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18 May 2013 /Side effects and trials
The benefits of acne treatment (Diane® Mite, etc.) still outweigh risks in specific patients
The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) has investigated the safety of medicines containing cyproterone acetate and ethinylestradiol, which are used in the treatment of acne (Diane® Mite, etc.). The Committee concludes that the benefits of this type of medicine outweigh the risks, provided it is used in specific patients and measures are taken to minimise the risk of blood clots.
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03 May 2013 /Side effects and trials
New version of the guidance document Voluntary Harmonisation Procedure for clinical trials
April saw the release of version 3 of the Voluntary Harmonisation Procedure (VHP), a voluntary procedure which makes it possible to obtain a coordinated assessment of an application for a clinical trial that is to take place in several European countries.
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30 April 2013 /Side effects and trials
New European list of medicines under additional monitoring
The European Medicines Agency (EMA) has published a list of medicines that are subject to additional monitoring. From the autumn of 2013, these medicines will display an inverted black triangle in their package leaflet and the summary of product characteristics with information for patients and healthcare professionals.
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29 April 2013 /Side effects and trials
Adverse reactions from non-interventional studies to be reported as 'report from study'
The Danish Health and Medicines Authority advises that adverse reactions from non-interventional studies published in the scientific literature should be reported as 'reports from study'. Also, they should only be reported to us if either the authors of the literature article or the marketing authorisation holder (or both) asses that there is a causal relationship between the drug and the adverse drug reaction.
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11 February 2013 /Side effects and trials
Direct Healthcare Professional Communication is published on the website
The Danish Health and Medicines Authority will in future place the Direct Healthcare Professional Communications (DHPCs) that are sent out in Denmark to doctors and others here on the website.
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31 January 2013 /Side effects and trials
Doctors in Denmark follow the recommendations for contraceptive pills
The French authorities recently asked the Pharmacovigilance Risk Assessment Committee (PRAC) to review the safety of the newer types of contraceptive pills (3rd and 4th generations). This follows the last couple of years' several investigations which have indicated that these pills carry a small increased risk of blood clots compared to the older versions (2nd generation). In Denmark, we have already taken steps to counter this increased risk
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31 January 2013 /Side effects and trials
France removes acne pills (Diane® Mite etc.) from the market
Following a review of effect and risk of blood clots, the French authorities have decided to remove cyproterone/oestrogen-containing medicines from the market within three months.
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04 January 2013 /Side effects and trials
Answers to questions about post-authorisation safety studies
We have updated our questions and answers about clinical trials with further details about the so-called post-authorisation safety studies (PASS studies).
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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.
