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The Zofran Drug Lawsuit

Zofran (ondansetron) is used to prevent nausea and vomiting in patients who have received chemotherapy cancer treatment, radiation therapy, or who have just had surgery. Zofran works to curb the natural substance called serotonin, which is a chemical in the body that can trigger nausea and vomiting. According to the FDA, Zofran has not been approved for preventing nausea or vomiting that is caused by factors other than cancer treatment or surgery.

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What is Zofran?

Zofran is an anti-nausea medication which can be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. It can be given to adults and pediatric patients age 4 and older, although the pediatric dosage is lower. Ondansetron, marketed under the name Zofran, belongs to the class of medications called 5-HT3 receptor antagonists. Zofran reduces vomiting and nausea by reducing the effects of a naturally-occurring chemical in the body called serotonin. The medication Ondansetron is currently sold under several generic brands and has been approved by the FDA. Drugs which may be equivalent to Zofran ODT are sold by BARR, Glenmark Generics, Mylan, Ranbaxy, Sandoz, Sun Pharm Industries, and Teva. Other less reputable pharmacies may also sell illegal generic versions of Zofran ODT. Medical experts warn about buying certain medications because they can be counterfeit and potentially unsafe.

What is Zofran used for?

Zofran was introduced in the mid-1980s by GlaxoSmithKline and received a United States patent in 1987. In 1991 the drug received FDA approval to be sold in the United States. Its patent expired in 2006 at which time it was considered one of the 20th highest selling brand drugs in the United States with billions of dollars in drug sales. Generic brand medications entered the market in 2006 and were first marketed and sold by Teva Pharmaceuticals USA and SICOR Pharmaceuticals.

  • Ondansetron is currently approved by the FDA for reducing vomiting and nausea in patients receiving cancer treatment or who have recently had surgery. This medication may have other uses not approved by the FDA. For example, it may be used for the treatment of schizophrenia, psychosis resulting from advanced Parkinson\'s disease, and obsessive-compulsive disorder. Pregnant women also may use this medication to reduce the symptoms of morning sickness. Talk to your doctor about the potential benefits and dangers of this medication for other conditions other than controlling vomiting and nausea.

Zofran Usage and Statistics

Zofran, invented in the early 1980s in England by GlaxoSmithKline (GSK), was sold in the United States exclusively until 2006 when the patent expired. The drug generated billions of dollars in sales for fifteen years, ranking as one of the 20th highest selling name brand drugs in the United States. In fact, it was the most frequently prescribed medication in the United States to prevent vomiting. It is also estimated that a majority of cancer patients receive this medication or one similar to prevent nausea and vomiting. Prior to the patent expiration, it was estimated that the annual US sales of Zofran ODT were approximately $225 million per year. In 2007, Teva Pharmaceuticals USA and SICOR Pharmaceuticals were the first companies to begin selling generic versions of the drug.

How Zofran Works

Zofran helps reduce the incidence of vomiting and nausea by blocking the actions of certain chemicals in the body. Specifically, Zofran is a serotonin 5-HT3 receptor antagonist. Part of the success of the drug is its ability to reduce the activity of the vagus nerve, which activates the vomiting center in the medulla oblongata.

Side Effects of Zofran

  • Serious side effects can include:
  • Blurred vision or temporary vision loss (lasting from only a few minutes to several hours)
  • Severe dizziness
  • Fainting
  • Pounding heart
  • Shortness of breath
  • Slow heart rate
  • Trouble breathing
  • Anxiety
  • Shivering
  • Agitation
  • Feeling like you might pass out
  • Slow urination
  • Cough
  • Convulsions
  • Chest Pain
  • Arm, back or jaw pain
  • Chest tightness
  • difficulty swallowing
  • Dry mouth
  • Increased thirst
  • Less serious side-effects:
  • Diarrhea
  • Constipation
  • Weakness
  • Tired feeling
  • Fever
  • Headache
  • Dizziness
  • Drowsiness

Zofran Medical Studies

Ondansetron hydrochloride (HCl) is the active ingredient in Zofran and it acts as selective blocking agent of the serotonin 5-HT3 receptor type. Clinical studies indicate Zofran can successfully prevent postoperative nausea and/or vomiting. According to research, Zofran is “not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively.” But for patients where nausea and/or vomiting must be avoided postoperatively, “ZOFRAN Tablets, ZOFRAN ODT Orally Disintegrating Tablets, and ZOFRAN Oral Solution are recommended even where the incidence of postoperative nausea and/or vomiting is low.” Zofran has also been shown to be effective for the prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, with initial and repeat courses of moderately emetogenic cancer chemotherapy, and for patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen.

Zofran Black Box Warnings

  • Zofran should not be taken if you are allergic to ondansetron, dolasetron (Anzemet), granisetron (Kytril), or palonosetron (Aloxi). Do not take this medicine if you are also using apomorphine (Apokyn). This medication should not be taken if you have liver disease or a history of Long QT syndrome. Although Zofran is not expected to harm an unborn child, it is important to notify your doctor if you are pregnant or planning to become pregnant. Zofran is not approved for children younger than 4 years of age. Medication can be taken with or without food and taken as prescribed by your doctor. In the case of overdose, which can cause sudden loss of vision, severe constipation, feeling light-headed, or fainting, call the 911. Zofran should also not be taken if you are taking certain other medications including but not limited to anagrelide, droperidol, methadone, antibiotics (azithromycin, clarithromycin, erythromycin, levofloxacin, moxifloxacin, pentamidine), certain cancer medications, certain anti-depressants, chloroquine, halofantrine and heart rhythm medications including amiodarone, disopyramide, dofetilide, dronedarone, flecainide, ibutilide, quinidine, and sotalol. C Serious side-effects of ondansetron can include:
  • Blurred vision
  • Slow heart rate
  • Temporary vision loss
  • Trouble breathing
  • Agitation
  • Anxiety
  • Feeling like you might pass out
  • Limited Urination
  • Shivering
  • Slower reaction times
  • Currently there are concerns that ondansetron has been associated with prolongation of the QT interval, which can lead to a potentially fatal heart rhythm. If you experience irregular heartbeat/palpitations, shortness of breath, dizziness, or fainting it is imperative that you seek immediate medical treatment.

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