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March 8, 2018

Approved and Unapproved Uses of Zofran

What Patients Need To Know Before Taking Zofran®

Many patients rely on anti-nausea drugs after major medical procedures. Surgery, cancer treatments, and other necessary medical care can have widespread effects on a patient’s digestive system, and a loss of appetite can affect a patient’s ability to heal and recover. However, anti-nausea medications are not without risks, and should only be taken by patients who can tolerate both the benefits and side effects.

What Is Zofran®?

Zofran and related medication Zuplenz® are prescription antiemetic medications. These drugs, known as 5HT3 receptor antagonists, block a Nausea Tag With a Stethoscopeneurotransmitter called serotonin, which can trigger nausea and vomiting. Zofran was approved by the Food and Drug Administration (FDA) in 1992, giving drugmaker GlaxoSmithKline permission to manufacture and market the drug. In 2007, the FDA approved ondansetron (the active ingredient in Zofran) for generic use by several drug companies.

Zofran has been associated with many serious side effects including:

  • Slow heart rate
  • Blurry vision or temporary vision loss
  • Breathing problems
  • Anxiety
  • Shivering
  • Feeling faint
  • Decreased urination.

Patients are advised to contact their doctors immediately if they suffer any of these side effects. In addition, ondansetron can impair the ability to think clearly and dull reaction times, so patients should take extra care when driving or performing activities that require quick movements or sound decision-making.

Who Should Not Use Zofran?

Zofran oral dosage was approved to treat nausea and vomiting after surgery, prevent radiation-induced nausea, and reduce or prevent vomiting due to chemotherapy. Additional uses include treating excessive vomiting in children suffering from severe gastroenteritis and preventing uncontrollable shivering in patients who have undergone anesthesia.

However, some patients are not good candidates for treatment with Zofran, including:

  • Pregnant women. Doctors increasingly prescribe Zofran for morning sickness in pregnant women. However, the drug was never approved for this use, and has been linked to birth defects and developmental problems in unborn children.
  • People with medication allergies. Anyone who is allergic to ondansetron or similar medications, such as dolasetron (Anzemet), granisetron (Kytril), or palonosetron (Aloxi), should not use Zofran.
  • Phenylketonurics. The disintegrating tablets of Zofran oral may contain a sugar substitute called phenylalanine, placing patients with phenylketonuria (PKU) at risk of severe side effects.
  • People with liver disease. Patients with a history of liver disease, abnormal liver function tests, or a family history of Long QT syndrome should discuss these conditions with their doctors before taking Zofran.
  • Patients with heart problems. In 2011, the FDA released a safety warning alerting patients of the possibility of abnormal heart rhythms when taking ondansetron. The drug may cause changes in the electrical activity of the heart, leading to rapid, uncontrollable heartbeat that can be life-threatening.
  • Breast-feeding mothers. Researchers are unsure if ondansetron can be passed to children via breast milk, so nursing mothers should discuss breast-feeding with their doctors.
  • Patients with Parkinson’s disease. Patients taking apomorphine (Apokyn) for Parkinson’s disease should not take ondansetron, as the interaction between the drugs may cause dangerously low blood pressure.
  • Young children. Zofran is not recommended for use in children younger than 4 years of age.

How Will I Know if Zofran Harmed My Baby?

One of the most fretful complications of Zofran is the potential to harm a developing fetus. As nausea is typically worse in the first few months of pregnancy, pregnant patients are often prescribed Zofran during the child’s most important stage of development. The baby’s brain and other organs are formed during the first trimester, and can be negatively impacted by ondansetron.

Unfortunately, women may not be aware that Zofran has caused injury to their child until after the baby is born. Reported injuries include:

  • Low fetal weight (below the 10th percentile)
  • Liver damage
  • Heart defects (such as holes in the heart)
  • Musculoskeletal abnormalities (such as clubfoot or bowed legs)
  • Skull and mouth deformities
  • Cleft lip or cleft palate
  • Vision or hearing problems
  • Cognitive or developmental problems
  • Increased risk of spontaneous abortion or stillbirth

If you or your child was harmed as a result of Zofran while pregnant, we can help you take action against the maker of this dangerous drug. The McGartland Law Firm can fight on your behalf to get proper compensation for permanent disabilities and life-altering injuries, and we do not collect legal fees unless we win your case. Contact us today using our online contact form or by calling the number on this page.

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