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29 March 2011 /Side effects and trials
Acknowledgement Message (ACK) for receipt of an adverse reaction report
The Danish Medicines Agency's new pharmacovigilance system now dispatches ACKs in batch runs. That is why you will no longer receive an ACK immediately after you have submitted an adverse reaction report to the Danish Medicines Agency.
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29 March 2011 /Side effects and trials
Swedish study increases suspicion about link between Pandemrix® (the pandemic vaccine) and the sleep disorder narcolepsy in children and adolescents
A recently completed Swedish registry study indicates that children and adolescents under the age of 20 have a four times higher risk of developing the sleep disorder narcolepsy if they have received the influenza vaccine Pandemrix® compared to those who are not vaccinated. The results from this study are in line with the results of a similar Finnish study.
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16 March 2011 /Side effects and trials
Solutions to problems with EudraCT version 8
After the upgrade to EudraCT version 8, the Danish Medicines Agency has received increasing reports of problems with making changes to already saved XML files. Please find solutions to the problems here.
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14 March 2011 | Updated 14 March 2011 /Side effects and trials
Reports of serious side effects in Japan from the childhood vaccines Prevenar (PCV7)® and Act-Hib®
The marketing authorisations for the vaccines Prevenar (PCV7)® and Act-Hib® have been temporarily suspended in Japan after four deaths among children. None of the lots/batches of the vaccines (Prevenar (PCV7)® or Act-Hib®) used in Japan have been used in Denmark. The Danish Medicines Agency assesses that no further actions are required in Denmark, but will be watching the situation in Japan closely.
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14 March 2011 /Side effects and trials
Reports of serious side effects in France from the childhood vaccine Prevenar13®
The French drug regulatory authorities report of three cases of crib death after vaccination with Prevenar13®. There are no reports of deaths in Denmark that can be related to Prevenar13®. The Danish Medicines Agency assesses that no further actions are required in Denmark, but it will be watching the situation in France closely.
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14 March 2011 /Side effects and trials
Data on deaths or serious side effects in newborns from use of antidepressants (SSRIs)
On 1 March 20111, we published information about two cases of neonatal death in infants whose mothers had been treated with fluoxetine during pregnancy. Since then, we have performed an extended search for adverse drug reaction (side effect) data for all antidepressants of the SSRI type and also for all cases of abortions. Data show a further two cases of neonatal death as well as 12 reports of intra-uterine death (foetal death) or abortions. Even though the risk is small, serious adverse reactions may occur in the foetus and the newborn child if pregnant women are treated with an antidepressant of the SSRI type. The risk should, however, be weighed against the beneficial effect of SSRIs for pregnant women who suffer from a serious disorder requiring treatment.
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11 March 2011 /Side effects and trials
Changes in EudraCT version 8
With the update of EudraCT from version 7 to version 8, several changes have been made to the underlying structure.
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04 March 2011 /Side effects and trials
EudraCT portal unavailable 3 – 10 March 2011
The EudraCT website will be unavailable from Thursday 3 March 2011 to Thursday 10 March 2011 due to the rollout of EudraCT version 8.
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01 March 2011 /Side effects and trials
Risk of death or serious side effects in newborns following exposure to antidepressants (fluoxetine and other SSRIs)
On 27 February 2011, several Danish media addressed the side effects from the antidepressant fluoxetine including death in newborns whose mothers were treated with fluoxetine.
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01 March 2011 /Side effects and trials
Consultation on the revision of the Clinical Trials Directive 2001/20/EC
The European Commission has submitted a document on the revision of the Directive 2001/20/EC on good clinical practice etc.
