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To explore the adverse reactions of risdiplam based on Public Data Open Project of the US Food and Drug Administration (OpenFDA) in order to provide reference for clinical drug safety.
The relevant data of risdiplam were searched and extracted from the OpenFDA database from August 7, 2020 to May 31, 2022. And the report odds ratio (ROR) and proportional report odds ratio (PRR) were applied for signal detection.
A total of 844 adverse event (ADE) reports with risdiplam as a primary suspicious drug were retrieved, and 68 adverse drug reactions (ADR) risk signals were detected, including positional vertigo, decreased oxygen saturation, tachycardia, and accelerated heart rate, which were not labeled in package insert. Top 5 ADE reports were product storage errors, gastrointestinal dysfunction, muscle weakness, diarrhea and weakness. Top 5 ADES in signal strength included diaper dermatitis, positional vertigo, respiratory tract infection virus, product temperature drift, and skin contact exposure.
It is helpful to use real-world data for assessing the potential adverse reactions of risdiplam, suggesting clinicians to monitor specific adverse events and conduct further drug safety evaluations. The signal strength of positional vertigo is high and is not mentioned in the instruction manual, thus it is necessary for clinicians to pay close attention.
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| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |
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