Are Tamiflu and Relenza safe to use in pregnancy? / FDA

FDA’s website provides the following somewhat contradictory information on swine flu drugs in pregnancy: Yes, they are approved, and CDC recommends their use… but No, they have not been studied in pregnant women.

Treatment of Influenza During Pregnancy

The Centers for Disease Control and Prevention (CDC) recommends women in any trimester of their pregnancy who have a suspected or confirmed influenza infection receive prompt antiviral therapy with Tamiflu (oseltamavir) or Relenza (zanamivir).

Are Tamiflu and Relenza safe to use in pregnancy?

Relenza and Tamiflu are both FDA approved for treatment of influenza. Both drugs have been carefully looked at to understand their safety profile in pregnancy and we are continuing to monitor them closely. For a pregnant woman and her developing baby, the benefit of any drug needs to be considered in light of the risks from the drug and the risks from not treating the disease or condition.

Both drugs are designated “Pregnancy Category C,” which means that they have not been studied in pregnant women. However, Pregnancy Category C does NOT mean the drug cannot be used in pregnant women. Pregnant women can and should receive a category C drug when the possible benefits of using the drug are more likely than the possible risk of harm to the woman or her baby.

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