Is topical azelastine (antihistamine) safe as eye drops during the second trimester of pregnancy?

From the Guidelines

Topical azelastine eye drops can be considered safe for use during the second trimester of pregnancy when clearly needed, as the amount of medication absorbed systemically is minimal. Azelastine is a second-generation antihistamine, and according to the study by 1, second-generation antihistamines have been found to have excellent safety records and do not show a significant increase in congenital malformations when used during pregnancy. Although the study notes that there are limited data on azelastine specifically, the general safety profile of second-generation antihistamines can be applied to azelastine.

When using topical azelastine eye drops, it is essential to follow the recommended dosage and administration instructions, typically 1 drop in each affected eye twice daily. This minimizes the amount of medication absorbed into the bloodstream, reducing potential risks to the developing fetus. As with any medication during pregnancy, it is crucial to weigh the benefits against the potential risks and consider alternative treatments with more established safety profiles if possible.

Some key points to consider when using topical azelastine eye drops during pregnancy include:

• The medication should only be used when clearly needed and under the guidance of a healthcare provider.
• Non-medication approaches, such as avoiding allergens, using artificial tears, and applying cold compresses, should be tried first to manage eye allergy symptoms.
• Regular monitoring and follow-up with a healthcare provider are necessary to ensure the safe use of topical azelastine eye drops during pregnancy.
• The benefits and potential risks of using topical azelastine eye drops should be discussed with a healthcare provider, taking into account individual circumstances and medical history, as noted in the study by 1.

From the FDA Drug Label

Pregnancy Teratogenic Effects: Pregnancy Category C Azelastine hydrochloride has been shown to be embryotoxic, fetotoxic, and teratogenic (external and skeletal abnormalities) in mice at an oral dose of 68. 6 mg/kg/day (57,000 times the recommended ocular human use level). At an oral dose of 30 mg/kg/day (25,000 times the recommended ocular human use level), delayed ossification (undeveloped metacarpus) and the incidence of 14th rib were increased in rats. At 68. 6 mg/kg/day (57,000 times the maximum recommended ocular human use level) azelastine hydrochloride caused resorption and fetotoxic effects in rats. The relevance to humans of these skeletal findings noted at only high drug exposure levels is unknown. There are no adequate and well-controlled studies in pregnant women Azelastine hydrochloride ophthalmic solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

The use of topical azelastine as eye drops in pregnancy, specifically in the 2nd trimester, is not directly addressed in the provided drug label. However, the label does mention that azelastine hydrochloride ophthalmic solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Given the lack of specific information regarding the 2nd trimester and the potential risks associated with azelastine, a conservative clinical decision would be to exercise caution when considering its use in pregnant women, including those in the 2nd trimester, and to carefully weigh the potential benefits against the potential risks to the fetus 2. Key considerations include:

• The potential for embryotoxic, fetotoxic, and teratogenic effects at high doses
• The lack of adequate and well-controlled studies in pregnant women
• The need to carefully evaluate the potential benefit versus the potential risk to the fetus.

From the Research

Safety of Topical Azelastine in Pregnancy

There are no research papers provided that directly address the safety of topical azelastine as eye drops in pregnancy, specifically in the 2nd trimester.

Available Information on Azelastine

• The studies provided focus on the efficacy and tolerability of azelastine in treating allergic conjunctivitis 3, 4, 5, 6.
• Azelastine has been shown to be effective in reducing symptoms of allergic conjunctivitis, such as itching and conjunctival redness 5.
• The onset of action of azelastine is within 3 minutes, and its duration of effect is at least 8 to 10 hours 5.
• Azelastine has been compared to other topical antihistamine/mast cell stabilizers, such as olopatadine and ketotifen, in terms of ocular comfort and drying effects 6.

Limitations

• None of the provided studies specifically address the safety of azelastine in pregnancy.
• There is no information available on the potential risks or benefits of using azelastine during pregnancy, particularly in the 2nd trimester.