News about Side effects and product information
Danish Medicines Agency investigates a case of inflammatory condition reported after COVID-19 vaccination
| 26 August 2021 |
In collaboration with the EMA, the Danish Medicines Agency is investigating whether the rare inflammatory condition of MIS-C, previously observed as an aftereffect of COVID-19 infection in children and adolescents, can also occur after vaccination. While no causality with the vaccine has been established, it cannot be excluded either.
New campaign aimed at doctors: High-quality ADR reports make a difference
| 09 July 2021 |
The monitoring of the safety of COVID-19 vaccines over the last months has shown us just how important the reports on suspected side effects from doctors are. A new campaign to promote the quality of ADR reports submitted by doctors sets out to improve the monitoring of medicine safety even further.
New data analysis centre to open at the Danish Medicines Agency
| 08 February 2019 |
The Danish government today announced its decision to support the establishment of a new data analysis centre in the Danish Medicines Agency. The centre is to handle the analysis of large data quantities in the pharmaceutical and medical devices areas and will set new standards for the monitoring of the safety and efficacy of medicines and medical devices after their marketing.
New report on adverse reactions reported with tramadol for pain relief
| 20 December 2018 |
The Danish Medicines Agency has received 830 reports of suspected adverse reactions with tramadol since the medicine was marketed in March 1993. 155 of them describe symptoms of dependence. This follows from a report that has just been published. In 2017, about 265,000 individuals received treatment with tramadol in Denmark.
Small increased risk of certain types of skin cancer associated with the use of hydrochlorothiazide
| 30 October 2018 |
There is a small increased risk of developing basal cell carcinoma and squamous cell carcinoma in long-term use of blood pressure medicine containing hydrochlorothiazide. This follows from a review of new studies and available data undertaken by the European Medicines Agency, EMA.
Medicines of the future in focus at World Economic Forum
| 20 September 2018 |
Medicines of the future is one of the topics being debated at the meeting of the World Economic Forum, which is currently place right now in Tianjin in China. The Danish Medicines Agency is attending.
Contaminated valsartan has so far not caused an increased incidence of cancer cases in Denmark
| 13 September 2018 |
A Danish registry study has examined if the cancer incidence rate is higher among people treated with the blood pressure lowering medicine Valsartan, which due to the risk of contamination was recalled from the market in July 2018. The study concludes that no increased cancer incidence can be seen at present.
New recommendations for use of Xofigo for treatment of prostate cancer which has spread to the bones
| 28 August 2018 |
The EU's Pharmacovigilance Risk Assessment Committee (PRAC) has adopted new recommendations for use of Xofigo for treatment of prostate cancer which has spread to the bones (bone metastases). Xofigo should only be used in symptomatic patients who have had two previous treatments for prostate cancer and who cannot be treated with other medicines.
DKMA Update March 2018
| 28 March 2018 |
In this issue of DKMA Update you can read about evidence; changes to Tramadol’s summary of product characteristics; inspections of the sale of OTC medicines outside pharmacies and much more
Be aware of rare but possible risk of liver injury in medical treatment of fibroids
| 15 February 2018 |
The Danish Medicines Agency recommends doctors not to start any new patients on the medicine Esmya (ulipristal) because of a rare, but possible, risk of developing serious liver injury.
DKMA Update October 2017
| 10 October 2017 |
In this issue of DKMA Update, you can read about the decision to change the dispensing status of a number of opioids, about the new guidelines on medicinal cannabis for doctors, and about the executive order on the import of cannabis products.
New practice for follow-up information on adverse reaction reports
| 29 September 2017 |
The Danish Medicines Agency has introduced a new practice for the processing of pharmaceutical companies' requests for follow-up information on reports of suspected adverse reactions.
E2B acknowledgment format change
| 12 September 2017 |
Companies that use the Danish Medicines Agency's Pharmacovigilance System should be aware that we have changed the MessageFormatRelease value from 2.0 to 1.0.
| 11 September 2017 |
Our newsletter Danish Pharmacovigilance Update changes name to DKMA Update and will from now on contain information about medicinal products in general, patient safety and life science.
Testing the exchange of E2B files
| 16 August 2017 |
Testing the exchange of E2B ICSRs/SUSARs between the Danish Medicines Agency and companies/sponsors must be completed by Friday 29 September 2017.
Adverse reaction reports received from the Danish Patient Compensation Association
| 14 July 2017 |
The marketing authorisation holder of a medicinal product shall not submit reports to the Danish Medicines Agency about any adverse reactions appearing from decisions about compensation for medicinal injuries, which the company has received from the Danish Patient Compensation Association.
Evaluation of a Danish meta-analysis of antidepressants
| 21 June 2017 |
The Danish Medicines Agency has evaluated a Danish meta-analysis made by the Copenhagen Trial Unit on the effects of antidepressants (SSRIs). The analysis attracted extensive media coverage.
Tramadol: It is important that we are informed of side effects
| 13 June 2017 |
Doctors should contact the Danish Medicines Agency if clinical experience shows that the side-effect profile of a medicinal product is not consistent with the summary of product characteristics.
Danish Pharmacovigilance Update, May 2017
| 08 June 2017 |
The May issue of Danish Pharmacovigilance Update.
Danish Pharmacovigilance Update, April 2017
| 22 May 2017 |
The April issue of Danish Pharmacovigilance Update.