Is Hydroxyzine Safe During Pregnancy?

Hydroxyzine is a medication widely recognized for its antihistamine properties, commonly prescribed to manage various conditions. Its use during pregnancy warrants careful consideration due to the unique physiological changes and potential implications for both the pregnant individual and the developing fetus.

What Hydroxyzine Is Used For

Hydroxyzine functions as a first-generation antihistamine, primarily acting as an H1 receptor antagonist. This mechanism blocks the effects of histamine, a substance in the body that contributes to allergic reactions. Its action also extends to decreasing activity in the brain, which accounts for its sedative effects.

It is used to relieve itching caused by allergic skin reactions, such as chronic urticaria and atopic dermatoses. Hydroxyzine also provides symptomatic relief for anxiety and tension, and can be used as a sedative before and after surgical procedures, including for managing difficulty sleeping.

Hydroxyzine’s Safety During Pregnancy

The safety of hydroxyzine during pregnancy is complex, with medical guidance often recommending caution due to limited human data. Its product label advises against use in pregnant individuals because comprehensive information on its effects is not fully established. Animal studies have shown evidence of developmental toxicity, including structural abnormalities and fetal death, particularly at doses significantly higher than those used in humans. These findings from animal research contribute to the cautious approach.

For instance, studies involving mice, rats, and rhesus monkeys have indicated an increased risk of birth defects or abortions at elevated doses of hydroxyzine. However, human studies, though limited, have not consistently shown these same risks. One study involving over 200 women exposed to hydroxyzine throughout their pregnancy reported no increase in birth defects. Similarly, an analysis of 100 women taking hydroxyzine during pregnancy did not find an increased chance of miscarriage.

Despite some reassuring human data, the manufacturer generally considers hydroxyzine contraindicated in early pregnancy. There have been reports of temporary symptoms in newborns when mothers used hydroxyzine close to delivery. These neonatal symptoms, sometimes described as withdrawal, can include central nervous system depression, jitteriness, clonic movements, and feeding difficulties. For example, two cases of neonatal withdrawal were reported when the mother used hydroxyzine within four weeks of delivery, with one infant experiencing a seizure.

The approach to classifying medication risks in pregnancy has evolved. The U.S. Food and Drug Administration (FDA) replaced its old pregnancy categories (A, B, C, D, X) with the Pregnancy and Lactation Labeling Rule (PLLR). The PLLR provides a more detailed summary of risks and supporting data to assist healthcare providers. Under the PLLR, hydroxyzine’s pregnancy category is now “Not Assigned,” indicating a comprehensive risk summary rather than a letter category.

How Healthcare Providers Assess Use in Pregnancy

When considering hydroxyzine for a pregnant individual, healthcare providers undertake a thorough assessment that balances potential risks and benefits. A primary consideration is the severity of the pregnant person’s symptoms and the potential impact of untreated conditions. For example, severe anxiety or intractable itching could significantly affect maternal health, which in turn might influence fetal well-being.

The specific trimester of pregnancy also plays a role in the assessment. While some animal studies suggest risks primarily in early pregnancy, human data are often limited across all trimesters. Healthcare providers consider the stage of fetal development when a medication might be introduced, as different organ systems develop at various times. Dosage and duration of treatment are also important factors, with providers typically aiming for the lowest effective dose for the shortest possible duration to manage symptoms.

Individualized medical advice is paramount in these situations. Each pregnancy is unique, and a treatment plan that is suitable for one person may not be appropriate for another. Shared decision-making between the patient and their doctor is a central component of this process, ensuring that the pregnant individual understands the available information, potential alternatives, and participates actively in the treatment choice.

Alternative Approaches for Managing Symptoms

Several alternative strategies exist for managing symptoms typically treated with hydroxyzine, especially when medication use is a concern during pregnancy. For anxiety, non-pharmacological approaches are often recommended as a first line. Cognitive behavioral therapy (CBT) can provide effective coping mechanisms and strategies for managing anxious thoughts and behaviors. Relaxation techniques, such as deep breathing exercises, progressive muscle relaxation, and mindfulness practices, can also help reduce anxiety levels.

When addressing itching (pruritus), especially that related to allergic reactions, topical treatments may offer relief without systemic exposure. These can include emollients, corticosteroid creams, or other anti-itch lotions, applied directly to the affected skin. Other antihistamines with more established pregnancy safety profiles might also be considered by a healthcare provider, depending on the specific type and severity of the itching.

For difficulties with sleep, improving sleep hygiene can be highly beneficial. This involves establishing a consistent sleep schedule, creating a comfortable sleep environment, avoiding caffeine and electronics before bedtime, and incorporating a relaxing routine. In some cases, other medications with a more favorable pregnancy safety profile might be considered for insomnia, but any such decision should always be made in close consultation with a healthcare provider to ensure safety and appropriateness.

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