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What Are the Risks of Off-Label Drug Use to Your Child?

Nov 13, 2015 | Firm News, Pregnancy-Related Injuries

Few subjects are more frightening to an expectant mother than that of birth defects. Everyone who becomes pregnant hopes that their child will be perfect. They recognize that every pregnancy carries some risk, but they want to limit those risks. If they knew some drug they were given raised the risk of a birth defect, they may be far less willing to use it.

The drug Zofran has been associated with children who have been born with various birth defects. The drug, used for anti-nausea, and is approved for use with cancer patients who receive chemotherapy. 

The Food and Drug Administration (FDA) does not classify the drug for morning sickness, but it is often given for that as off-label use. Off-label means it is used for some other purpose than what it has received FDA-approval.

The drug’s manufacturer has been penalized by the FDA for $3 billion after it engaged in the unlawful promotion of these unapproved, off-label uses for their drugs. According to recent reports, the drug maker has been sued in almost 200 lawsuits for birth defects related to Zofran use during pregnancies.

Some OB/GYN’s still recommend the drug for cases when pregnant women are suffering from severe nausea. However, given the billions that drug makers earn, all patients should be extremely careful when agreeing to such treatment.

A drug like Zofran should be used as a last resort and only after full and complete disclosure to the potential side effects of the drug, to ensure the expectant mother fully understands the potential risk to her child.

Source: thedailybeast.com, “Is This Anti-Nausea Pill Safe for Pregnant Women?” Samantha Allen, November 4, 2015