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30 June 2011 /Side effects and trials
Swedish study increases suspicion about link between the pandemic vaccine Pandemrix® and the sleep disorder narcolepsy in children and adolescents
The Swedish Medical Products Agency has published the result of an epidemiological study which increases suspicion about a link between the sleep disorder narcolepsy in children and adolescents and vaccination with Pandemrix® against influenza A(H1N1). There are still no known Danish incidents of narcolepsy in children and adolescents vaccinated with Pandemrix.
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29 June 2011 /Side effects and trials
Problems with dispatching acknowledgement messages (ACKs) for adverse reaction reports from comapanies
The Danish Medicines Agency had network problems on Wednesday 15 June 2011. Consequently, a very large number of adverse reaction reports failed in our EudraVigilance Gateway. Unfortunately, as a result of our problems with the gateway, a considerable number of reports have piled up (backlog). Therefore, there will most likely be delays in dispatching ACKs. We hope to straighten out the situation by the end of the weekend.
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24 June 2011 /Side effects and trials
Amendments to the guideline on clinical trials in humans
In the Danish Medicines Agency's Clinical Trials department we have reviewed approx. 30 research-initiated applications for authorisation to conduct medicinal product trials submitted in 2010. The review was conducted to assess the need for improved guidance.
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23 June 2011 /Side effects and trials
Need for further review of the risks related to diabetes medicines
Over the past few days, the European Committee for Medicinal Products for Human Use (CHMP) has fast-tracked the results of a new French study. The study shows a small increased risk of bladder cancer in diabetics treated with pioglitazone-containing diabetes medicines. However, the CHMP could not completely confirm an increased risk. Therefore, the Danish Medicines Agency advises Danes to continue their treatment with pioglitazone (contained in the diabetes medicine Actos®).
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23 June 2011 /Side effects and trials
Errors in the dating and the number of adverse reaction reports
The Danish Medicines Agency had network problems on Wednesday 15 June 2011. Consequently, a very large number of adverse reaction reports failed in our EudraVigilance Gateway.
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20 June 2011 /Side effects and trials
Annual report on the Danish Medicines Agency's activities within the pharmacovigilance area in 2010
In 2010, primarily the Danish Minister for the Interior and Health's action plan to improve monitoring of side effects marked the work in the pharmacovigilance area. The action plan was launched in 2009 in cooperation with the Council for Adverse Drug Reactions and was fully implemented in 2010. The annual report offers an insight into much of the pharmacovigilance work performed by the Danish Medicines Agency in 2010.
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14 June 2011 | Updated 17 June 2011 /Side effects and trials
Risk of venous thromboembolism (blood clots) from use of 4th generation contraceptive pills
Women who use 4th generation contraceptive pills should read and follow the instructions of the package leaflet supplied with the contraceptive pills and contact their own doctor if unsure about the treatment.
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16 June 2011 /Side effects and trials
Problems with dispatching adverse reaction reports and acknowledgement messages (ACK) on 15-16 June
In connection with a clean up of failed adverse reaction reports Thursday morning 16 June 2011, some reports may have been dispatched more than once.
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16 June 2011 /Side effects and trials
Risk of heart malformations in children of mothers treated with an antidepressant of the SSRI type
Epidemiological studies have shown a small increased risk of malformations in the cardiovascular system in newborns of mothers who have taken antidepressants containing fluoxetine or paroxetine in the beginning of pregnancy. In addition, the Danish Medicines Agency has received a few reports of the same type of malformations from treatment with citalopram and sertraline. Physicians are advised to follow the applicable restrictive recommendations and carefully weigh the risks and benefits of using antidepressants during pregnancy and to consider prescribing the medicines in consultation with specialists within the field (psychiatrists and/or obstetricians).
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16 June 2011 /Side effects and trials
Guide to getting started in clinical research
The Danish Ministry of Interior and Health has published a guide to getting started in clinical research, which is intended to make it easier and more attractive to engage in clinical research in Denmark. The guide is in Danish, but an English version is under way, and will be posted here on this page as soon as it is available.
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10 June 2011 | Updated 14 June 2011 /Side effects and trials
Diabetes medicine withdrawn in France while awaiting EU review
Since March 2011, the EU has been engaged in reviewing the benefits and risks of diabetes medicines which contain the substance pioglitazone. Pioglitazone is being investigated due to suspicion of an increased risk of urinary bladder cancer. The French drug regulatory authorities have chosen to temporarily remove diabetes medicines that contain pioglitazone from the market, while we are awaiting the outcome of the EU review. In Denmark, the Danish Medicines Agency is awaiting an early, common EU decision on pioglitazone. Danish patients should not change their treatment at the present time.
