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Why Were Pregnant Women Prescribed Zofran?
Research shows that 70% to 90% of expecting mothers experience mild to severe nausea in their first trimester of pregnancy and more than half experience vomiting. Doctors often refer to this condition is morning sickness (nausea gravidarum) which is misleading because many women experience the condition throughout the day and night. In rare cases, the condition becomes severe (hyperemesis gravidarum), and often requires treatment and possibly hospitalization for medication and IV (intravenous) fluids. Some doctors prescribe Zofran (ondansetron) to treat morning sickness even though the drug has only been approved for cancer patients who experience nausea and vomiting from chemotherapy, radiation, and surgery.
Rosenfeld Injury Lawyers LLC represents mothers who were prescribed Zofran and suffered injuries, or their baby was born with congenital disabilities. Our law firm has successfully prosecuted cases for our clients who were harmed after taking defective medications. Our attorneys are available to answer any legal questions on how to receive the monetary compensation you deserve if your child was injured because you took a defective medication. Should you have additional questions, we invite you to contact our office for a free review of your legal rights.
The Symptoms of Morning Sickness
Doctors define morning sickness (nausea gravidarum) as a condition that produces nausea and possibly vomiting. Typically, the condition occurs during the expected mother's first trimester and can begin within two weeks or so after conception. The common symptoms associated with morning sickness include:
- Severe nausea
- Severe vomiting
- Nutritional and electrolyte imbalances
- A racing heart
- Vomiting blood
- Intense fatigue
- Unsafe weight loss
- Dizziness or failing faint when standing
- The inability to keep liquids down, leading to severe dehydration
- Passing minimal amounts of urine
- Dark-colored urine
What Causes Morning Sickness
Medical science has yet to determine exactly what causes morning sickness (nausea gravidarum) but is likely the result of hormonal changes associated with the pregnancy. In rare or severe cases, the persistent vomiting or nausea might be the result of a medical condition that is not caused by pregnancy including liver disease or thyroid conditions.
There are specific risk factors associated with pregnancy involving nausea gravidarum including:
- Before you were pregnant, you might experience motion sickness-related nausea or vomiting or were exposed to excessive levels of estrogen through birth control or other medications. These elevated levels of estrogen might produce hot taste or smells or cause to develop migraine headaches.
- Many women who experienced morning sickness in a previous pregnancy will develop the condition in subsequent pregnancies.
- Pregnant mothers expecting twins, triplets or other multiple births have a greater risk of developing morning sickness.
- Pregnant mothers of experience hyperemesis gravidarum are usually pregnant with a girl, have experienced a condition in earlier pregnancies, or have a family history of severe nausea and vomiting condition.
Typically, the condition does not cause mild or severe complications for the baby or the mother. That said, mothers who were underweight before they became pregnant and developed morning sickness might not gain a sufficiently healthy amount of weight to bring their baby to full term. Often, underweight mothers birth underweight babies. Additionally, frequent vomiting can cause the mother's esophagus to tear in rare cases.
Zofran to Treat Morning Sickness
Doctors might prescribe Zofran (ondansetron) to expecting mothers experiencing nausea and vomiting or recommend taking the medication. The drug is often prescribed in liquid form or a resident tablet. Currently, more than one million expecting mothers take Zofran each year to treat morning sickness (nausea gravidarum). The drug manufacturer (GlaxoSmithKline) says that the drug is effective at blocking receptors that trigger nausea.
What is Zofran?
Developed by GlaxoSmithKline in 1991, Zofran (ondansetron) was initially marketed to help cancer patients who experience nausea and vomiting after chemotherapy, surgery, or radiation treatments. The drug received initial FDA (Food and Drug Administration) approval in the early 1990s and is administered orally or via injection.
Eventually, doctors began to prescribe its use to pregnant women "off-label" to treat morning sickness and other symptoms associated with pregnancy. "Off-label" refers to the use of medications for persons, amounts, or symptoms for which they were not intended or approved. Generally, doctors would prescribe Zofran to pregnant women when other medications had not been effective.
However, the FDA currently classifies Zofran (ondansetron) as a “Pregnancy Category B” medication. This classification indicates that there have yet to be any well-controlled studies or comprehensive research about how the medication affects pregnant women. Also, the federal agency has clearly defined a potential link of Zofran to Serotonin Syndrome, a severe condition that increases the central nervous system's cervicogenic activity that affects both the brain and the body. Some women to take the medication are over-energized but experience extreme anxiety.
Zofran and Congenital Defects
Research has shown that Zofran (ondansetron) can cross the placenta exposing the fetus to dangerous levels of the medication and lead to congenital disabilities. The results of an investigation into the dangers of Zofran prescribed during pregnancy was published in the Toronto Star in June 2014. The article revealed that some expected mothers in Canada who had taken ondansetron, the generic form of Zofran, had babies who were born with various Zofran congenital disabilities including:
- Musculoskeletal anomaly
- Mouth deformities
- Kidney defects
- Heart Defect
- Heart murmur
- Restricted fetal growth
- Fetal death
Widely publicized Danish research data from 2013 reported a high incident rate of cardiac malformations in babies born to mothers who had been prescribed Zofran. The study revealed that newborns were twice as likely to develop heart problems if the mother had taken the anti-nausea medication. The following year in 2014, a public Swedish research study revealed that newborns were twice as likely to develop cardiac septal defects if their mother took a dangerous medication within the first trimester of pregnancy.
Alternative Nausea and Vomiting Remedies
Medical science has yet to understand the exact cause of why many pregnant women experience morning sickness (nausea gravidarum). However, there are significant changes that an expectant mother can take to eliminate the common triggers associated with the condition. These changes include:
- Alter Your Diet – Adding sour foods including lemon water and sour candies might reduce the feeling of nausea and make you feel better.
- Take Supplements including vitamin B6 with doxylamine, which is a relatively safe antihistamine drug that is known to improve morning sickness entry allergy symptoms including hay fever.
- Take Formulated Ginger that is known to reduce common morning nausea gravidarum symptoms.
- Increase Liquid Intake especially if you are vomiting often. Drink up to 10 glasses of water or other liquids every day. Additionally, you can hydrate with ice chips between meals. Consider replacing lost electrolytes with sports drinks.
- Never Be Hungry – Never allow your stomach to completely empty. Instead, eat frequent, small meals from the moment you wake up until bedtime. However, keep the meals healthy when possible and nibble on saltine crackers that are known to offset nausea sensations.
- Try Acupuncture or Acupressure – Tiny needles and gentle pressure on specific nerve center areas in the body has proven to be extremely effective in minimizing the symptoms associated with nausea and vomiting.
- Exercise Routinely – Most expectant mothers suffering from morning sickness never feel much like exercising because their stomach feels queasy. However, regular gentle walks can minimize many of the symptoms associated with morning sickness through the body's release of endorphins that are known to counteract a myriad of negative sensations.
- Take Over-The-Counter Drugs – Before taking a heavy prescription medication to treat morning sickness, like Zofran (ondansetron), consider over-the-counter medications including Unisom and Benadryl. These OTC drugs are highly effective in treating insomnia or allergies and might diminish your sensations of nausea and vomiting, especially if your nausea gravidarum begins when you first wake up.
Effectively treating morning sickness can give you your life back and make you feel significantly less queasy throughout the day. However, Zofran (ondansetron) is known to have serious side effects including electrolyte and nutritional imbalance in mothers and congenital disabilities in babies.
Zofran Class Action Lawsuit
Hundreds of families across America have filed Zofran lawsuits against the drug manufacturer claiming that their child was born with serious congenital disabilities after their mother had taken the dangerous medication. Many attorneys working on behalf of their clients are building cases citing that the drug maker failed to notify the public of the serious side effects including congenital disabilities.
In early 2015, plaintiffs began filing Zofran lawsuits after published articles revealed the connection between pregnancy and the increased potential of congenital disabilities. By that time, millions of expecting mothers were caught off guard after they had already taken the medication to minimize their nausea and vomiting conditions. By late 2015, a federal judge in the District of Massachusetts consolidated hundreds of Federal lawsuits into J.P.M.L. (Judicial Panel on Multidistrict Litigation) to speed up the process of moving lawsuits through the court system so that plaintiffs could receive financial compensation for their damages.
The consolidated case (MDL 2657 – RE: Zofran (Ondansetron) Product Liability Litigation) began with 571 lawsuits. However, the number of plaintiffs has grown significantly since then.
Class action lawsuits are tried in federal court much differently than Multidistrict litigation (MDL) cases. Traditionally, a class action suit will be heard as a single case involving hundreds or thousands of plaintiffs who will typically split the jury award equally.
Alternatively, plaintiffs in MDL cases will have their case heard individually after a federal judge consolidates evidence gathering and hears a few cases in bellwether trials. This method helps determine how an individual jury will likely resolve the plaintiff's damages. The results of the jury's finding for the plaintiff or the defendant will set the tone for future negotiation settlements and avoid the need to conduct hundreds of different trials.
Hiring an Attorney is Important
The bad drug injury attorneys at Rosenfeld Injury Lawyers LLC understand that the harm your loved one suffered after taking a defective medication that was not your fault. Our law firm holds pharmaceutical companies financially accountable for their negligence. We have successfully obtained millions on behalf of the victims and their family members to ensure they were adequately compensated to cover their medical expenses, household bills, lost wages, loss of future earnings, pain, suffering, and emotional damage and we can help your family too.
Our legal team encourages you to contact our attorneys today to schedule a free, no-obligation case consultation to discuss the merits of your monetary recovery claim. We accept all personal injury cases, wrongful death lawsuits, and defective drug injury claims through contingency fee arrangements. This legal contract postpones the payment of legal services until after we have successfully completed your case through a negotiated settlement or a jury verdict.
Our law firm gets results quickly because we understand you need money now. We probably offer every client a “No Win/No-Fee” Guarantee, meaning if we are unable to secure financial compensation on your behalf you owe us nothing. All information you share with our law office will stay confidential.
For additional information see the following pages:
- What types of birth defects in children have been associated with Zofran usage?
- Has the FDA issued any warnings concerning the use of Zofran during pregnancy?
- Has there been a recall of Zofran from the market?
- Have there been any lawsuits filed against the manufacturer of Zofran related to birth defects in children?
- If I took Zofran during my pregnancy and my child was born with birth defects, can I file a legal claim or lawsuit to recover compensation for their injuries?
- Are there any time constraints for pursuing a lawsuit related to Zofran-birth-defects?
- What must be alleged in a Zofran lawsuit in Federal Court?
- What damages are available for myself and my child in a Zofran birth defect lawsuit?
- If a took a generic version of Zofran, can I still pursue a legal claim for damages related to my child's birth defects?
- Are there any class action lawsuits against GlaxoSmithKline, the manufacturer of Zofran, for children who have birth defects following Zofran usage during pregnancy?