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14 June 2012 /Side effects and trials
Low oestrogen dose in contraceptive pills reduces risk of blood clots
The risk of forming blood clots in brain and heart from the use of contraceptive pills has become smaller as the dose of oestrogen contained in contraceptive pills has been lowered. Moreover, blood clots in brain and heart are generally less frequent than blood clots in legs and lungs, so shows a new Danish study on a cohort of 1.6 million Danish women aged between 15 and 49.
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07 June 2012 /Side effects and trials
Report on clinical trials of medicines in humans notified in 2011
The Danish Health and Medicines Authority has published an annual report on applications for clinical trials of medicines in humans.
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31 May 2012 /Side effects and trials
Monthly report from the EU Pharmacovigilance Working Party, PhVWP – May 2012
The EU Pharmacovigilance Working Party (PhVWP) convened on 21-23 May 2012.
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29 May 2012 /Side effects and trials
Risk of blood clots associated with hormonal contraceptives
A new major Danish registry study has investigated the risk of blood clots in women using different types of hormonal contraceptives. The study concludes, among other things, that women using a vaginal ring (Nuvaring®) or contraceptive patch (Evra®) have the highest risk of blood clots.
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24 May 2012 /Side effects and trials
European Commission publishes guideline concerning the quality of biological investigational medicinal products in clinical trials
The European Commission has published a guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials.
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23 May 2012 /Side effects and trials
Increased risk of cardiac arrest associated with the use of TCA and SSRI antidepressants
A new Danish study has found an increased risk of cardiac arrest associated with treatment with TCAs (tricyclic antidepressants) or SSRIs (selective serotonin reuptake inhibitors). The study found no association between increased risk of cardiac arrest and the use of SNRI antidepressants (serotonin and norepinephrine reuptake inhibitors) or NaSSA antidepressants (noradrenergic and specific serotonergic antidepressants).
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15 May 2012 /Side effects and trials
Pradaxa – consider age and follow dose recommendations
In March, in collaboration with the Thrombosis Centre in Aalborg, the Danish Health and Medicines Authority published an evaluation of all adverse reaction reports in Danish Pharmacovigilance Update for the period 22 August 2011 up to and including 23 February 2012 in connection with a new indication (prevention of apoplexy in patients with non-valvular atrial fibrillation) for Pradaxa® (dabigatran etexilate). With this announcement, we once more want to call attention to the development in consumption, reported adverse reactions, age and dose recommendations.
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10 May 2012 /Side effects and trials
Drug Analysis Prints with data from more than 14,000 side effect reports
In February, the Danish Health and Medicines Authority published the first 14 of approximately 1,000 adverse reactions prints, called Drug Analysis Prints, of suspected adverse drug reactions (ADRs) reported by doctors, patients and relatives. We have now published the rest.
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01 May 2012 /Side effects and trials
Questions and answers from the Clinical Trial Facilitation Group on trial designs and DSUR
The Clinical Trial Facilitation Group (CTFG) has drawn up a Q&A document on specific trial designs and a document on Development Safety Update Report (DSUR). The CTFG was formed in 2004 by the Heads of Medicines Agencies (HMA), one of the purposes being to obtain a more uniform interpretation of the EU regulatory requirements.
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01 May 2012 /Side effects and trials
Monthly report from the EU Pharmacovigilance Working Party, PhVWP – April 2012
The EU Pharmacovigilance Working Party (PhVWP) convened on 16-18 April 2012. Among the topics discussed at the meeting were:
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01 May 2012 /Side effects and trials
Monthly report from the EU Pharmacovigilance Working Party, PhVWP – March 2012
The EU Pharmacovigilance Working Party (PhVWP) convened on 12-14 March 2012. Among the topics discussed at the meeting were:
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25 April 2012 /Side effects and trials
Use of EU register facilitates publication of clinical research
Researchers who author articles based on clinical trial results can now avoid having to publish the same study in two different public registers. They can avoid double-registration because the EU Clinical Trials Register has now been recognised by the World Health Organization (WHO’s International Clinical Trials Registry Platform) as a so-called 'primary registry' like its US counterpart ClinicalTrials.gov.
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23 April 2012 /Side effects and trials
Gilenya (fingolimod) – new recommendations to reduce risk of adverse effects on the heart
The European Medicines Agency has recommended new advice to healthcare professionals to reduce the risk of adverse effects on the heart associated with the use of the multiple sclerosis treatment Gilenya (fingolimod).
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13 April 2012 /Side effects and trials
Risk-adapted assessment of clinical trials of already marketed medicinal products
The Danish Health and Medicines Authority has looked into the possibility of assessing clinical trials of already marketed medicinal products based on risk adaptation. We now offer shorter assessment times for clinical trials where the risk involved for patients is not higher than the risk of exposing the trial participant to standard treatment.
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15 March 2012 | Updated 16 March 2012 /Side effects and trials
New data on antidepressants of the SSRI type and prevalence of malformations in newborns
Data from a large Danish registry study launched by the Danish National Board of Health suggest that the risk of malformations in children is slightly increased in women who were treated in early pregnancy with an antidepressant of the type selective serotonin reuptake inhibitors (SSRIs). The Danish National Board of Health maintains its recommendation that the decision to medically treat depression in pregnant women should be made only in consultation with a specialist in psychiatry and after other non-medical options have been considered.
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01 March 2012 /Side effects and trials
EMA has updated its questions and answers about GCP
In certain types of trial designs, the investigator and patient do not know whether the patient receives a placebo drug (inactive substance) or a medicine containing an active substance. But in some situations, the investigator needs to know what the patient has been given, in which case it should be possible for the investigator to break the blinding. The new question from EMA deals with whether or not the investigator is to contact the sponsor before he or she breaks the blinding for a patient in a trial.
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28 February 2012 /Side effects and trials
Delay in ACKs for adverse reaction reports due to IT maintenance
EMA is performing maintenance of the EudraVigilance database, including the gateway, from 29 February 2012 to 5 March 2012. There will therefore be a delay in the dispatch of acknowledgement messages (ACKs) for adverse reaction reports.
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24 February 2012 /Side effects and trials
The Danish Medicines Agency publishes prints of reported side effects for download
The Danish Medicines Agency has just published its first complete prints of suspected adverse drug reactions from medicines that doctors, patients and others have reported. To begin with, we provide access to the adverse drug reactions reported for 13 selected active substances.
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23 February 2012 /Side effects and trials
Monthly report from the EU Pharmacovigilance Working Party, PhVWP – February 2012
The EU Pharmacovigilance Working Party (PhVWP) convened on 13-15 February 2012. Among the topics discussed at the meeting were Docetaxel actavis and Good Pharmacovigilance Practices (GVP) for the EU.
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20 February 2012 | Updated 21 February 2012 /Side effects and trials
New contraindications and warnings for blood pressure medicines with the substance aliskiren
The European Medicines Agency, EMA, has just finalised a review of the benefits and risks of blood pressure medicines with aliskiren. The review has resulted in new contraindications and warnings for these medicines.
