The Zofran Lawsuit concerns the use of the prescription drug Zofran and the growing body of evidence linking this drug to an increased risk of birth defects.
The lawsuit alleges that the manufacturer of Zofran knew of this severe side effect, but failed to properly inform the United States government and healthcare providers that Zofran could cause significant potential issues, and that the drug required additional testing and research before it should have been widely marketed and prescribed to patients who had better alternative treatments.
What is Zofran
Zofran is the brand name for a prescription medication known as ondansetron hydrochloride. It is classified as a serotonin 5-HT3 receptor antagonist. Serotonin is a type of neurotransmitter, a chemical produced in the brain that relays information between nerve cells. Serotonin is found primarily in the lower gastrointestinal tract, where it plays a role in the movements of the intestines. The 5-HT3 receptor is the specific protein molecule that receives serotonin signals. When this particular receptor is activated by a substance (such as alcohol), it can cause nausea and vomiting as well as anxiety, and in some cases, increase the likelihood of seizures.
Zofran, which has been available in generic form since 2006, may be taken orally or by injection.
Why Do Physicians Prescribe Zofran
Zofran is normally given to cancer patients undergoing chemotherapy and radiation treatments in order to prevent nausea and vomiting. It has been aggressively promoted for the ‘off-label’ purpose of treating symptoms of morning sickness in pregnant women. Studies since the drug has been available in generic form indicate that ondansetron may be useful in treating psychiatric and psychological disorders.
What are the Side Effects of Zofran
Commonly reported side effects of Zofran include headaches and dizziness as well as constipation. A few patients have reported damage to the inner ear as well, though these have not been confirmed. The medication has also been associated with a potentially fatal form of arrhythmia (irregular heartbeat), known as torsades de pointes. Patients should avoid operating machinery while taking Zofran, as it may impair cognitive function and reaction time.
A number of articles have been published in medical journals, presenting evidence that suggests a link between the use of Zofran by pregnant women and birth defects. Although the issue is still being debated and studied, the general consensus among medical professionals is that Zofran should not be considered as a treatment for morning sickness unless all other treatments have failed. It has been established that Zofran can be transferred to the fetus through the placenta up to twelve weeks after conception.
What Does the Government Say About Zofran
The Food and Drug Administration (FDA) has issued warnings of the increased risk of heart problems and recommended ECG monitoring for patients suffering from an imbalance of electrolytes (electrically-charged minerals in the bloodstream).
What Do Medical Studies Say About Zofran
There is little consensus in the medical community about whether or not Zofran causes birth defects at present. However, a January 2012 study from the Center for Birth Defects Research and Prevention indicates that women taking Zofran for nausea and vomiting during the first trimester of pregnancy were twice as likely to give birth to a child with a cleft palate. A more recent study published in Reproductive Toxicology presents possible links between the use of Zofran and specific birth defects that affect the heart as well.
Has There Been a Recall of Zofran Resulting From Birth Defects
As of this time, there has not been a recall of Zofran related to birth defects. However, the investigation into this drug, from a legal standpoint, is still at its early stages. It often takes many years; tens of thousands of hours of attorney time; and the expense of many millions of dollars before all the facts come out that will lead to a voluntary or involuntary recall.
Who Produces Zofran
Zofran is a product of Glaxo-Smith-Kline (GSK), a multi-national pharmaceutical corporation based in Brentford, England. The sixth-largest pharmaceutical company in the world, GSK is the result of a series of mergers and acquisitions going back 125 years. In addition to Zofran, GSK produces a range of drugs for the treatment of cancer, diabetes and asthma, as well as psychopharmaceuticals for mental conditions. GSK also manufactures and markets a number of popular over-the-counter medications, dental and oral care products and nutritional supplements.
What is Known About GSK
The original company was founded in Bunnythorpe, New Zealand, in 1904 as a manufacturer of infant formula. The company opened operations in London, England as Glaxo Laboratories in 1935. Over the latter part of the 20th Century, the company acquired and merged with a number of others. By 1999, Glaxo-Wellcome commanded the third-largest revenue stream in the industry. The present corporation was formed the following year when Glaxo-Wellcome merged with SmithKline-Beecham.
Over the past decade, GSK has faced a number of criminal charges as well as civil lawsuits over various products and business practices. In 2007, there were serious concerns about the company's popular diabetic drug Avandia (rosiglitazone), which was implicated in an increased the risk of congestive heart failure, liver toxicity, stroke and dangerous hypotension (abnormally low blood pressure). A few years earlier, GSK paid $2.5 million in order to settle charges of fraud for off-label marketing of the antidepressant Paxil (paroxetine) to pediatric patients and suppressing negative research information on the drug. In 2010, GSK was fined $750 million over the manufacture of defective and adulterated products at a Puerto Rico subsidiary.
In 2012, GSK pleaded guilty to criminal charges for marketing Paxil and Wellbutrin (another antidepressant) as well as Zofran for “unapproved uses” and failure to report potential safety issues about Avandia. In the whistleblower case, information came out about kickbacks to physicians as an incentive to prescribe GSK products. GSK was also found guilty of defrauding the Medicaid Drug Rebate program. Ultimately, GSK paid out $3 billion in fines and restitution – the largest judgment against a pharmaceutical corporation to date.