FDA Says Nasal Allergy Drug Safe in Pregnancy
Rhinocort Aqua Not Shown to Cause Birth Defects
Aug. 26, 2004 -- The FDA has approved the first nasal allergy drug to be used by pregnant women.
The FDA has changed Rhinocort Aqua, a nasal steroid spray used for hay fever, from category C to category B for pregnant women.
This means studies in pregnant women have shown that using Rhinocort Aqua in any trimester does not increase the risk of birth defects, according to an AstraZeneca news release.
All other steroid nasal sprays are rated pregnancy category C, according to AstraZeneca. Category C means the drug should only be given if the potential benefit outweighs the potential risks to the fetus.
Nasal steroid sprays are used on a daily basis to reduce inflammation, sneezing, runny nose, and nasal congestion due to allergies.
Experience in pregnant women has not shown that Rhinocort Aqua increases the risk of birth defects, the company says. Despite adverse effects in animal studies, it would appear that the possibility of harm to the fetus is remote, it adds.
Remote, but not impossible.
"Because studies in humans cannot rule out the possibility of harm, Rhinocort Aqua should be used in pregnancy only if clearly indicated," says the release.
The company says nursing women should use caution in deciding whether to use the nasal spray, since it's not known if its active ingredient, an anti-inflammatory steroid called budesonide, can be passed through breast milk. Similar steroids can be excreted in human breast milk.
Hay fever affects an estimated 6 million U.S. women of childbearing age, says AstraZeneca.