Zofran – Side Effects, Recall and Lawsuits
Zofran is the brand name for the generic medication, odansetron hydrochloride. It is manufactured by the UK-based pharmaceutical giant, GlaxoSmithKline (GSK) which has operations in 115 countries and estimated annual revenue of $35 Billion.
Zofran is approved to treat or prevent nausea and vomiting in patients receiving chemotherapy or radiation therapy for cancer treatment and in surgery or post-operative related nausea. It is available as an oral tablet, oral solution, oral disintegrating tablet and as an injection for intravenous use.
Zofran works by blocking the 5-HT3, serotonin receptors on the vagal nerves which run from the stomach to the throat and in the “chemoreceptor trigger zone” or CTZ in the brain and is often very effective when used as prescribed.
Zofran has also been used as an “off-label” treatment for pregnancy associated nausea and vomiting. Physicians are allowed to use medications as off-label treatment if they feel that risks outweigh the benefits however drug manufacturers are not allowed to promote or market medications for this type of use.
GSK has paid $3 Billion to the Department of Justice to settle allegations of improper marketing of Zofran and studies have shown that Zofran increases the risk of severe birth defects when used in pregnant women.
Zofran Side Effects
Like many medications, Zofran may cause side effects. Most of these side effects are mild or temporary, however some can be more severe and may cause significant injury.
The most common side effects of Zofran include:
- Rash and itching
More severe side effects may indicate changes in heart rhythm including:
- Irregular heartbeat
- Shortness of Breath
In some cases, patients who take Zofran may experience EKG changes such as QT prolongation which may cause a serious and possibly fatal heart arrhythmia known as Torsades de Pointes. This possible risk prompted the FDA to issue warnings about dosages over 16 mg and led to the recall and discontinuation of the 32 mg dosage of Zofran.
Zofran Birth Defects
Zofran is listed as a Category B medication for pregnancy. Pregnancy Category B indicates that the medication has not been proven safe for uses in pregnancy but many women have been prescribed Zofran for morning sickness.
About 15 percent of all pregnant women experience “morning sickness” which is severe enough to warrant medication. Nausea and vomiting may persist throughout a pregnancy and in some cases, may be severe. However, most nausea and vomiting occurs during the first trimester of a pregnancy when the developing fetus is most vulnerable to damage caused by medications.
Studies have shown that Zofran readily crosses the human placenta and most women who have taken Zofran during pregnancy used it during the first trimester.
Zofran use during pregnancy has been shown to double the risk of cleft palate and fetal heart defects and may increase the overall birth defect rate by as much as 34 percent.
Potential birth defects caused by Zofran may include:
- Congenital heart defects
- Cleft palate
- Kidney malformation
- Skeletal defects
- Fetal growth restriction
- Spontaneous abortion
Zofran Recall and Settlement
GSK was warned by the Food and Drug Administration as early as 1999 regarding improper marketing practices of Zofran. The FDA cited the company for inadequate representation of side effects and risks of the medication.
In 2011 , GSK was required to conduct a cardiac effects study which concluded that doses over 16 mg of Zofran increased the risk of the potentially fatal cardiac arrhythmia, Toursades de Point. GSK was forced to recall a 32 mg injectable dosage formulation of the medication in 2012.
In 2012, GSK paid $3 billion in criminal and civil penalties to settle Department of Justice allegations that the company had promoted Zofran for off-label use in pregnant women and had unlawfully paid kickbacks to physicians for prescribing the medication.
Even though GlaxoSmithKline has paid a settlement of $3 Billion, this has not released the company from liability for damages or injuries that may have occurred due to Zofran use.
A child or the family of a child who was injured because the mother was given Zofran during pregnancy may be entitled to compensation for damages. Monetary damages awarded to those injured by medications may include coverage of medical costs, lost wages and pain and suffering. In some cases, victims may be awarded punitive damages, which are intended to punish the manufacturer for knowingly promoting or selling a harmful medication.
Many lawsuits against GlaxoSmithKline regarding Zofran use during pregnancy may be expected, potentially resulting in $Millions in damages to be awarded.