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Zofran and Ondansetron Litigation

 

Zofran, also known by its generic name ondansetron, is a prescription drug that blocks chemical reactions in the body that cause nausea and vomiting.  The drug works by blocking serotonin, a neurotransmitter, in the body, which is the natural substance responsible for nausea.  Zofran is a type of medication called an antiemetic and is part of 5HT3 receptor antagonists.  The drug is typically used to prevent nausea and vomiting caused by surgery or cancer drug treatment such as radiation and chemotherapy.  Because Zofran treats nausea and vomiting, it has been prescribed to pregnant women as a treatment to morning sickness.  Zofran, Zuplenz (another brand name for ondansetron) and the generic are only approved to treat nausea and vomiting after cancer treatments and surgery.  However, doctors often prescribe them for unapproved uses such as morning sickness in pregnant women and treating stomach problems in children.  The manufacturer of Zofran acknowledged the new potential for their product and began advertising to doctors and expecting mothers the relief that the drug could offer to pregnant women.  Many women turned to Zofran as a respite for their morning sickness, but recently data has linked the drug to birth defects.

Who manufactures it?

GlaxoSmithKline (GSK) is a British pharmaceutical company stationed in Brentford, London.  The company is the sixth largest pharmaceutical company as of 2015.  The company describes itself as “a science-led global healthcare company with a mission: we want to help people to do more, feel better, live longer” on its website.  GSK is known for its global initiative to develop medicines that are affordable in developing countries.  Additionally, GSK has recently partnered with Pfizer, another pharmaceutical company, to establish ViiV, a company devoted to the fight against AIDS and rebuilding the health of communities affected by HIV.  Other noteworthy acts include GSK’s partnership with the World Health Organization.  GSK donated 100 million albendazole tablets in 2002 as treatment against intestinal worms.  GSK is also one of the largest vaccine companies worldwide, dispensing over 1.1 billion doses of vaccines to 173 countries.  GSK had a relatively pristine reputation in the past, but in recent years, their company has been tarnished through several damaging discoveries.  One of their drugs, Avandia, was the world’s most popular diabetes pill until it was linked to an increased risk of heart attack.  Another scandal occurred when GSK was caught with illegal marking and withholding of data in 2012.  Additionally, the company has had problems with Zofran, Paxil and Wellbutrin (antidepressants), and Advair (used to treat asthma).

What are the side effects?

Zofran, Zuplenz, and the generic ondansetron are labeled as Pregnancy Risk Category B.  This classification means that there is no evidence that the drugs are hazardous to humans.  This fact, along with GSK’s advertising of the drugs as treatments for morning sickness in expecting mothers, assured mothers that the drug was safe for them and their babies to take.  However, this led to a variety of birth defects, including mental, vision, and stomach problems, club foot, physical deformities, heart defects, cleft lip/palate, webbed toes, hearing loss, abnormal blood pressure, and skull deformities.  In a 2014 study by Dr. Gideon Koren, taking Zofran or similar drugs while pregnant caused a “2-fold increased risk of cardiac malformations, leading to an overall 30% increased risk of major congenital malformations.  Zofran can also have dangerous side effects for the mother.  Such side effects include Serotonin Syndrome, a life-threatening condition that causes high fever, irregular heartbeat, seizures and unconsciousness and QT Syndrome, a syndrome that can cause erratic heartbeats.

What is the status of legislation?

Recall the FDA never approved Zofran for use by pregnant women.  In 2006, Zofran lost is patent, so doctors began prescribing generic versions of the drug.  In 2012, GSK plead guilty to federal charges of fraud and illegal advertising of numerous drugs like Zofran.  GSK is currently fighting more lawsuits involving Zofran.  Court documents used in lawsuits against GSK argue that the company knew the harmful effects to developing babies that could result from using Zofran.  Various claims again GSK include, “Glaxo had a duty to ensure its drug was safe before offering it to the public and failed to determine safety risks before selling it”, “Glaxo failed to warn the public about dangerous side effects”, and “Glaxo falsely and fraudulently claimed Zofran was safe for pregnant women”.  Most claims consider the question as to whether a drug manufacturer is liable for injuries sustained by babies whose mothers took its pharmaceuticals during pregnancy.

If you have taken Zofran and find yourself suffering from some the dangerous side effects of the drug, call the drug injury lawyers at Altman & Altman LLP for a confidential consultation to see if you can bring a claim.

 

“About Us.” GlaxoSmithKline. N.p., n.d. Web. 2 June 2016.

“GlaxoSmithKline-Drug Manufacturer History & Products.” DrugWatch. N.p., 4 Dec. 2015. Web. 02 June 2016.

“Zofran.” Web MD. N.p., n.d. Web. 2 June 2016.

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