The Danish Medicines Agency has published a comprehensive report on the results of its medical cannabis pilot program, covering the period 2021 to 2022. The report discloses key information regarding suspected adverse reactions, consumption trends and profile overall safety of finished cannabis products.
Overview of side effects
During the specified period, the agency received 19 reports of suspected adverse reactions related to finished cannabis products covered by the pilot program. This is notably a significant reduction from the 20 reports received in 2020. The reports were split into 9 cases in 2021 and 10 in 2022, only one of which was classified as a suspected serious adverse reaction.
Despite an increase in the number of prescriptions for finished cannabis products in 2021 and 2022, annual reports of adverse reactions have decreased by half. The Danish Medicines Agency confirms that these reports did not reveal any safety concerns and that no batch-related side effects were 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 of 19) were for suspected non-serious side effects, such as dizziness, stomach pain, anxiety and diarrhea. One report noted a suspected serious side effect, namely substance-induced psychotic disorder attributed to an overdose.
The agency carefully analyzed each report to assess the potential cause-and-effect relationship between the final cannabis product and the reported side effect. It should be noted that all reported side effects were already known for authorized medicines containing medicinal cannabis and no new or changed risks were identified.
Trends in medical cannabis use
Despite the decrease in the number of reports of adverse effects, 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.
Consumption data, detailed below, describes the types and concentrations 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 years.
| Prescribed product | Content | Consumption in 2021 | Consumption in 2022 |
|---|---|---|---|
| Bedrocan “Cangros” | 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 “Cangros” | 140 mg/g THC + <10 mg/g CBD | 157 patients, 771 prescriptions | 165 patients, 863 prescriptions |
| THC oil “Stenocare” | 30 mg/ml THC + <0.1 mg/ml CBD | 119 patients, 207 prescriptions | – |
| Seedmen “Aurora Nordic Cannabis” | 5 mg THC + 0.2 mg CBD | 264 patients, 1065 prescriptions | – (Discontinued from Nov 15, 2021) |
| Bediol “Cangros” | 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 | – | Month of 5 patients, less than 5 prescriptions |
