1. Lawsuits Claim Anti-Nausea Drug Zofran Causes Birth
Defects - Press Release
But as court documents note, Zofran's pregnancy-related labeling information has remained
unchanged since 1993. GlaxoSmithKline has never sought Zofran's approval for use as a morning
sickness treatment, and has never conducted the trials involving pregnant women that would be
necessary for such approval.
Despite having no evidence of Zofran's safety during pregnancy, physicians have been prescribing it
to alleviate the symptoms of morning sickness for more than two decades. Researchers in Denmark
and Sweden have found a link between Zofran and congenital heart defects, while scientists at
Harvard University observed increased risks of cleft palate. A team in Australia found that exposure
to Zofran's active ingredient was associated with a six-fold increase in the rate of kidney defects.
As for this evidence of Zofran's potential to increase the risk of major birth defects, plaintiffs say
GlaxoSmithKline has remained silent. Now they claim that GlaxoSmithKline has been aware of the
alleged risk Zofran presents during pregnancy for over two decades. Monheit Law is currently
offering free case evaluations. Families say that the company has received mounting evidence of
Zofran's potential to cause birth defects, but has done nothing to warn the public or physicians.
Zofran is a powerful nausea medication, approved by the US Food Drug Administration to treat
three specific forms of nausea and vomiting. The Justice Department filed both civil and criminal
charges against the company, including allegations that GlaxoSmithKline had promoted several
drugs directly to members of the health community for off-label use.
One of the drugs named was http://www.rxlist.com/zofran-drug.htm Zofran. They cite more than 200
accounts of birth defects with suspected ties to Zofran, reports that GlaxoSmithKline allegedly
received but failed to report to the FDA.
Many of these parents also refer to several epidemiological studies in which researchers have
investigated Zofran's possible effects on unborn children.
In the first months of 2015, at least 7 parents have filed lawsuits against GlaxoSmithKline, the
manufacturer of a drug they say causes birth defects.
All 7 mothers gave birth to children with major birth defects after taking Zofran to alleviate the
symptoms of morning sickness during early pregnancy. Drug manufacturers, on the other hand, are
barred by federal law from promoting their products off-label.
In 2012, the federal government saw the culmination of an investigation into GlaxoSmithKline's
marketing practices that had begun in 1997. More information can be found at Zofran.Monheit.com.
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Contact ZofranLegal.com:
Michael Monheit
2. 1-877-620-8411
michael@monheit.com
1368 Barrowdale Road, Rydal, PA 19046
. Parents claim that the company was both obligated and able to revise Zofran's warning label and
notify the public and medical community of the drug's association with birth defects. Because the
company had never studied Zofran's effects in pregnant women, federal prosecutors said that any
claims as to its safety or efficacy as a morning sickness treatment were necessarily "unsubstantiated
and / or false representations."
While the company has always denied these allegations, new Zofran birth defect lawsuits insist that
GlaxoSmithKline promoted the drug for off-label use during pregnancy.
In her complaint, filed in the Superior Court for the State of California, County of Alameda, the
plaintiff in case RG15761042 alleges that "GSK knowingly avoided conducting [studies to investigate
Zofran's effects in pregnancy] because they would have hampered its marketing of Zofran and
decreased profits." Some of these parents have gone so far as to say that GlaxoSmithKline's alleged
conduct "was tantamount to using expectant zofran birth defects pubmed mothers and their unborn
children as human guinea pigs."
Contrary to Zofran's safety in pregnancy, plaintiffs say GlaxoSmithKline has actually received
evidence that exposure to the drug can increase the risk for birth defects. Estimates have placed the
number of prescriptions written for Zofran to treat morning sickness at over 1 million per year.
Doctors are not prohibited from prescribing drugs for unapproved uses. The government claimed
that GlaxoSmithKline had promoted Zofran to doctors as "safe and effective" during early
pregnancy. If the allegations in these lawsuits are true, many other families may be eligible to file
Zofran birth defect lawsuits. Based on clinical data submitted by GlaxoSmithKline, the FDA has
found Zofran safe and effective in controlling nausea that can follow chemotherapy, radiotherapy
and surgical anesthesia. Rather than discourage the drug's use in pregnant women, plaintiffs say
that GlaxoSmithKline chose to promote it as a treatment for morning sickness.
Joined by an alliance of plaintiffs' attorneys, Monheit Law is investigating the claims of parents who
believe that prenatal exposure to Zofran may have caused their child's birth defects. In fact, this
practice, referred to as "off-label" prescription, is common and completely unregulated by the FDA.
To date, four studies have found that women prescribed Zofran's active ingredient in early
pregnancy are at a significantly increased risk of delivering babies with major birth defects