Azelastine Hcl Nasal Spray: Safe During Pregnancy?

Azelastine is an antihistamine used to treat allergy symptoms such as a runny, itchy, and stuffy nose, as well as sneezing. It is available as a nasal spray (Astelin) and eye drops (Optivar). While there is limited research on the safety of azelastine during pregnancy, animal studies have shown evidence of fetal harm at high doses. The U.S. Food and Drug Administration (FDA) has placed azelastine in pregnancy category C, indicating that the risk to the pregnant woman or fetus cannot be ruled out. Therefore, azelastine nasal spray should only be used during pregnancy if the potential benefits outweigh the potential risks to the fetus.

Azelastine is an antihistamine used to treat allergy symptoms

Azelastine nasal spray is typically sprayed once or twice a day into each nostril. It is important to follow the directions on the prescription label and use the spray exactly as directed. Azelastine eye drops are also usually administered once or twice a day.

Azelastine is generally well-tolerated, but some side effects may include a bitter taste in the mouth, drowsiness, tiredness, nasal discomfort, sneezing, cough, nose bleeds, dry mouth, headache, and red eyes. Serious allergic reactions are rare but may include rash, itching, swelling, severe dizziness, and trouble breathing.

Regarding pregnancy, there are no well-controlled studies in pregnant women. Animal studies have shown evidence of fetal harm at high doses. Therefore, azelastine nasal spray should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is important to consult a healthcare provider before starting or stopping any medication during pregnancy.

Animal studies have shown evidence of fetal harm at high doses

Another study found that 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 in mice at approximately 170 times the MRHDID in adults. In rats, azelastine hydrochloride caused malformations, delayed ossification, and skeletal variations at approximately 150 times the MRHDID. Similarly, in rabbits, azelastine hydrochloride caused abortion, delayed ossification, decreased fetal weight, and severe maternal toxicity at approximately 300 times the MRHDID.

It is important to note that these studies used extremely high doses of azelastine, far exceeding the recommended human daily intranasal dose. At 10 times the normal human dose, no pregnancy or fetal side effects were observed. While animal studies provide valuable information, the effects of azelastine on human pregnancy may differ and require further well-controlled studies in pregnant women.

Healthcare providers must carefully weigh the potential benefits against the potential risks to the fetus when considering the use of azelastine during pregnancy. Pregnant women currently taking azelastine should consult their allergist, prescribing physician, or obstetrician to determine if their treatment protocol needs adjustment during pregnancy.

There are no adequate studies on the effects of azelastine on pregnant women

Azelastine is an antihistamine used to treat allergy symptoms. It is available as a nasal spray (Astelin) and as eye drops (Optivar). While it is important to consult a healthcare provider before starting or stopping any medication during pregnancy, there are no adequate and well-controlled studies on the effects of azelastine on pregnant women.

Animal studies have been conducted to understand the potential impact of azelastine on pregnancy. In studies where azelastine was administered orally, evidence of fetal harm was observed at doses 10 times the clinical study dose. Specifically, during organogenesis, doses 530 times the maximum recommended human daily intranasal dose resulted in developmental toxicities, including structural abnormalities, decreased embryo-fetal survival, and reduced fetal body weight. However, the relevance of these findings at such high doses is questionable.

In studies with 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 at extremely high doses—approximately 170 times the maximum recommended human daily intranasal dose. Similar effects were observed in rats and rabbits at even higher doses. However, it is important to note that these studies involved oral administration of azelastine, rather than the intranasal route typically used in humans.

The U.S. Food and Drug Administration (FDA) has classified azelastine as a pregnancy category C drug. This means that while animal reproduction studies have shown an adverse effect on the fetus, the potential benefits of using the drug in pregnant women may outweigh the potential risks in certain cases. Therefore, azelastine nasal spray should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Azelastine should be used during pregnancy only if the benefits outweigh the risks

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, as well as sneezing. It is also available in eye drop form (Optivar) to treat itchy eyes due to allergies.

When it comes to pregnancy, it is important to carefully consider the use of any medication, including azelastine. While studies in animals have shown evidence of fetal harm at very high doses, there are no well-controlled studies in pregnant women. In animal studies, azelastine hydrochloride caused developmental toxicity, including embryo-fetal death, malformations, delayed ossification, and decreased fetal weight at extremely high doses. However, it is important to note that these doses were much higher than the recommended human daily intranasal dose.

The U.S. Food and Drug Administration (FDA) has placed azelastine in pregnancy category C, indicating that there may be concerns about its use during pregnancy. This category means that animal reproduction studies have shown an adverse effect on the fetus, but there are no adequate studies in humans. Despite the potential risks, the benefits of using azelastine during pregnancy may outweigh them in certain situations.

It is crucial for pregnant women or those planning to become pregnant to consult their healthcare providers before taking any medication, including azelastine. Healthcare providers can help weigh the benefits of treating allergy symptoms against the potential risks to the fetus. They can also provide personalized advice and recommendations based on an individual's medical history and specific circumstances.

In summary, while azelastine may be used during pregnancy if the benefits outweigh the risks, it is important to closely monitor its use and always consult a healthcare provider before starting or stopping any medication during pregnancy.

Small doses of azelastine nasal spray are not expected to harm breastfed infants

Azelastine is an antihistamine used to treat allergy symptoms. It is available as a nasal spray (Astelin) and eye drops (Optivar). While there is limited research on the safety of azelastine during breastfeeding, small doses of the nasal spray are not expected to harm breastfed infants.

When used as directed for a few days, azelastine nasal spray is unlikely to cause adverse effects in breastfed infants. However, prolonged use or larger doses may cause drowsiness in the infant and lower milk supply, especially when used with pseudoephedrine or before lactation is well established. The bitter taste of azelastine may also cause the baby to reject breastfeeding.

It is important to note that azelastine has not been extensively studied for use during breastfeeding. The existing research suggests that when used as eye drops, the amount of azelastine absorbed is likely to be small and unlikely to cause problems in breastfed infants.

To minimise the potential risks, breastfeeding mothers may consider using alternative forms of azelastine, such as eye drops, or opting for oral, non-sedating antihistamines. It is always recommended to consult a healthcare provider before starting or stopping any medication during pregnancy or breastfeeding.

Overall, while small doses of azelastine nasal spray are not expected to harm breastfed infants, it is important for breastfeeding mothers to be aware of the potential risks and consult their healthcare provider for personalised advice and recommendations.

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