What are the effects of Clonazepam (Klonopin) during pregnancy?

From the Guidelines

Klonopin (clonazepam) should be avoided during pregnancy unless the benefits clearly outweigh the risks, due to the potential for birth defects and neonatal withdrawal symptoms. According to the study published in Pediatrics 1, benzodiazepines, including clonazepam, can cause neonatal withdrawal signs, which may include irritability, tremors, and hyperactivity. The study also notes that chronic in utero exposure to a drug like clonazepam can lead to permanent phenotypical and/or neurodevelopmental-behavioral abnormalities.

The European Respiratory Journal study 1 provides a summary of the Therapeutic Goods Administration (TGA) and Food and Drug Administration (FDA) categories for drug use during pregnancy, which can help guide the risk-benefit assessment. However, it does not specifically address the use of clonazepam during pregnancy.

Given the potential risks, women with severe anxiety or seizure disorders who require medication during pregnancy should consider alternative treatments with better safety profiles, such as certain SSRIs for anxiety or other anticonvulsants for seizures, under the guidance of their healthcare provider. Non-pharmacological approaches like cognitive behavioral therapy for anxiety should also be considered. The decision to use Klonopin during pregnancy requires careful individual risk-benefit assessment with a healthcare provider, taking into account the potential risks to the fetus and the benefits of treatment for the mother.

Some key points to consider when making this decision include:

• The potential for birth defects, particularly when used in the first trimester
• The risk of neonatal withdrawal symptoms if used late in pregnancy
• The importance of using the lowest effective dose and gradually tapering the medication before delivery to minimize withdrawal effects in the newborn
• The need for careful monitoring and follow-up with a healthcare provider to minimize risks and ensure the best possible outcomes for both the mother and the fetus.

From the FDA Drug Label

There are no adequate and well-controlled studies of clonazepam in pregnant women. Available human data on the risk of teratogenicity are inconclusive Administration of benzodiazepines immediately prior to or during childbirth can result in a syndrome of hypothermia, hypotonia, respiratory depression, and difficulty feeding In addition, infants born to mothers who have taken benzodiazepines during the later stages of pregnancy can develop dependence, and subsequently withdrawal, during the postnatal period. Studies in pregnant animals have shown harmful effects of benzodiazepine medications (including the active ingredient in clonazepam tablets on the developing fetus Children born to mothers receiving benzodiazepine medications including clonazepam tablets late in pregnancy may be at some risk of experiencing breathing problems, feeding problems, hypothermia, and withdrawal symptoms.

The effects of Clonazepam during pregnancy are not well understood, and available human data on the risk of teratogenicity are inconclusive. However, it is known that:

• Administration of benzodiazepines during childbirth can cause problems such as hypothermia, hypotonia, respiratory depression, and difficulty feeding in newborns.
• Infants born to mothers who took benzodiazepines during late pregnancy may develop dependence and subsequent withdrawal symptoms.
• Pregnant animal studies have shown harmful effects of benzodiazepines on the developing fetus.
• Children born to mothers taking benzodiazepines during late pregnancy may experience breathing problems, feeding problems, hypothermia, and withdrawal symptoms. Due to the lack of conclusive human data and potential risks, caution is advised when taking Clonazepam during pregnancy 2 2.

From the Research

Effects of Clonazepam on Pregnancy

• The use of clonazepam during pregnancy has been studied, but the current findings are derived from limited studies of small sample size 3.
• One study found that clonazepam monotherapy did not increase the risk of major malformations in births, but the study was not large enough to determine whether the rate of major malformations is increased in clonazepam-exposed pregnancies 3.
• Another study suggested that the therapeutic value of a given drug, including clonazepam, must be weighed against theoretical adverse effects on the fetus before and after birth 4.
• To minimize the risks of benzodiazepine therapy, including clonazepam, among pregnant women, it is recommended to use drugs with established safety records at the lowest dosage for the shortest possible duration, avoid use during the first trimester, and avoid multidrug regimens 4.

Risks and Considerations

• Clonazepam, like other benzodiazepines, can readily penetrate membranes and exhibit rapid placental transfer with significant fetal uptake of the drug 5.
• The use of benzodiazepines, including clonazepam, during pregnancy may pose a certain risk to the developing fetus, and the potential benefits of the medication must be weighed against the risks for both mother and her unborn child 6.
• High peak concentrations of clonazepam should be avoided by dividing the daily dosage into two or three doses 4.

Comparison with Other Medications

• Compared to other benzodiazepines, such as diazepam and chlordiazepoxide, clonazepam has limited information available about its effects on the developing fetus and on nursing infants 4.
• The safety of clonazepam during pregnancy is not well established, and more information is needed to determine its safety profile 3.