Like many popular name-brand pharmaceutical drugs, Zofran has delivered on its promises for relief and improved the health of patients. Zofran has been marketed by GlaxoSmithKline primarily as a nausea treatment drug for cancer patients. The relief from nausea may not seem like a big treatment, but for those receiving chemotherapy on a regular basis, the freedom from nausea is a step toward restoring normalcy. The success of drugs like these has resulted from years of word-of-mouth recommendations by doctors and peers alike, as well as the unavailability of many viable alternatives. Without more options, Zofran and other name-brand prescription drugs become household names, which can then usually translate into brand trust.
Once the public begins to trust a household prescription drug like Zofran, for example, is it any wonder that concerns about off-label uses do not raise the level of attention seen during the initial approval process? In other words, the FDA approval process is rigorous. Yet, after the FDA approval, doctors may begin prescribing these drugs for off-label uses. The public then begins to associate the drugs for these off-label, or unapproved, uses.
Perhaps you are pregnant and anticipating the arrival of your little bundle of joy; perhaps you just welcomed your new baby into this world at Decatur Morgan Hospital; or perhaps you are taking Zofran for a non-pregnancy-related issue and are concerned about possible future side effects for when the day comes that you do decide to have a baby. Whatever the situation, you need answers on this potent drug. You deserve a happy life in Decatur, Alabama and elsewhere in Morgan County—one safe from the ills of pharmaceutical companies. Contact a Decatur, AL, products liability attorney immediately with any questions you may have. At Martinson & Beason, P.C., we are here to help you.
Potential Dangers of Off-Label Use Prescriptions Drugs
One very famous (or infamous) example of off-label prescription was the prescription cocktail known as Fen-Phen. Originally intended as two separate drugs used for the short-term treatment of obesity, doctors began prescribing the combination as off-label general weight loss pills. The results of the dramatic weight-loss from both drugs used in tandem was offset by serious and debilitating heart valve injuries. So many patients have been damaged by the combination of Fen-Phen that a multi-billion-dollar class action lawsuit was filed and finally resulted in having the two drugs pulled from circulation.
Zofran was originally manufactured to decrease nausea following radiation treatment. However, cancer patients are not the only market for this type of relief. Many pregnant mothers suffer from agonizing nausea, some to the point of requiring hospitalization. Some women develop a severe form of nausea called Hyperemesis Gravidarum (HG). According the non-profit organization, Hyperemesis Education and Research (HER) Foundation, HG is “generally described as unrelenting, excessive pregnancy-related nausea and/or vomiting that prevents adequate intake of food and fluids.” HG is a serious ailment that affects both the mother and the unborn fetus—which may be born with defects.
Mothers cannot take any medication while struggling to cope with the extreme nausea and vomiting of HG, or vomiting during pregnancy in general. While Zofran does not uniformly create negative side effects for every woman taking it, sufficient evidence exists showing the correlation between birth defects and taking the drug. Some pregnant women may find themselves asking whether the risks of taking Zofran outweigh the benefits. Since every woman experiences the nausea and possible other reactions to pregnancy differently, speaking with a medical professional to weigh these options makes the most sense. Notwithstanding the risks, Zofran may be the only viable option for some pregnant women who cannot gain relief by any other method. For more questions, please don’t hesitate to reach out to a Decatur, Alabama, products liability attorney.
Birth Defects and Zofran
The challenge during pregnancy for any woman is deciding what to ingest and what to allow in terms of environmental exposures. From allergy medications, to beverages, to lunch menus—even whether to apply sun tan lotion or chemical hair dyes—a pregnant woman makes many large and small choices throughout her pregnancy. When her body rejects even fluid or the safest of food choices, however, the difficulty then becomes how to maintain equilibrium with vital bodily functions. Hydration and nutrition become the absolute essentials to experiencing a normal balance. Because nausea prevents appetite and vomiting prevents hydration and nutrition, the threats to the still developing fetus can take their toll very quickly. A threat to the mother’s health translates to a threat to her child.
The trouble with using Zofran for an off-label use such as preventing or balancing hormones during pregnancy is that the medication can help the mother but can harm the baby. Some possible birth defects that can result from taking Zofran during pregnancy are:
- Ventricular septal defect (VSD)
- Tetralogy of fallot (TOF)
- Cleft lip/cleft palate
- Transposition of the great arteries
- Limb defects
- And more
Some studies suggest that the mother is also at risk from taking the medication during the pregnancy. Even where the harm is not immediately obvious to either mother or child, the benefit given to the mother would be immediate. Most medical professionals and parents-to-be clearly stand on the side of preventing birth defects, so being able to avoid heart defects and other birth defects in a newborn child is the optimal goal.
Legal and Medical Options
Where Zofran becomes a medical option, the mother’s health and the child’s long-term viability seem to be at odds. The question then shifts to one of utility and benefit to the mother’s health versus maintaining some long-term safety to the child’s health. Those questioning why the FDA has not pulled Zofran from the marketplace entirely should remember that the drug continues to hold clear and consistent benefits in the treatment of nausea in non-childbearing cancer patients.
Some of the legal problems lie with the manufacturers of Zofran, GlaxoSmithKline, having promoted the drug specifically for its off-label use. The drug maker was sued by the U.S. government for these practices, resulting in multi-billion dollar settlement. However, the drug’s popularity and public perception of the drug as a viable option may not have been sufficiently altered by the lawsuit. The result is that prescribing doctors may warn about Zofran’s risks, but pregnant women may feel they have no alternative, are willing to accept the risk, or are insufficiently aware of the drug’s inherent dangers.
If you or a loved one believe that Zofran may have caused birth defects, please reach out to speak to a products liability lawyer in Decatur, Alabama. You may have legal options. These types of cases are heavily based on fact and medical analysis, as well as existing medical studies, so it makes sense to work with a legal professional. Please reach out to the experienced and compassionate staff and attorneys of Martinson & Beason, P.C. to speak more about your options.