Zofran Prescribed to Pregnant Women Despite Known Risks

San Diego, CA — March 9, 2015

One of the most ubiquitous struggles during pregnancy is morning sickness. The nausea and vomiting during a woman’s pregnancy can be overwhelming, not only during the morning, but throughout the day. Some of the most common drug remedies for morning sickness are Vitamin B6, Zantac, Pepcid, and other anti-nausea medications. Somehow, despite the knowledge of unreasonable risk and cause of birth defects, Zofran has started to make its way onto those lists of recommendations.

GlaxoSmithKline is the maker of the drug Zofran (technically known ondansetron) which was developed to help treat the nausea that cancer patients deal with after surgery. Then, without any FDA approval, GlaxoSmithKline began targeting pregnant women as a new market for Zofran. Not only was the drug lacking FDA approval, but GlaxoSmithKline was well aware of the direct risk that Zofran presented.

Unfortunately the most common side effect of taking Zofran during pregnancy are terrible birth defects. Once the FDA realized this, they began warning potential patients. Regardless of these warnings, doctors in the United States and now more frequently in Canada, have continued prescribing Zofran to pregnant women. These off-label treatments are continuing to destroy the health of children born from women taking Zofran.

How is Zofran supposed to help treat “morning sickness”?

Zofran is intended to get in between the chemicals that cause vomiting and nausea, ultimately blocking these effects of morning sickness. The typical relief methods of morning sickness are consuming simple meals and maintaining a diet that does not overwhelm the senses. Zofran is typically taken once or twice a day, usually after these non-drug remedies fail to work and patients start to turn towards prescriptions to bring relief to the pains that morning sickness can cause.

What are the dangers of taking Zofran during pregnancy?

Because morning sickness is typically experienced during the first trimester of pregnancy, and is the most vulnerable period of development for an infant, Zofran can deeply affect their growth. The worst side effects that have been documented as a result of Zofran are:zofran cleft palate

  • Mouth deformities (Cleft lip and cleft palate)
  • Heart abnormalities, pains, weakness, and palpitations
  • Skin discoloration
  • Muscle and skeletal defects

Once these defects and abnormalities started piling up, GlaxoSmithKline started updating labels in collaboration with Health Canada. GlaxoSmithKline claims that the dangers of their drug Zofran are due to “abnormal electrical activity in the heart when used in high doses.” Despite their deep understanding that Zofran can double the risk of birth defects and is a direct danger to pregnant women; GlaxoSmithKline continues to market Zofran as a solution for nausea during pregnancy.

What is being done about the irresponsible prescription of Zofran?

Multiple Canadian women who were prescribed Zofran have started to take action against GlaxoSmithKline. The last-second efforts to minimize GlaxoSmithKline’s seeming awareness of the risks have done little to help those who have been affected by the drug’s defects. Motherisk, a Canadian organization that helps educate pregnant mothers on medical concerns, have received almost 200 calls asking for help dealing with the defects caused by Zofran.

Lawsuits addressing GlaxoSmithKline’s failure to ensure the safety of their drug before offering it to the public have spearheaded the campaign of paying for damages caused by Zofran. Other lawsuits have involved GlaxoSmithKline advertising the drug as a safe treatment, misrepresenting studies showing Zofran’s toxicity, claiming Zofran is safe specifically for pregnant woman, and failing to measure the data and safety information of their drug correctly.

The off-label prescription and marketing manipulation carried out by GlaxoSmithKline is not your fault. The experience of pregnancy and childbirth can be a terrifying journey, especially when a woman’s trust is betrayed by a pharmaceutical corporation that is willing to deal pregnant mothers a drug with known risk.

If you or someone you know took Zofran and had a baby born with these side effects please contact us today.

Contact us today at 1-800-214-1010.

Zofran form

Other sources: Motherisk determines that Zofran is not safe to take during pregnancy