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International Journal of Drug Development and Research

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Hydrochlorothiazide Associated Malignant Melanoma: Pharmacovigilance Signal Review

Proceedings of Formulations 2021 & Pharmacovigilance 2021
September 15-16, 2021 WEBINAR

Abdulrahman S Almutairi

King Saud University - Saudi Arabia

Posters & Accepted Abstracts: Int J Drug Dev & Res

Abstract:

Hydrochlorothiazide (HCTZ) is a diuretic and antihypertensive. The medication has a place with a class of diuretics called thiazides diuretics. Malignant Melanoma is the most serious type of skin malignancy, creates in the cells (melanocytes) that produce melanin. The reason for this review is to assess the risk of Malignant Melanoma related to Hydrochlorothiazide use and to propose regulatory recommendations whenever required. On Aug 15, 2021, we performed a signal review utilizing World Health Organization (WHO) VigiBase, with literature screening to recover all related information to assess the causality between Malignant Melanoma and Hydrochlorothiazide use. Causality assessment was done according to the WHO-UMC system for standardized case causality assessment. The disproportionality of the observed and the expected reporting rate for the HCTZ/Malignant Melanoma pair is estimated using the information component (IC). Positive IC values reflect higher statistical association while negative values indicate less statistical association. The review resulted in 4 Individual Case Safety Reports (ICSRs). Out of four assessable ICSRs, two cases revealed probable association, and one case revealed a possible association between HCTZ use and risk of Malignant Melanoma. IC value of (-1) revealed a negative statistical association. The weighted cumulative evidence identified from cases is sufficient to validate and suggest a causal association between HCTZ and Malignant Melanoma. Therefore, health care professionals should be aware of this potential risk and may consider monitoring any signs or symptoms of Malignant Melanoma in patients treated with HCTZ.

Biography :

Abdulrahman S Almutairi has expertise in the delivery of quality pharmaceutical services within Tertiary Educational Clinical Setting. Over an experience extending for more than 4 years, he was involved in direct patient care practices and medication therapy management (MTM). As an adjunct practice obligation, he was part of the institutional pharmacovigilance system and spontaneous reporting of adverse drug reactions. Currently, he is focusing on sharing and publishing data related to the safety, efficacy, and accessibility of medicines.