THIS MEDICATION CAN CAUSE HARM TO YOUR BABY:
Fexofenadine should be used with caution if administered in pregnant women or nursing mothers. There is limited safety information from human studies that have looked at the use of fexofenadine during pregnancy, but animal studies indicate that taking fexofenadine during pregnancy may be harmful to the developing baby.
What is fexofenadine?
Fexofenadine is a second generation antihistamine medication that is taken to control allergy symptoms in children and adults. It is currently available as generic and brand name (e.g. Allegra) medications. Fexofenadine is available in tablets, oral disintegrating tablets, and oral suspension and is taken once or twice daily. It is only available by prescription from your doctor.
What is fexofenadine used to treat?
Fexofenadine is used to treat upper respiratory allergies with symptoms including sneezing, runny nose, itchy nose or throat, and watery eyes in adults and children over 2 years of age.
How does fexofenadine work?
Fexofenadine works by preventing histamine from binding to receptors on cells in the respiratory tract, gastrointestinal tract, or blood vessels. Interruption of histamine binding prevents the inflammation and activation of the immune system that causes allergy symptoms.
If I am taking fexofenadine, can it harm my baby?
Fexofenadine should not be used during pregnancy unless the benefits of treatment outweigh the potential risks to the baby. There are limited human studies or case reports that have looked at the safety of this medication in pregnancy. Other antihistamine medications may be recommended during pregnancy. Animal studies show that taking fexofenadine during pregnancy may cause harm to your baby.
The American College of Obstetricians and Gynecologists states first generation antihistamines such as chlorpheniramine or tripelennamine are preferred during the first trimester of pregnancy. Second generation antihistamines including cetirizine or loratadine are considered as alternatives to first generation antihistamines after the first trimester of pregnancy. Alternative antihistamines may be beneficial in pregnant women who fail to respond to or can't tolerate preferred antihistamines.
Evidence from animal studies with fexofenadine:
When given to pregnant rats and rabbits at much larger doses than the maximum recommended human dose, fexofenadine was found to cause reduced fetal weight gain and survival. It was not associated with a higher rate of birth defects.
Evidence for the risks of fexofenadine in human babies:
Case reports and small studies in women taking fexofenadine during the first trimester found no increased risk of birth defects in newborn babies. The National Birth Defects Prevention Study (1997-2003) reviewed 364 cases of birth defects and their association with the use of several different antihistamines. Fexofenadine was not associated with any birth defects in women using the medication during early pregnancy. The Slone Epidemiology Center Birth Defects Study (1998-2010) found no association between antihistamine use during pregnancy and a consistent increase in birth defects.
Bottom line: Fexofenadine should not be used during pregnancy unless preferred antihistamines are not tolerated or are ineffective at maximum doses. There is limited information on the safety of this medication in humans during pregnancy. Animal studies have shown that fexofenadine may be harmful to the developing baby.
If I am taking fexofenadine and become pregnant, what should I do?
If you are taking fexofenadine and become pregnant, you should contact your doctor immediately. Your doctor will determine if your medication is medically necessary, or if it should be discontinued until after the birth of your baby.
If I am taking fexofenadine, can I safely breastfeed my baby?
The American Academy of Pediatrics rates fexofenadine as compatible with breastfeeding, but warns that if breastfeeding moms are taking fexofenadine, either breastfeeding or the medication should be discontinued. Fexofenadine is expected to pass into human breast milk. Human studies have shown that fexofenadine passes into breast milk. If fexofenadine passes into breast milk, it could cause serious effects in the breastfed baby. There is no data on the safety of fexofenadine in breastfed babies. Fexofenadine is a second generation antihistamine that is not associated with as much sleepiness as first generation antihistamines such as diphenhydramine (e.g. Benadryl). The use of antihistamines such as fexofenadine while breastfeeding may be associated with sleepiness, irritability, and jitteriness in breastfed babies. When a woman who is breastfeeding requires an antihistamine, other antihistamines may be preferred. Caution is advised when administering fexofenadine in women who are breastfeeding babies.
Fexofenadine may negatively impact milk production.
Bottom line: In breastfeeding moms who are taking Fexofenadine, caution is advised due to unknown effects on breastfeeding babies.
If I am taking fexofenadine, will it be more difficult to get pregnant?
There have been no studies in men or women that have looked at the effects of fexofenadine on fertility. Studies in rats have identified a dose-related decrease in embryo implantation and post-implantation loss with exposure to fexofenadine 6 mg twice daily.
If I am taking fexofenadine, what should I know?
Fexofenadine is not a preferred antihistamine during pregnancy. There are limited human studies that have looked at the effects of fexofenadine in pregnancy.
In breastfeeding moms who are taking fexofenadine, caution is advised since the effects on the breastfed baby are unknown.
If I am taking any medication, what should I know?
This report provides a summary of available information about the use of fexofenadine during pregnancy and breastfeeding. Content is from the product label unless otherwise indicated.
You may find Pregistry's expert report about allergic rhinitis here, reports about various other health conditions as well as the individual medications used to treat allergies and other conditions here. Additional information can also be found in the resources below.
For more information about fexofenadine during and after pregnancy, contact http://www.womenshealth.gov/ (800-994-9662 [TDD: 888-220-5446]) or check the following link:
U.S. Food and Drug Administration: Allegra Prescribing Information