What to Know about Zofran and Birth Defects

Zofran is one of the most popular anti-nausea medications in the United States.  Unfortunately, research is increasingly showing a connection between Zofran and birth defects.  A recent article published in ProPublica suggests that one of the primary reasons why the link between Zofran and birth defects has long gone unnoticed is because most prescription medications are not tested on pregnant women.

In general, prescription medication testing does not include pregnant women due to ethical concerns.  Unfortunately, without this testing, it is impossible to determine whether a medication is safe for use during that sensitive time.  Researchers often refer to pregnant women as “therapeutic orphans” because they rely on taking medications that have unknown risks. This is especially true during the first months of pregnancy when fetal development is crucial.  Furthermore, researchers believe pregnant women to be possibly the most underrepresented group in clinical research.

Zofran and Birth Defects: Information

Zofran, generically known as ondansetron, is manufactured by GlaxoSmithKline, one of the largest pharmaceutical companies in the U.S.  It is the most common medication doctors prescribe to treat acute nausea from chemotherapy, radiation, surgery or cancer.  Prescribing Zofran for morning sickness during pregnancy is known as “off-label” prescribing. Off-label means that doctors prescribe it for a condition other than what is on the U.S. Food and Drug Administration’s (FDA) label.

The fact of the matter is that Zofran does not have FDA approval for use during pregnancy.  In fact, the FDA lists Zofran as a Category B drug. That means that there are no “adequate and well-controlled studies in pregnant women” to determine potential risks or side effects.  The only testing of Zofran involves animals in a laboratory setting, which is not sufficient to determine the risks to humans.

Three decades ago, another drug to treat morning sickness became popular, and was believed to be safe for use during pregnancy.  This drug is thalidomide. Unfortunately, an increasing number of women taking the drug gave birth to babies with severe deformities.  Thalidomide was banned in the 1960’s.  Shortly thereafter, another drug, Bendectin, became popular and even received FDA approval.  Though Bendectin had a track record for safety, a number of lawsuits emerged claiming that it caused birth defects. This led to the manufacturer eventually pulling the drug from the market.  Since that time, no drugs to treat morning sickness have received FDA approval.

Zofran and Birth Defects: Controversy

As more claims of a connection between Zofran and birth defects have emerged, GlaxoSmithKline continues to argue that the drug does not cause birth defects.  Independent research on the matter has been largely inconsistent about such a link.  Remember, most of the research conducted has been registry-based. That means that the research is based on various experiences and pregnancies studied after-the-fact.

Another component to the controversy of Zofran and birth defects is the fact that protecting pregnancies is something of a double (or even triple) edged sword. 

• First, most scientists find it unethical to conduct testing on pregnant women to determine what may contribute to birth defects. 
• Second, the same desire to protect pregnancies is hindering research. That means doctors are using “guesswork”, including off-label prescribing of medications not approved for use during pregnancy, which may pose risks to the pregnancy. 
• Third, If a pregnant woman is taking medication and her doctor decides it is best to stop taking it, there is a further risk of adverse side effects from any underlying conditions no longer being treated.

Lack of Research Among Pregnant Women

Because there is a severe lack of research during pregnancy, most of the prescriptions women receive during pregnancy are off-label. This is a serious concern.  There is an attitude that – if doctors prescribe off-label medications during pregnancy anyway, what is the incentive for drug manufacturers to test the drug in pregnant women before getting approval?  This vicious cycle is not only dangerous, but goes against everything that doctors should stand for in their practice.

21 million Zofran prescriptions were written in 2015 across all diagnoses. While many doctors continue to prescribe Zofran during pregnancy, it is illegal for pharmaceutical companies to encourage prescribing drugs for off-label use.  In 2012, GlaxoSmithKline landed in hot water with the U.S. Justice Department, which announced the company had crossed that line.  The DOJ alleged that GlaxoSmithKline was enticing doctors with perks, while misreporting trials and findings. Additionally, they were withholding information from the FDA, and paying doctors to prescribe and promote Zofran to patients with morning sickness.  Ultimately, GlaxoSmithKline did not admit wrongdoing. However, they were required to pay a $3 billion fine for wrongdoing after pleading guilty to other allegations.

The Facts about Medication Use and Pregnancy

The issue of medication use during pregnancy goes far beyond Zofran and birth defects. In fact, it extends into the realms of medical malpractice and medication errors.  Zofran is a catalyst, however, in highlighting the issue of medication use during pregnancy. It also highlights the lack of adequate research and precautions.  Consider these statistics, which signify how prevalent a problem this issue really is:

• Research in 2013 indicated that 95% of all industry-sponsored drug trials excluded pregnant women. Only 1% was specifically designed to target them.
• Less than 10% of all medications are considered to have enough information to determine if they are safe for use during pregnancy.
• The Centers for Disease Control and Prevention (CDC) indicates that up to nine out of every 10 pregnant mothers take prescription medication. The reasons are symptoms during pregnancy, or for other conditions.
• Advocates estimate that the average time it takes for the FDA to issue a “black box” warning after consumers report adverse events is as much as 27 years.

With so many women requiring prescription medication, it begs the question of why researchers and drug manufacturers are not aggressively taking action to protect women and babies. After all, pregnancy is a common component of life for millions of women.

Researchers with the FDA further note that the body of a pregnant woman is significantly different from that of her non-pregnant counterparts. This makes it nearly impossible to compare the effects of a drug between the two groups.  There are many physiological changes during pregnancy that can affect the way a drug reacts.  So many changes, in fact, that some researchers contend that pregnant women are unfit to provide informed consent. This categorizes them among children and patients with mental disabilities.

What Pregnant Mothers Need to Know

All of the information provided here culminates to this – if you are pregnant, be extremely cautious about what medications you take.  Avoid taking Zofran if possible, and talk to your doctor about other options.  Research has shown a link between ondansetron product use and increased risk of birth defects like cleft palate and heart defects.  Currently, there are more than 200 lawsuits pending involving Zofran and birth defects.

If you believe that your child has a birth defect due to exposure to ondansetron, or any medication, you deserve to know about your rights and your options to pursue justice for your family.  Taking on a product manufacturer in court can be a complicated process, but you deserve to have your voice heard. What’s more, manufacturers and healthcare providers should be held accountable when their actions harm others.

To find out more about medications during pregnancy, birth defects, or other medical malpractice concerns, contact MedMalFirm.com. Request a free consultation with one of our attorneys to discuss your case.  You can contact us by filling out our online form, or by calling 877-887-4850.