Information about Zofran.

Parents becoming aware of Zofran birth defects risks

August 30th, 2015

Parents are becoming increasingly aware of the risks of birth defects associated with anti-nausea drug Zofran as news of the serious side effects spreads. An article on notes that at least 4 studies have linked the drug to an increased risk of serious birth defects among children born to women who use Zofran during pregnancy.

According to the article, Zofran manufacturer GlaxoSmithKline denies knowing the drug could be linked to birth defects, despite animal studies conducted in the 1980s showing the active ingredient in Zofran may cross the placental barrier into the fetus. The company allegedly received 32 official complaints of Zofran-related birth defects prior to 2000 and at least 200 more since then.

Zofran has only been approved to treat nausea in post-surgery patients and patients undergoing cancer therapy. However, each year more than 1 million prescriptions of Zofran are given to treat morning sickness in pregnant mothers — an unapproved use of the drug.

In 2012, GlaxoSmithKline paid nearly $3 billion to settle a Department of Justice lawsuit alleging that the company illegally promoted its drugs for off-label uses. The settlement reportedly covered accusations that GSK urged doctors to prescribe Zofran for morning sickness.

Zofran has been linked to an increased risk of birth defects among babies born to women who take the drug to treat morning sickness, particularly during early pregnancy. A 2013 study found that these children are more likely to suffer a preterm birth and shorter birth length, while a 2014 study found that children exposed to Zofran in utero were more likely to suffer from heart defects, cleft palate defects and other congenital birth defects.


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