
Azelastine is an antihistamine used to treat allergy symptoms. It is available as a nasal spray (sold as Astelin) and as eye drops (sold as Optivar) to treat itchy eyes due to allergies. While there is no evidence that azelastine makes it harder to get pregnant, there is insufficient information to establish its safety for use in human pregnancy. Animal studies have shown that high oral doses of azelastine can cause adverse effects such as foetal death, growth retardation, and skeletal malformations. However, when used as eye drops, the amount of azelastine absorbed into the body is likely to be small and is not expected to cause harm to the fetus. Nevertheless, caution should be exercised when using azelastine eye drops during pregnancy, and it is important to consult a healthcare provider before starting or stopping any medication during pregnancy.
Characteristics | Values |
---|---|
Brand names | Astelin, Optivar |
Drug type | Antihistamine |
Drug form | Eye drops, nasal spray |
Safety during pregnancy | Should only be used if the potential benefit justifies the potential risk to the fetus |
Pregnancy category (AU TGA) | B3 |
Pregnancy category (US FDA) | C |
Miscarriage risk | No studies have been done |
Birth defect risk | No studies have been done |
Other pregnancy-related problems | No studies have been done |
Child behavior and learning issues | No studies have been done |
Safety during breastfeeding | Likely safe when used in eye drop form |
What You'll Learn
- Azelastine eye drops are generally considered safe during pregnancy
- Animal studies have shown adverse effects on fetuses at high oral doses
- There is no evidence of an increased chance of birth defects in humans
- There is limited data on the effects of azelastine on breastfeeding
- Consult a doctor before using azelastine eye drops while pregnant
Azelastine eye drops are generally considered safe during pregnancy
Allergies are common during pregnancy, and allergic reactions may be stronger than expected due to changes in the mother's immune system. While it is important to be cautious about the substances used during pregnancy, there are safe over-the-counter eye drops for pregnant women.
There is limited data on the effects of azelastine on human pregnancy, and it is not known if azelastine can make it harder to get pregnant. Animal studies have shown that azelastine does not impact female fertility when used orally at levels up to 150 times the maximum recommended human daily intranasal dose in adults.
High oral doses of azelastine in animal studies have shown adverse effects, including embryotoxicity, foetotoxicity, and teratogenicity. However, these doses are much higher than the recommended human ocular dose. The systemic absorption after ocular administration is low, and animal studies using doses similar to those used in humans have not shown an increased chance of birth defects.
While there is insufficient information to establish the safety of azelastine in human pregnancy, local ocular application results in minimal systemic exposure. Therefore, when used as directed, azelastine eye drops are generally considered safe during pregnancy. However, it is always important to consult a healthcare provider before using any medication during pregnancy to weigh the benefits and risks.
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Animal studies have shown adverse effects on fetuses at high oral doses
Animal studies have shown that high oral doses of azelastine can cause adverse effects on fetuses. In mice, azelastine hydrochloride caused embryo-fetal death, malformations (such as cleft palate, short or absent tail, and fused, absent or branched ribs), delayed ossification, and decreased fetal weight. These effects were observed at extremely high doses, approximately 170 times the maximum recommended human daily intranasal dose in adults. Similar effects were seen in rats and rabbits, with malformations, delayed ossification, and decreased fetal weight occurring at even higher doses relative to the recommended human dosage.
It is important to note that these animal studies used oral administration of azelastine, while the eye drops are for local ocular application, resulting in minimal systemic exposure. The systemic absorption after ocular administration is low, with plasma concentration ranging from 0.02 to 0.25 ng/mL. This means that the amount of azelastine entering the bloodstream and reaching the fetus is expected to be very low.
The potential risks of using azelastine eye drops during pregnancy should be weighed against the benefits. The drug has been classified as category B3 in Australia and category C by the US FDA. Category B3 drugs have been taken by a limited number of pregnant women without an increase in the frequency of malformations or other harmful effects on the fetus. On the other hand, category C drugs have shown adverse effects on the fetus in animal studies, but potential benefits may still warrant their use in pregnant women if the potential benefits justify the potential risks.
While there is uncertainty regarding the significance of animal study results in humans, it is always advisable for pregnant women or those planning to become pregnant to consult their healthcare providers before using any medication, including azelastine eye drops.
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There is no evidence of an increased chance of birth defects in humans
Azelastine is an antihistamine used to treat allergy symptoms. It is available as a nasal spray (sold under the brand name Astelin) and as eye drops (Optivar) to treat itchy eyes due to allergies.
There is insufficient information to establish the safety of azelastine in human pregnancy. High oral doses of azelastine have been shown to induce adverse effects in experimental animals, including foetal death, growth retardation, and skeletal malformations. However, animal studies that used doses of azelastine similar to those used in humans have not shown an increased chance of birth defects.
Systemic absorption is low after ocular administration, and the amount of azelastine absorbed is likely to be small. The US FDA pregnancy category for azelastine is C, meaning animal reproduction studies have shown an adverse effect on the foetus, but there are no adequate and well-controlled studies in humans. The AU TGA pregnancy category is B3, indicating that azelastine has been taken by a limited number of pregnant women without an increase in the frequency of malformations or other harmful effects on the foetus.
Therefore, while there is no evidence of an increased chance of birth defects in humans, caution should still be exercised when using azelastine eye drops during pregnancy. It is important to consult a healthcare provider before taking any medication during pregnancy, as they can discuss the benefits and risks of treatment.
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There is limited data on the effects of azelastine on breastfeeding
Azelastine is an antihistamine used to treat allergy symptoms. It is available as a nasal spray (sold as Astelin) and as eye drops (sold as Optivar) to treat itchy eyes due to allergies.
To reduce the amount of azelastine that reaches the breast milk after using eye drops, it is recommended to apply pressure to the tear duct for at least one minute after instillation and to blot any excess solution with a tissue.
Small occasional doses of the azelastine nasal spray are also not expected to cause any adverse effects in breastfed infants. However, larger doses or prolonged use of the nasal spray may cause drowsiness in the infant and lower milk supply, particularly when used with pseudoephedrine or before lactation is well established. Infant rejection of breastfeeding may also occur due to the bitter taste of the drug.
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Consult a doctor before using azelastine eye drops while pregnant
Azelastine is an antihistamine used to treat allergy symptoms. It is available as a nasal spray (sold as Astelin) and as eye drops (sold as Optivar) to treat itchy eyes due to allergies.
While animal studies have shown no impact on female fertility, there is insufficient information to establish the safety of azelastine in human pregnancy. High oral doses of azelastine have been shown to induce adverse effects (foetal death, growth retardation, and skeletal malformation) in experimental animals. Therefore, caution should be exercised when using azelastine eye drops during pregnancy.
If you are pregnant and considering using azelastine eye drops, it is important to consult your doctor first. Your doctor can help you understand the benefits and risks of using this medication during pregnancy. They will consider your individual circumstances and advise you on the best course of action.
Your doctor may recommend that the benefits of treating your allergy symptoms outweigh the potential risks to the fetus. In such cases, they may advise you to proceed with using azelastine eye drops, but under careful supervision and with regular check-ins to ensure your and your baby's well-being.
Additionally, your doctor can provide guidance on alternative treatments or medications that are safer to use during pregnancy. They can also advise you on other precautions to take when using eye drops, such as removing contact lenses beforehand and practising good hygiene to prevent cross-contamination.
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Frequently asked questions
Azelastine is an antihistamine used to treat allergy symptoms. It comes in the form of a nasal spray and eye drops.
There is insufficient information to establish the safety of azelastine during pregnancy. High oral doses of azelastine have been shown to induce adverse effects in animals, but local ocular application results in minimal systemic exposure. Caution should be exercised when using azelastine eye drops during pregnancy.
Studies have not been done to determine if azelastine can affect human fertility. Animal studies have shown no impact on female fertility in rats when azelastine was used orally at levels up to 150 times the maximum recommended human daily intranasal dose in adults.
Studies have not been conducted to determine if azelastine increases the chance of miscarriage. Miscarriage can occur during any pregnancy for a multitude of reasons.
Animal studies using doses of azelastine similar to those used in humans have not shown an increased chance of birth defects. However, there is a lack of human studies in this area.