
Azelastine is an antihistamine commonly used to treat allergy symptoms. It is available as a nasal spray (Astelin) and eye drops (Optivar). While there is limited research on the effects of azelastine during pregnancy, animal studies have shown evidence of fetal harm at high doses. As a result, it is recommended that azelastine be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus. Small doses of azelastine nasal spray are not expected to cause adverse effects in breastfed infants, but larger doses or prolonged use may lead to drowsiness and decreased milk supply.
Characteristics | Values |
---|---|
Safety during pregnancy | Should be used during pregnancy only if the benefit outweighs the risk to the fetus |
FDA pregnancy category | C |
Animal studies | Animal azelastine studies have revealed evidence of fetal harm at oral doses 10 times the clinical study dose |
Teratogenicity | Animal fluticasone studies showed decreased fetal weight with nose-only inhalation, but teratogenicity was not seen at maternally toxic doses less than the MRHDID |
Adequate studies in pregnant women | No |
Safety during breastfeeding | Small occasional doses of azelastine nasal spray would not be expected to cause any adverse effects in breastfed infants |
Larger doses during breastfeeding | May cause drowsiness and other effects in the infant or decrease the milk supply, particularly in combination with a sympathomimetic such as pseudoephedrine or before lactation is well established |
What You'll Learn
- Animal studies have shown evidence of fetal harm at high doses
- Azelastine has been shown to cause developmental toxicity in some animals
- Azelastine may cause drowsiness in infants if used in large doses or for a prolonged period
- Azelastine may decrease milk supply, especially when used with pseudoephedrine
- Infant rejection of the breast may occur due to the bitter taste of azelastine
Animal studies have shown evidence of fetal harm at high doses
Animal studies examining the effects of azelastine during pregnancy have shown evidence of fetal harm at high doses. Specifically, animal studies have revealed evidence of fetal harm when azelastine is administered orally at doses 10 times the clinical study dose. At doses 530 times the maximum recommended human daily intranasal dose, given during organogenesis, azelastine caused developmental toxicities, including structural abnormalities, decreased embryo-fetal survival, and reduced fetal body weight. Similarly, in mice, azelastine hydrochloride caused embryo-fetal death, malformations (such as cleft palate and short or absent tail), delayed ossification, and decreased fetal weight at approximately 170 times the maximum recommended human daily intranasal dose.
In rats, azelastine hydrochloride caused malformations, including oligodactyly and brachydactyly, delayed ossification, and skeletal variations, in the absence of maternal toxicity, at approximately 150 times the maximum recommended human daily intranasal dose. Azelastine hydrochloride also caused embryo-fetal death and decreased fetal weight in rats, particularly when administered at extremely high doses of 340 times the recommended human daily intranasal dose.
Additionally, animal studies in rabbits showed that azelastine hydrochloride caused abortion, delayed ossification, decreased fetal weight, and severe maternal toxicity at approximately 300 times the maximum recommended human daily intranasal dose. These findings highlight the potential risks associated with azelastine during pregnancy, particularly when administered orally or at extremely high doses.
It is important to note that the relevance of these high-dose animal studies to human pregnancy is questionable. The studies conducted in mice, rats, and rabbits used oral administration, which may not accurately represent the effects of intranasal or eye drop administration, the typical routes of administration for azelastine in humans. Furthermore, the doses used in these animal studies were significantly higher than the recommended human daily intranasal dose, which may not be directly comparable to human exposure.
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Azelastine has been shown to cause developmental toxicity in some animals
In mice, azelastine hydrochloride caused embryo-fetal death, malformations (cleft palate, short or absent tail, fused, absent, or branched ribs), delayed ossification, and decreased fetal weight at approximately 170 times the MRHDID in adults. In rats, azelastine hydrochloride caused malformations (oligo- and brachydactylia), delayed ossification, and skeletal variations in the absence of maternal toxicity at approximately 150 times the MRHDID in adults.
Additionally, azelastine hydrochloride caused embryo-fetal death and decreased fetal weight, along with severe maternal toxicity, at approximately 340 times the MRHDID. In rabbits, azelastine hydrochloride induced abortion, delayed ossification, decreased fetal weight, and severe maternal toxicity at approximately 300 times the MRHDID in adults.
It is important to note that these animal studies used extremely high doses of azelastine, and the relevance of these findings to human pregnancy is uncertain. The FDA categorizes azelastine as a category C drug, indicating that animal reproduction studies have shown an adverse effect on the fetus, but the potential benefits may still warrant its use in pregnant women despite the potential risks.
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Azelastine may cause drowsiness in infants if used in large doses or for a prolonged period
Azelastine is an antihistamine commonly used to treat allergy symptoms. It is available as a nasal spray (brand name Astelin) and as eye drops (brand name Optivar). While there is no evidence that azelastine causes harm to fertility or increases the chance of miscarriage, it is important to weigh the benefits of treating allergy symptoms against the risks of untreated illness during pregnancy.
Regarding the safety profile of azelastine during pregnancy, animal studies have shown evidence of fetal harm at high doses. In particular, oral administration of azelastine during organogenesis (the period of embryonic development) resulted in developmental toxicities, including structural abnormalities and decreased embryo-fetal survival and fetal body weight. However, these studies used extremely high doses, and the relevance of these findings to human pregnancy is questionable.
The U.S. Food and Drug Administration (FDA) has classified azelastine as pregnancy category C, indicating that animal reproduction studies have shown an adverse effect on the fetus, but there are no adequate and well-controlled studies in humans. This classification emphasizes that the potential benefits of using azelastine during pregnancy may outweigh the potential risks in certain situations.
When it comes to breastfeeding, small occasional doses of the azelastine nasal spray are generally not expected to cause adverse effects in breastfed infants. However, larger doses or prolonged use of the nasal spray may cause drowsiness in infants. This is because azelastine has a bitter taste, and larger doses may be noticed by the infant, leading to potential breast milk rejection. Additionally, azelastine may decrease milk supply, especially when used with pseudoephedrine or before lactation is well established. Therefore, it is recommended to consult a healthcare provider before using azelastine while breastfeeding, as alternative treatments may be preferred.
In summary, while azelastine may be used during pregnancy if the benefits outweigh the risks, it is important to exercise caution when using azelastine while breastfeeding. Small doses of the nasal spray are generally considered safe, but larger doses or prolonged use may cause drowsiness in infants and potentially decrease milk supply. As always, consulting a healthcare provider before starting or stopping any medication during pregnancy or breastfeeding is essential.
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Azelastine may decrease milk supply, especially when used with pseudoephedrine
Azelastine is an antihistamine commonly used to treat allergy symptoms. It is available as a nasal spray (Astelin) to treat symptoms such as a runny, itchy, and stuffy nose and sneezing. It is also available in eye drop form (Optivar) to treat itchy eyes due to allergies.
Azelastine has not been studied for use with breastfeeding. Small occasional doses of azelastine nasal spray are not expected to cause any adverse effects in breastfed infants. However, larger doses or more prolonged use of the nasal spray may cause drowsiness and other effects in the infant or decrease the milk supply, especially when used with pseudoephedrine or if started before breast milk supply is well established. The baby may also reject breastfeeding due to the bitter taste of the drug.
If you are breastfeeding and are concerned about the effects of azelastine, consult your healthcare provider.
Effects of Azelastine on Milk Supply
Antihistamines in relatively high doses given by injection can decrease basal serum prolactin in non-lactating women and in early postpartum women. However, suckling-induced prolactin secretion is not affected by antihistamine pretreatment of postpartum mothers. It is unclear whether lower oral doses of antihistamines have the same effect on serum prolactin or whether this has any impact on breastfeeding success. The prolactin level in a mother with established lactation may not affect her ability to breastfeed.
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Infant rejection of the breast may occur due to the bitter taste of azelastine
Azelastine is an antihistamine medication used to treat allergy symptoms. It is available as a nasal spray and eye drops. While azelastine has not been studied for use with breastfeeding, small occasional doses of the nasal spray are not expected to cause any adverse effects in breastfed infants. However, larger doses or more prolonged use of the nasal spray may decrease milk supply and cause drowsiness and other effects in the infant.
The bitter taste of azelastine is important to consider when breastfeeding. Infant rejection of the breast may occur due to the bitter taste of azelastine. The bitter taste is the most frequently reported adverse event, with about 20% of people experiencing it. To address this issue, the manufacturer has produced another formulation of azelastine with sucralose to improve the taste. Additionally, correct application of the nasal spray, such as tipping the head forward and avoiding inhaling the medication too deeply, can help reduce the perception of bitterness.
If you are breastfeeding and considering using azelastine, it is important to consult your healthcare provider. They can provide personalized advice and recommendations based on your individual circumstances.
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Frequently asked questions
Azelastine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. There are no adequate and well-controlled studies in pregnant women. Animal studies have revealed evidence of fetal harm at oral doses 10 times the clinical study dose.
Animal studies have shown that azelastine can cause developmental toxicities, including structural abnormalities, decreased embryo-fetal survival, and fetal body weight.
Yes, oral nonsedating antihistamines are preferred alternatives. Some specific alternatives are Desloratadine, Fexofenadine, and Loratadine.
Small occasional doses of azelastine nasal spray are not expected to cause any adverse effects in breastfed infants. However, larger doses or prolonged use may cause drowsiness and other effects in the infant or decrease milk supply.
Studies have not been done in humans to determine if azelastine can make it harder to get pregnant. Animal studies have shown no impact on female fertility.