Drug Linked to Potential Birth Defects

Zofran is a drug used to combat severe morning sickness in pregnant women. The anti-nausea drug has been linked to birth defects such as cleft palate, cleft lip and heart problems in babies, according to published research and news reports.

Doctors have been quick to prescribe Zofran as “off-label” even though it’s not approved by the FDA, and its safety for use during pregnancy remains uncertain. The FDA has previously issued a warning regarding Ondansetron, which is marketed as Zofran. The U.S. regulatory agency has cautioned against its use during pregnancy after studies showed a relationship between Zofran usage in the early stages of pregnancy and heart issues and oral clefts.

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Brief History of Zofran

The pharmaceutical company GlaxoSmithKline initially manufactured Ondansetron to prevent and alleviate nausea and vomiting in cancer patients after they underwent surgery, chemotherapy and radiation. The FDA approved the drug in 1991.

What You Need to Know About Zofran

Zofran is not FDA-approved as mentioned earlier. In fact, there aren’t any drugs that are currently FDA-approved to treat morning sickness in the U.S. However, the FDA hasn’t restricted the sale of Zofran. Physicians can legally prescribe the anti-nausea drug to pregnant women.

How the Drug Works

Zofran belongs to class of medications known as 5-HT3 receptor antagonists. The drug blocks the action of serotonin, which is a natural substance that may cause vomiting and nausea.

The medication is usually taken via an orally swallowed tablet. The medicine can be taken once or twice a day. The drug is even available as a dissolvable wafer and injection.

Zofran is typically administered to pregnant women during the first trimester, which is when 70 to 80 percent of women experience nausea and vomiting.

As is the case with any drug, a doctor must inform a pregnant patient about potential issues with Zofran that may affect the mom and unborn child. Patients have the right to know about the drugs.

Zofran birth defects

Recent studies and news reports have shown potential relationships between Zofran and certain birth defects. Here is a sampling: