Pharmacovigilance on cannabidiol as an antiepileptic agent

Ammendolia, Ilaria; Mannucci, Carmen; Cardia, Luigi; Calapai, Gioacchino; Gangemi, Sebastiano; Esposito, Emanuela; Calapai, Fabrizio

doi:10.3389/fphar.2023.1091978

Cited by 10 publications

(15 citation statements)

References 48 publications

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“…Despite the growing popularity of this substance, a complete safety profile of CBD has not been drawn. However, CBD can produce several adverse effects, as it has been observed in children treated for seizures refractory to other drugs (Ammendolia et al, 2023). Some of these adverse effects include raising in temperature, but also convulsions (Devinsky et al, 2019).…”

Section: Discussionmentioning

confidence: 99%

Pharmacovigilance of unlicensed cannabidiol in European countries

Calapai,

Esposito,

Ammendolia

et al. 2023

Phytotherapy Research

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Cannabidiol (CBD) is a multitarget agent possessing anti‐inflammatory and antioxidant properties. Unlicensed CBD gained public favor for the care of general health and well‐being as well as to get comfort from inflammatory complaints, pain, anxiety, mood, and sleep disorders. Safety profile of unlicensed CBD has been not sufficiently described. For this reason, suspected adverse reactions (SARs) to CBD unlicensed products were analyzed. Serious SARs to unlicensed CBD products in EudraVigilance, a system purchased by the European Medicines Agency, were analyzed for age, sex of the patient, adverse reactions, indication for use, and concomitant drugs. Serious SARs were 18.9% of all adverse events to unlicensed CBD; they were more frequent in men and adult people and, to a less extent, in children (3–11 years). About sex, in EudraVigilance serious Individual Cases Safety Reports of SARs to CBD in men are in the largest number (58.8%) with respect to women. Unlicensed CBD was used in the 38.8% of cases for treatment of epilepsy; more frequent adverse effects were: mental disorders, hepatic disorders, and aggravation of pre‐existing epilepsy. Drugs or substances more frequently associated with SARs were the antiepileptics clobazam and valproic acid, followed by cannabis. Results suggest that precautions and appropriate surveillance of adverse effects should be taken when unlicensed CBD is used.

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Section: Discussionmentioning

confidence: 99%

Pharmacovigilance of unlicensed cannabidiol in European countries

Calapai,

Esposito,

Ammendolia

et al. 2023

Phytotherapy Research

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“…In this data bank, SARs to IL‐23 inhibitors guselkumab, risankizumab, and tildrakizumab are described in individual case safety reports (ICSRs), similar to other drugs. Spontaneous signaling of SARs involves medical events that have been observed following the use of a drug, but are not necessarily caused by the same medicine 8 . In the EudraVigilance system, all ICSRs are signaled by healthcare or nonhealthcare professionals.…”

Section: Methodsmentioning

confidence: 99%

“…Spontaneous signaling of SARs involves medical events that have been observed following the use of a drug, but are not necessarily caused by the same medicine. 8 The primary outcome of interest was the analysis of ICSRs reporting malignancies as SARs related to the IL-23 inhibitors guselkumab, risankizumab, and tildrakizumab in-3 years 2020-2021-2022. The odds ratio, its 95% confidence interval, and sex difference were calculated using reporting odds ratio (ROR) method.…”

Section: Me Thodsmentioning

confidence: 99%

Suspected oncologic adverse reactions associated with interleukin‐23 inhibitors in EudraVigilance: Comparative study and gender distribution

Calapai,

Mannucci,

Cardia

et al. 2023

Pharmacology Res & Perspec

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Psoriasis is a chronic inflammatory skin disease characterized by plaque formation. Interleukin (IL)‐23 is upregulated in psoriatic lesions and is thought to be a major regulator of the Th17 pathway in psoriasis pathogenesis. Three monoclonal antibodies targeting the IL‐23p19 subunit, guselkumab, tildrakizumab, and risankizumab, have been approved for psoriasis therapy. The balance between cytokines IL‐23 and IL‐12 can affect antitumor and pro‐tumor immune activities, and patients with psoriasis may have higher rates of cancer than the general population. Moreover, a chronic inflammatory state typical of psoriasis may induce protumorigenic effects, however, the potential risk of malignancy in patients taking these drugs remains largely unknown. This study investigated the occurrence of malignancies as suspected adverse reactions (SARs) potentially associated with IL‐23 inhibitors by analyzing real‐world data from the European EudraVigilance database. Although indicatory, these real‐world data seem to confirm the potential association between the IL‐23 inhibitors risankizumab and tildrakizumab, and the occurrence of SARs linked to cancer in patients with psoriasis and, according to a gender perspective, they show that this relationship is asymmetrically distributed between women and men, with a clear prevalence of oncologic SARs in men.

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“…CBD has a favorable safety profile in humans [ 18 , 20 ], in rats [ 210 ], and in dogs [ 211 ]. A recent pharmacovigilance study concluded that CBD is a safe compound that causes only rare adverse reactions [ 212 ]. However, like any other drug, it is not innocuous; the adverse effects reported in humans so far could vary in severity and include somnolence, fatigue, gastrointestinal ailments, such as diarrhea, vomiting, and changes in appetite/weight, among others [ 213 ].…”

Section: Therapeutic Evidence Involving Cbdmentioning

confidence: 99%

“…Finally, CBD action on hepatic enzymes needs to be consider since it can modify the pharmacokinetics of other drugs. A pharmacovigilance study concluded that CBD–drug interactions must be highly considered, since CBD is indicated in people with ongoing treatments, some of them as aggressive as chemotherapy [ 212 ].…”

Section: Therapeutic Evidence Involving Cbdmentioning

confidence: 99%

The Polypharmacological Effects of Cannabidiol

et al. 2023

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Cannabidiol (CBD) is a major phytocannabinoid present in Cannabis sativa (Linneo, 1753). This naturally occurring secondary metabolite does not induce intoxication or exhibit the characteristic profile of drugs of abuse from cannabis like Δ9-tetrahydrocannabinol (∆9-THC) does. In contrast to ∆9-THC, our knowledge of the neuro-molecular mechanisms of CBD is limited, and its pharmacology, which appears to be complex, has not yet been fully elucidated. The study of the pharmacological effects of CBD has grown exponentially in recent years, making it necessary to generate frequently updated reports on this important metabolite. In this article, a rationalized integration of the mechanisms of action of CBD on molecular targets and pharmacological implications in animal models and human diseases, such as epilepsy, pain, neuropsychiatric disorders, Alzheimer’s disease, and inflammatory diseases, are presented. We identify around 56 different molecular targets for CBD, including enzymes and ion channels/metabotropic receptors involved in neurologic conditions. Herein, we compiled the knowledge found in the scientific literature on the multiple mechanisms of actions of CBD. The in vitro and in vivo findings are essential for fully understanding the polypharmacological nature of this natural product.

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Pharmacovigilance on cannabidiol as an antiepileptic agent

Cited by 10 publications

References 48 publications

Pharmacovigilance of unlicensed cannabidiol in European countries

Pharmacovigilance of unlicensed cannabidiol in European countries

Suspected oncologic adverse reactions associated with interleukin‐23 inhibitors in EudraVigilance: Comparative study and gender distribution

The Polypharmacological Effects of Cannabidiol

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