You might not expect that a medication geared to reduce nausea could cause serious if not life-threatening birth defects, but that may be the case with Zofran, a defective drug launched by British company GSK, or GlaxoSmithKline, toward the latter part of the 1990s.
Also known by its generic name of ondansetron, Zofran was sold exclusively by GSK for its first 15 years on the marketed. In 2007, generic Zofran could be sold by other companies under different names.
Among Zofran complications or side effects are birth defects to the children of women who used the drug while pregnant, perhaps to combat “morning sickness.” Their children then might suffer a cleft palate, cleft lip or missing arms or legs due to the defective drug.
In fact, many Zofran complications can arise, including heart defects such as heart murmurs, ventricular septal defects and atrial septal defects. Use of Zofran during pregnancy also may result in Torsade de Pointes, a dangerous heart rhythm abnormality involving electrical activity in the heart, according to the U.S. Food and Drug Administration (FDA).
Another potential Zofran heart defect is QT interval prolongation. A child also may suffer from an abnormally weak, fast or slow pulse, as well as pain or tightness in the baby’s chest.
Among still more Zofran complications are an irregular heartbeat, or arrhythmia; injuries to the kidneys; jaundice; inadequate growth in the womb; and even fetal death. That’s not to mention potential life-threatening complications for the mother of the child.
Yet no Zofran recall has been issued as of yet by the United Kingdom’s GSK, which continues to rake in profits while innocent American families suffer. Even so, the FDA has mandated strict warnings about Zofran on labels for the product.
Studies and research on Zofran use has found that women who used the anti-nausea medication while carrying an unborn child faced a heightened danger of up to 30% for birth defects in general and up to 20% for heart injury birth defects.
Also, the Toronto Star reported almost 24 cases of kidney damage, musculoskeletal abnormalities and additional birth defects \among women whose used the drug while pregnant.
In another Zofran study, nearly 900,000 pregnancies in Denmark were evaluated over the court of a dozen years. In the end, the researchers determined that women who sued Zofran during the first trimester, or three months, or their pregnancy faced birth defects in 5% of cases, as opposed to 3.5% for women who did not use Zofran.
And, in 2014 it was determined by Swedish researchers that using Zofran while pregnant could increase the risk of a baby having septal heart defects by 100%.
So far, such injuries haven’t kept Zofran from being a big seller for GSK, which has earned as much as $1.3 billion in sales in a nine-month period. Sales declined after generic brands became available, but Zofran still had the distinction of having been on of the Top 20 biggest selling brand name drugs in the United States.
Not only that, but Zofran was the most prescribed drug in America for offsetting morning sickness in the form of vomiting or nausea. Sadly, women who used the drug while pregnant, particularly during their first trimester, then faced a raised risk of their child being born with Zofran birth defect injuries.
Already, Zofran maker GSK has been disgraced for its profitable but illegal procedures. In fct, in 2012 GSK pleaded guilty to resolve civil and criminal liability to the tune of $3 billion, making thi the largest healthcare fraud settlement in the history of the U.S.
A major problem was that GSK illegally promoted Zofran and antidepressants Wellbutrin and Paxil, along with Avandia for type 2 diabetes, for uses which were not approved by the FDA.
In fact, it was found that GSK paid doctors kickbacks in order to get them to prescribe Zofran for uses other than what the FDA had approved in 1991. Zofran was supposed to be prescribed solely for chemotherapy or post-surgery patients to combat nausea, but GSK exploited the huge market of pregnant women by promoting it to them to combat their own nausea or morning sickness.
This move enabled GSK to make tremendous profits, but it also exposed many American infants to severe, life-changing and perhaps even life-threatening birth defects.
Due to GSK’s illegal and disgraceful activities involving Zofran, Americans may need to seek legal remedies by filing Zofran lawsuits. Indeed, such lawsuits are needed by anyone whose child was injured after the mother took Zofran while pregnant.
Such a Zofran lawsuit can target GSK, whose home offices are in Brentford, England, but which also has U.S. headquarters in North Carolina and Pennsylvania. In fact, GSK is the planet’s sixth largest pharmaceutical company, with offices in more than 100 countries.
Notify the Willis Law Firm today for free legal advice about your Zofran injury case. Your family may be legally due significant economic compensation for your losses, including medical costs, lost salary and pain and suffering.