(C-189) Amnesia Associated with Teriparatide Use: Signal Review

Background: Teriparatide injection is a parathyroid hormone analog (PTH 1-34). It is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture. Amnesia is a form of memory loss. There are many types of amnesia, each with different causes. While some types of amnesia are temporary, others can be permanent. A signal of Teriparatide and amnesia was detected, and the Saudi Food and Drug Authority (SFDA) has conducted this safety review based on that.

Objectives: This review aims to evaluate the risk of amnesia in association with Teriparatide use.

Methods: The signal Detection team at SFDA has retrospectively searched the World Health Organization (WHO) database (Vigibase) and the National Pharmacovigilance Center (NPC) database to retrieve all reported cases of Teriparatide and amnesia.

Results: Local Cases: The search in the National Pharmacovigilance Center (NPC) database resulted in one case. It was unassessable due to lack of information.
Global Cases: On August 15th, 2024, a search in the World Health Organization (WHO) database (Vigibase) was conducted to retrieve all reported cases between 2004 and 2024 via a signal detection tool (Vigilyze).The search resulted in 408 Individualized Case Safety Reports (ICSRs). The majority of ICSRs (89%) concern female patients, while (9.8 %) concern male patients. 167 ICSRs were classified as serious. The author applied the WHO causality assessment tool on cases with a completeness score (> 0.8), resulting in seven cases with a probable association, seventeen cases with a possible association, and three with an unlikely association. Seven cases were unassessable due to lack of information.
Data mining: Information Component (IC) value was measured using the method for disproportionality analysis developed by the Uppsala Monitoring Center (UMC). A positive cumulative value (IC = 0.2) for spontaneous reporting suggests that the reported cases of Teriparatide and amnesia have been observed more than expected compared to other medications in the WHO database.

Conclusions: The weighted cumulative evidence identified from the causality assessment of the reported cases is sufficient to support a causal association between Teriparatide and the risk of amnesia. Health regulators and healthcare professionals must be aware of this potential risk, and it is advisable to monitor any signs or symptoms in treated patients.