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Pharmacovigilance. Update Adverse Reactions in Japan (Hydroxyzine hydrochloride, Hydroxyzine pamoate)

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Pharmacovigilance. Update Adverse Reactions in Japan (Hydroxyzine hydrochloride, Hydroxyzine pamoate)

Pharmacovigilance. Update Adverse Reactions in Japan (Hydroxyzine hydrochloride, Hydroxyzine pamoate)

In order to maintain the safety of the patients, Agencies around the world are continuously updating their requirements. As a result of the adverse effects that a drug may have in the user. In this case, Japan published a new requirement in the clinically significant adverse reactions section. The active substance included are Hydroxyzine hydrochloride and Hydozyzine pamoate. PMDA asks for a revision of the package insert of the product following their indications (see below).

Due to reported cases of acute generalized exanthematous pustulosis in patients treated with hydroxyzine hydrochloride or hydroxyzine pamoate. Including Japan and overseas. For example, United States package insert had a revision. Consequently, an investigation result based on the opinions of expert advisors and the available evidence, the MHLW/PMDA concluded that revision of the package insert was necessary.

In the Clinically Significant Adverse Reactions subsection of the Adverse Reactions section, PMDA asks to include the following text: “Acute generalized exanthematous pustulosis: Acute generalized exanthematous pustulosis may occur. Patients should be carefully monitored. If any abnormalities are observed, administration of this drug should be discontinued and appropriate measures should be adopted.”

Likewise, if you want more information about the topic, you can see the Summary of investigation results and Revision of Precautions.

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Pharmacovigilance. Update Adverse Reactions in Japan (Hydroxyzine hydrochloride, Hydroxyzine pamoate)