Medical cannabis: Danish study on effects and uses
The Danish Medicines Agency has published a full report on the results of its medical cannabis pilot program, covering the period from 2021 to 2022. The report discloses key information concerning suspected adverse effects, consumption trends and the overall safety profile of finished cannabis products.
Overview of adverse reactions
During the specified period, the agency received 19 reports of suspected adverse reactions linked to the finished cannabis products covered by the pilot program. This is notably a significant reduction on the 20 reports received in 2020. The reports were divided into 9 cases in 2021 and 10 in 2022, of which only one was classified as a suspected serious adverse reaction.
Despite increase in the number of prescriptions for finished products in 2021 and 2022, annual adverse event reports have halved. The Danish Medicines Agency confirms that these reports have not revealed any safety issues, and that no batch-related side effects have been identified during the period.
The document provides a detailed analysis of reported side effects, classifying them into two categories: serious and non-serious. The majority of reports (18 out of 19) concerned suspected non-serious side effects, such as dizziness, stomach pain, anxiety and diarrhea. One report concerned a suspected serious side effect, namely a substance-induced psychotic disorder attributed to overdose.
The agency carefully analyzed each report to assess the potential causal relationship between the final cannabis product and the reported side effect. It should be noted that all the side effects reported were already known for the authorized medicines containing medical cannabis and that no new or modified risks have been identified.
Medical cannabis consumption trends
Despite the decrease in the number of adverse reaction reports, the report highlights an increase in the consumption of finished cannabis products. In 2021 and 2022, eight finished cannabis products were made available to consumers, leading to an increase in prescriptions. However, these prescriptions were distributed to fewer Danish patients than in 2020.
The relative data detailed below, describe the types and strengths of finished cannabis products, as well as the corresponding number of citizens and prescriptions reimbursed. Indications for prescribing cannabis included neurogenic pain, neuropathic pain, chronic pain and pain, with patients aged 26 to 79.
| Prescribed product | Contents | Consumption in 2021 | Consumption in 2022 |
|---|---|---|---|
| Bedrocan «Canngros» | 220 mg/g THC + <10 mg/g CBD | 296 patients, 2684 prescriptions | 367 patients, 3090 prescriptions |
| Billinol «LGP» | 160 mg/g THC + <2 mg/g CBD | - | 177 patients, 1060 prescriptions |
| Bedica «Canngros» | 140 mg/g THC + <10 mg/g CBD | 157 patients, 771 prescriptions | 165 patients, 863 prescriptions |
| Stenocare« THC Oil» | 30 mg/ml THC + <0.1 mg/ml CBD | 119 patients, 207 prescriptions | - |
| Sedemen «Aurora Nordic Cannabis» | 5 mg THC + 0.2 mg CBD | 264 patients, 1065 prescriptions | - (Discontinued from Nov 15, 2021) |
| Bediol «Canngros» | 63 mg/g THC + 80 mg/g CBD | 227 patients, 1058 prescriptions | 286 patients, 1063 prescriptions |
| Bediol «Scanleaf» | 63 mg/g THC + 80 mg/g CBD | - | 85 patients, 186 prescriptions |
| Stenocare CBD Oil« | <2 mg/ml THC + 20 mg/ml CBD | - | Less than 5 patients, less than 5 prescriptions |
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