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16 November 2012 | Updated 16 November 2012 /Side effects and trials
21 December is final date for submission of clinical trial applications in 2012
The Danish Health and Medicines Authority is closed between Christmas and New Year. Therefore, applications for authorisation of clinical trials in 2012 must reach us by 21 December 2012. All applications that we receive after this date will be considered received on 2 January 2013.
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05 November 2012 /Side effects and trials
European Medicines Agency has started review of codeine-containing medicines
On 3 October 2012, the European Medicines Agency (EMA) started a review of codeine-containing medicines. Codeine-containing medicines are used for pain relief in adults and children. Codeine is to a limited degree converted into morphine in the body. It is well-known that some patients convert codeine to morphine at a faster rate than others, resulting in higher than normal levels of morphine in their blood. This may cause side effects such as breathing difficulties.
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19 October 2012 /Side effects and trials
The Danish Health and Medicines Authority maintains influenza vaccine recommendation
The European Medicines Agency, EMA, has reviewed a hypothesis on Pandemrix® and the development of sleep attacks (narcolepsy). Overall, EMA assesses that there are no grounds for concerns regarding Pandemrix® and other vaccines, including influenza vaccines.
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19 October 2012 /Side effects and trials
Benefits of NSAIDs still outweigh risks - but diclofenac may be associated with a small increased risk of side effects
In October 2011, the Committee for Medicinal Products for Human Use (CHMP) decided to review the newest data on cardiovascular side effects from analgesics (painkillers) of the NSAID type. The conclusions are now available, and they confirm the previous conclusions from 2005 and 2006 that the benefits of NSAIDs still outweigh the risks.
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15 October 2012 /Side effects and trials
The Danish Health and Medicines Authority still recommends influenza vaccine
The Danish Health and Medicines Authority still recommends using the Fluarix® seasonal flu vaccine for people who are in a risk group.
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28 September 2012 /Side effects and trials
Doctors in Denmark follow new recommendations for contraceptive pills
In early 2012, the Danish Health and Medicines Authority recommended doctors to generally prescribe the older type of contraceptive pills (2nd generation pills) because these pills pose the lowest risk of blood clots. In a follow-up report, the Danish Health and Medicines Authority has now reviewed the latest scientific articles as well as the consumption trends and reported side effects for contraceptive pills prescribed in Denmark.
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27 July 2012 /Side effects and trials
Monthly report from the EU Pharmacovigilance Working Party, PhVWP – July 2012
The EU Pharmacovigilance Working Party (PhVWP) convened on 16-18 July 2012.
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25 July 2012 /Side effects and trials
Sun, heat and medicine
Various medicines can make your skin more sensitive to sunlight (photosensitivity), and it concerns both medicines in tablet form and other forms, such as creams. You should therefore protect yourself from the sun by wearing clothes, a hat or by using a good sunscreen if you take medicine that makes your skin more sensitive to light.
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05 July 2012 /Side effects and trials
Monthly report from the EU Pharmacovigilance Working Party, PhVWP – June 2012
The EU Pharmacovigilance Working Party (PhVWP) convened on 18-20 June 2012.
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03 July 2012 /Side effects and trials
New study on treatment with HES (hydroxyethyl starch) in patients with severe sepsis
A new Danish study published in the New England Journal of Medicine has investigated HES used as a plasma substitute in patients with severe sepsis. The study followed 800 patients from intensive care units in Denmark, Iceland, Norway and Finland over a two-year period. The conclusions of the study suggest that HES has a less favourable safety profile than Ringer's acetate used as plasma substitutes in patients with severe sepsis.
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19 June 2012 /Side effects and trials
European Medicines Agency assesses risk of the arthritis medicine diclofenac
In response to recent days' debate about the safety of the arthritis medicine diclofenac, the Danish Health and Medicines Authority urges doctors to carefully follow the restrictions and precautions for use that are already described in the medicine's summary of product characteristics and on the Danish website medicin.dk.
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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.
