Adverse Reactions of Drugs Containing Valeriana and Corvalol: Analysis of Spontaneous Reporting

Abstract. Valerianа officinalis rhizomes whis roots, monocomponent and complex herbal drugs based on Valerianа officinalis, and the drug Corvalol containing chemically synthesized α-bromizovalerianic acid ethyl ester (ethyl bromovalerianate) are OTC drugs and are widely used. At the same time, in the database of drug adverse effects «Pharmacovigilance» AIS Roszdravnadzor from 2009 to 2018, 147 spontaneous reports of adverse reactions were registered when taking Valeriana rhizomes whis roots and Corvalol. The aim of the study was the analisis of spontaneous reporting about adverse reactions when taking Valeriana rhizomes and roots and the multi-component drug Corvalol in the database «Pharmacovigilance» AIS Roszdravnadzor and assessment of their compliance with the information in the instructions for medical use. It was reactions from the nervous system (lethargy, drowsiness, weakness, apathy, headache, dizziness, depression of consciousness, stupor, neurotoxicity, toxic encephalopathy), from the gastrointestinal tract (nausea, bitterness in the mouth, burning of the mucous membrane, belching, heartburn, appetite disorders), cardiovascular system (tachycardia) and allergic reactions (skin itching, skin flushing, rash, maculo-papular rash, urticaria, dermatitis, cheilitis, aphthous stomatitis, angioedema) in the reports. The sedative and anxiolytic effects of the leading biologically active component of rhizomes with valerian roots, valerenic acid, are mediated through modulation of the function of type-γ-aminobutyric acid receptors A. Experimentally confirmed that the mechanism of action of valerenic acid is similar to benzodiazepine drugs, which cause of a number of reported adverse neurological reactions. However, the range of complaints from patients cited in the reports is significantly wider than in the instructions for the medical use of these drugs. There is a need for further monitoring of reports and analysis of already received data and the addition of prescribing information of Valeriana rhizomes whis roots and Corvalol for ensuring safety requirements.

Valeriana officinalis, Corvalol, GABAA-receptor modulators, adverse effect, adverse reaction, pharmacovigilance, drug safety

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