Physicians Still Able To Prescribe Drugs Off-Label Despite Pending LitigationWhile Zofran litigation moves forward, many question why doctors are still able to prescribe the drug off-label to expectant mothers. Despite the growing number of lawsuits filed against GlaxoSmithKline, each alleging that the drug Zofran caused a birth defect in an unborn child, doctors are still prescribing the drug off-label to expectant mothers to treat morning sickness.
Off-Label Use Of DrugsThe U.S. Food and Drug Administration has an extensive approval process for drugs. The company who wishes to gain FDA approval first presents preclinical trial data which includes any testing performed on animals and information on how they would choose to proceed with human testing. Then, clinical trials are performed where the drug is administered to healthy volunteers. This is known as Phase 1. During this phase the drug’s side effects are noted.
If the drug makes it through Phase 1, Phase 2 begins. This phase helps researchers to determine if the drug will work for patients with a specific type of disease or condition. Phase 3 follows soon after which allows the drug to be administered to larger groups of people, in different dosages, and in combination with other drugs.
After Phase 3 the company may file a New Drug Application which will be reviewed.
If the drug is approved, the FDA will note the type of patients that it believes the drug is safe for on the label. This, however, does not prevent doctors from prescribing the drug off-label. This means that the drug will be administered to patients whose diseases or conditions fall outside of the FDA approval. There are no laws or regulations that prevent doctors from doing this, and in many instances, the doctor isn’t even aware that they are prescribing the drug off-label.
Off-Label Use Of ZofranZofran received its FDA approval in 1991. The drug was approved for the treatment of nausea and vomiting in patients after chemotherapy, radiation, and anesthesia. The drug was never approved for the treatment for morning sickness in pregnant women.
GSK, the makers of Zofran, marketed the drug off-label to physicians around the country. The drug soon became one of the most popular anti-emetics used to treat morning sickness. However, soon after they began their marketing campaign, the company allegedly began receiving reports from OB/Gyns who noted birth defects in children born to women who had taken the drug during their pregnancy.
The Birth DefectsIn the past two years, numerous parents have filed lawsuits, each one alleging that a child was born with a birth defect because the mother took Zofran. Birth defects claimed in the lawsuits include kidney defects, clubfoot, atrial septal defect, ventricular septal defect, transposition of the greater vessels, respiratory stress disorder, cleft lip, and cleft palate. In most cases the child has needed corrective surgery to fix their defect.
In almost every complaint, the mother has stated that if she had known about the risks associated with the drug, and the fact that her doctor was prescribing it off-label, she never would have taken it.