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Has the FDA Issued any Warnings Concerning the use of Zofran During Pregnancy?

Has the FDA issued any warnings concerning the use of Zofran during pregnancy? The FDA (Food and Drug Administration) issued a Safety Communication Warning stating that Zofran (ondansetron) is being prescribed without approval for treating vomiting and nausea during pregnancy. The federal agency placed Zofran (ondansetron) on the Federal Adverse Event Reporting System (FAERS) database along with other medications known to produce significant health risks. The reporting system provides a single location where doctors and consumers can submit reports directly to the government agency that will evaluate the health concerns made by the public and determine if regulatory action is required.

Rosenfeld Injury Lawyers LLC represents victims who were injured after taking a bad medication and other types of professional negligence. Our law firm has successfully prosecuted cases for our clients who were harmed by pharmaceutical companies that sold defective drugs that are known to produce adverse side effects, like Zofran (ondansetron). Our attorneys are available to answer any legal question on how to receive the monetary compensation you deserve if someone else's negligence caused you harm. Should you have additional questions, we invite you to contact our office for a free review of your legal rights.

What is Zofran?

Zofran (ondansetron) is a 5-HT3 receptor antagonist medication that works by blocking serotonin activity, an essential brain chemical that regulates many body functions including nausea and vomiting response. While the drug is designed to help a large segment of patients in the medical community, the medication is known to worsen many patients' medical conditions and lengthen the time it takes for them to recover.

The History of Zofran

The brand-name Zofran was first developed by Glaxo SmithKline in the 1980s and received its first patent in 1987. However, the FDA did not approve the medication for patient use until 1991. By 2006, generic versions of the drug including ondansetron received quick approval from the federal medication regulatory agency because its ingredients were similar to Zoloft. Since then, the FDA has issued Safety Communication warnings to list contraindications about the safety and efficacy of the drug.

However, the approval for Zofran (ondansetron) was to control vomiting and nausea in patients who underwent surgery or are undergoing radiation therapy and chemotherapy. The FDA never approved any “off-label” use of the medication for expectant mothers suffering morning sickness (nausea gravidarum).

The American Journal of Obstetrics & Gynecology published a report based on the FDA warnings concerning congenital disabilities and babies born to mothers who had taken Zofran (ondansetron). The study warned mothers of the unresolved questions involving fetal health and safety.

Zoloft Manufacturer Warnings

The FDA and makers of Zofran and its generic form ondansetron have issued warnings that some patients might benefit more from taking the medication than others. Some of the common Zofran manufacturer warnings include:

  • Masking Other Medical Conditions – The medication is designed to block the natural vomiting response when the body feels nauseated. Doctors prescribe the medication to encourage healing in pregnant women who are nauseated; it also prevents vomiting that could be caused by some underlying medical conditions. Unfortunately, blocking some symptoms could eliminate the early warning signs of severe health complications.

  • Elevated Absorption Rates – Research shows that women are more likely to absorb Zofran (ondansetron) compared to men and it also takes significantly longer clear the medication from a woman's body or reveal elevated blood plasma levels of the drug in the bloodstream.

  • Zofran and Apomorphine Complications – Patients being treated for Parkinson's disease with apomorphine have an increased potential risk of suffering a loss of consciousness or low blood pressure when taking Zofran (ondansetron).

  • Sensitivity Problems – Some patients who develop hypersensitivity reactions to other 5-HT3 receptor antagonist medications might develop severe adverse reactions when taking Zofran intravenously or through oral administration.

  • Serious Pregnancy Risks – The drug makers have performed numerous reproduction research and studies on the adverse effects of administering Zofran (ondansetron). However, the studies were performed on pregnant rabbits and rats. To date, the pharmaceutical manufacturers have not performed controlled studies on pregnant women. As a result, there is no provable evidence that harm occurs to developing fetuses even though many women who have given birth to newborns with congenital disabilities after their mothers took Zofran (ondansetron) while pregnant.

FDA Warnings

As early as 2011, the Food and Drug Administration began issuing safety communication warnings over specific concerns of the side effects caused by Zofran (ondansetron). Some of these warnings involve:

  • September 15, 2011 – The FDA warns that using Zofran has led to abnormal heart rhythms and changes in the heart's electrical activity. The federal agency warns that taking the drug could cause potentially fatal abnormal heart problems.

  • The FDA warned patients who were at risk of side effects from the dangerous medication. The federal agency warned patients who suffer from certain heart conditions, those taking other drugs that cause QT interval prolongation changes in patients who are predisposed to low blood levels of potassium and magnesium.

  • September 16, 2011 – The following day, the FDA conducted a drug safety podcast for doctors and others in the medical community over the agency's concerns about taking Zofran and developing abnormal heart rhythms. The agency alerted doctors that there were significant problems revealed by patients who had taken Zofran including changes in EKG (electrocardiogram) test results that showed QT interval prolongation and potentially fatal abnormal heart rhythms (Torsades de Pointes).

  • June 2012 – The following year, the FDA released additional information concerning taking Zofran (ondansetron) and developing QT interval prolongation. The federal agency released clinical study pulmonary results that revealed taking a 32 mg single IV dose of Zofran (ondansetron) might cause significant negative changes in the patient's heart electrical activity. The problems could develop a potentially fatal heart rhythm. The FDA mandated that Glaxo SmithKline, the drug manufacturer, updated their Black box warning label and remove the 32 mg IV dosage. Instead of a higher dose, the FDA recommends lower doses to treat vomiting and nausea in children and adults that is induced by chemotherapy.

  • December 2012 – The FDA released a Zofran recall announcement to identify the discontinuation of 32 mg IV doses due to the potential severe cardiac risks associated with taking the drug. However, the federal agency continues to recommend that doctors prescribe the medication to prevent chemotherapy-induced vomiting and nausea. The federal agency still does not recommend prescribing any dose that exceeds 16 mg because of the serious side effects including QT interval prolongation.

  • March 2013 – The federal regulatory agency released its Adverse Events Report that that identified specific potential Zofran Safety Issues including the potential risk of developing serotonin syndrome. This condition can develop within hours after taking Zofran (ondansetron) or upping the current dosage. Many patients who suffer from this condition develop high fevers, seizures, unconsciousness, or an irregular heartbeat.

  • December 2013 – The FDA continued to warn doctors and patients that there were known severe drug reactions to using Zofran (ondansetron) with apomorphine including a loss of consciousness and lower blood pressure. Doctors prescribe the medication to treat Parkinson's disease or help reduce vomiting. The FDA safety warning involved administering the medication orally or through tablets, disintegrating tablets, oral solutions, and injections.

FDA Recommendations

Within months after Zofran (ondansetron) was released in the medical marketplace, the FDA began mandating that drug makers conduct comprehensive research to identify and address the potential risks of adverse side effects. Since then, the federal agency has recommended numerous action by patients who are currently taking Zofran (ondansetron) or about to take the drug. These recommendations include:

  • Inform the prescribing physician about any concerns and questions you have taking Zofran (ondansetron).

  • Ask your treating physician if an electrocardiogram (EKG, ECG) is necessary for your treatment to ensure your heart rhythm and rate is monitored.

  • Seek immediate attention if you experience any of the known side effects associated with taking Zofran (ondansetron), including:

    • Shortness of breath
    • Difficulty in talking or swallowing
    • Loss of consciousness
    • Heart flutters or irregular heartbeat (arrhythmia)
    • Headaches, fever or diarrhea
    • Overall weakness and dizziness
    • Constipation or diarrhea
    • Drowsiness and tiredness
    • Skin rash
    • Hiccups and flushing
    • Seizures
    • Chest pain
    • Severe hives or rash causing peeling and blistering
    • Yellowing eyes or skin
    • Swollen tongue, lips, face or other body parts
    • Dark-colored urine
    • Muscle spasms
    • Blurred vision or temporary loss of vision

  • File a report with the FDA MedWatch program of any side effects or adverse reactions you have experienced after taking Zofran (ondansetron). This information will alert officials that some patients are experiencing potentially dangerous side effects.

Certain Health Conditions Affect Outcomes

Patients who suffer underlying health conditions are potentially at risk for developing Torsades de Pointes (potentially fatal abnormal heart rhythm). Individuals with a family history of heart problems including irregular heartbeats are also at increased risk for serious side effects. Doctors prescribing Zofran (ondansetron) to patients suffering from PKU (phenylketonuria) should ensure they never take the rapidly dissolving tablet form of the medication, which could cause extremely dangerous consequences.

Patients with certain health conditions must take immediate action when taking Zofran (ondansetron) if they have a history of:

  • Liver disease
  • Low potassium
  • Low magnesium
  • Congestive heart failure
  • Heart rhythm issues including congenital long QT syndrome
  • Inherited PKU (phenylketonuria)
  • Taking beta-blockers or other medications and slow the heart rate
  • Taking antibiotics including erythromycin or clarithromycin
  • Taking antidepressant medications including Elavil or Effexor

Submitting a MedWatch Report

The FDA has released a warning regarding the use of Zofran, especially for those with underlying heart issues. It recommends ECG monitoring for those taking it and experiencing electrolyte or heart imbalances. You can read the report here. If you are taking Zofran and experience these problems or any other adverse effect, the FDA encourages you to do the following:

  • Complete and submit the report Online:

  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Obtaining Legal Representation

The bad drug injury attorneys at Rosenfeld Injury Lawyers LLC understand that your loved one's injuries are not your fault. Our lawyers fight aggressively to ensure pharmaceutical companies that manufacture defective medications compensate our clients. 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 bad medication 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.

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