who are responsible for the injury are made accountable for their actions.