Report on suspected side effects reported for medicinal cannabis

10 April 2019

Dizziness, nausea and concentration problems are some of the suspected side effects that have been reported to the Danish Medicines Agency in the first year of the medicinal cannabis pilot programme.

In 2018, the Danish Medicines Agency received a total of 21 reports of suspected side effects from the cannabis products that are in the medicinal cannabis pilot programme. This appears from the Danish Medicines Agency's report on side effects reported for cannabis end-products in the pilot programme (in Danish only).

The report briefly reviews the reported suspected side effects, and it offers the Danish Medicines Agency’s assessments of whether there is a possible causality between the reported symptoms and intake of the cannabis products.

Five reports concern suspected serious side effects, and 16 reports describe suspected non-serious side effects. The majority of the reported suspected side effects are known and described in summaries of product characteristics of authorised cannabis-containing medicinal products. The Danish Medicines Agency assesses that there is a possible link between the cannabis products and these side effects. Other of the reported side effects are considered less likely to be linked to the products.

The Danish Medicines Agency has not identified any signals of safety problems with the cannabis products based on the side effects reported in the period. Nor have the reported suspected side effects given the Danish Medicines Agency any cause to take measures to minimise the risks of the products. 

In 2018, a total of 1211 individuals filled a prescription for at least one cannabis product comprised by the pilot programme.

Doctors are subject to stricter reporting requirements for cannabis products in the pilot programme.

Link

Download the Danish report here (pdf)

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