February 19, 2015 — Experts are warning about the risk of birth defects when Zofran is used in pregnancy, and instead recommending Diclegis (pyridoxine-doxylamine).

Currently, nearly 98% of prescription medications for the treatment of morning sickness are “off-label” (unapproved). Zofran is by far the most popular choice, used by around 1 million pregnancies per year.

Between 2008 and 2013, prescriptions of Zofran during pregnancy increased from 50,000 to 110,000 every month, despite unresolved issues regarding fetal safety and multiple warnings from the FDA about serious heart rhythm side effects that could be deadly for the mother.

In 2013, the FDA re-approved pyridoxine-doxylamine (essentially, a combination of Vitamin B6 and an antihistamine) and classified it as “Pregnancy Category A.” It is specifically marketed for the treatment of nausea and vomiting in pregnancy under the brand-name Diceglis.

In an article published by the American Journal of Obstetrics & Gynecology, Dr. Gideon Koren of the Mortherisk Program recommended:

“Now that a safe and effective drug is available in the United States, there is no reason for women to be exposed to a drug of unproven maternal and fetal safety.”

In comparison, Zofran is “Pregnancy Category B” and recent studies have found a 30% increased risk of birth defects, a doubled risk of heart defects, and a 2.4-fold increased risk of cleft palate.

The manufacturer of Zofran, GlaxoSmithKline (GSK), is now facing a growing number of lawsuits from women who accuse the drug-maker of failing to warn about the risk of birth defects.


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