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22 December 2008 /Side effects and trials
From New Year the Danish Medicines Agency will take over the contact to doctors who report adverse reactions
In the new year, the contact between doctors reporting adverse reactions and the pharmaceutical companies responsible will take place via the Danish Medicines Agency.
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10 December 2008 /Side effects and trials
Conventional antipsychotics may cause increased risk of death in elderly people with dementia
It is known that the so-called atypical antipsychotic agents are assoctiated with an increased risk of death in elderly people with dementia.
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20 November 2008 /Side effects and trials
New information about cardiovascular adverse reactions from the use of NSAID
A Danish study has provided information about the cardiovascular safety of using pain-killing medicinal products of the NSAID type. The study is a well-designed pharmacoepidemiological study based on, among other things, information from the Danish Register of Medicinal Product Statistics, and it was published on 5 November 2008 at the website of the journal Clinical Pharmacology & Therapeutics.
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27 October 2008 /Side effects and trials
Second place isn’t good enough – the Danish Medicines Agency increases its focus on the reporting of adverse drug reactions
Among the European countries, Denmark is only surpassed by France when it comes to gathering the proportionately largest number of reports on side effects from medicine.
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27 October 2008 /Side effects and trials
EMEA recommends to suspend the licence for the weight-loss product Acomplia® across the EU
The European Medicines Agency (EMEA) has recommended that the licence for Acomplia® from the company Sanofi-Aventis be suspended across the EU. The EMEA's Committee for Medicinal Products for Human Use (CHMP) has assessed that the benefits of the rimonabant-containing Acomplia® no longer outweigh its risks.
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30 August 2007 | Updated 06 October 2008 /Side effects and trials
Consumption and adverse reactions to treatment of attention and hyperactivity disorders in children
The consumption of medicinal products for treatment of ADHD (Attention Deficit/Hyperactivity Disorder) in children has increased significantly over the past years.
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30 September 2008 /Side effects and trials
Report all side effects from Gardasil®
From 1 October 2008 and two years onwards, the Danish Medicines Agency implements special monitoring of side effects (adverse reactions) fron the Gardasil® cervical cancer vaccine.
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26 September 2008 /Side effects and trials
EMEA recommends update of the product information for the sclerosis medicine Tysabri®
The EMEA's Committee for Medicinal Products for Human Use (CHMP) has recommended that the product information for the sclerosis medicine Tysabri® (natalizumab) be updated.
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13 August 2008 /Side effects and trials
EMEA assesses incidents of progressive multifocal leukoencephalopathy (PML) in sclerosis patients receiving Tysabri®
The European Medicines Agency (EMEA) has received two reports of progressive multifocal leukoencephalopathy (PML) in patients with relapsing-remitting multiple sclerosis (MS).
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11 August 2008 /Side effects and trials
Antiepileptics and increased risk of suicidal thoughts and behaviour
The European Medicines Agency (EMEA) has concluded that antiepileptics may entail a slight risk of suicidal thoughts and behaviour.
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23 July 2008 /Side effects and trials
Side effects from statins (simvastatin, pravastatin, lovastatin, fluvastatin, atorvastatin, rosuvastatin)
Statins are used to treat high cholesterol. As part of its regular monitoring of adverse reactions, the EU agencies are presently investigating the following types of adverse reactions.
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27 June 2008 /Side effects and trials
EMEA warns against the use of epoetins in cancer patients
The European Medicines Agency (EMEA) recommends that the product information for epoetin-containing medicines be updated with a new warning for their use in cancer patients stating that blood transfusion should be the preferred methods of correcting anaemia in cancer patients.
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26 June 2008 /Side effects and trials
EMEA recommends new warnings and contraindications for ergot-derived dopamine agonists
The European Medicines Agency (EMEA) has recommended updating the product information for ergot-derived dopamine agonists with new warnings and contraindications in relation to the risk of fibrosis.
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26 June 2008 /Side effects and trials
EMEA strengthens warnings and contraindications for etoricoxib-containing medicines
The European Medicines Agency (EMEA) has finalised a review of the benefits and risks of etoricoxib-containing medicines. The EMEA has concluded that these medicines can be used to treat rheumatoid arthritis and ankylosing spondylitis (Bechterew disease), but has recommended that their product information should be updated concerning the risk of cardiovascular side effects.
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12 June 2008 /Side effects and trials
Renewed focus on adverse drug reactions from the use of Champix® (vareniciline)
A report published on 21 May 2008 by the private American non-profit organisation Institute for Safe Medication Practices (ISMP) has spurred a renewed interest in possible adverse drug reactions from the use of Champix® (varenicline), which is a medicinal product for smoking cessation treatment.
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28 April 2008 /Side effects and trials
Tests completed for heparin products on the Danish market
Pfizer has now tested the remaining nine Fragmin® batches which the Danish Medicines Agency instructed Pfizer to withdraw from the market yesterday.
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28 April 2008 /Side effects and trials
EMEA's Committee for Human Medicinal Products reviews heparin issues
The EMEA's Committee for Human Medicinal Products (CHMP) is reviewing issues related to the treatment with and supply of heparin products.
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24 April 2008 /Side effects and trials
Analysis of heparin products on the Danish market
All heparin products on the Danish market have been tested for the impurity oversulfated chondroitin sulfate (OSCS). The products were tested after it came out that the use of heparin products (most of which are produced by the American company Baxter) has caused some serious adverse reactions in the US.
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24 April 2008 /Side effects and trials
Use of angiotensin II receptor antagonists during pregnancy – updated product information
The European Medicines Agency (EMEA) has recommended that the product information of all angiotensin II receptor antangonists authorised via the EU centralised procedure be harmonised, regarding their use during pregnancy.
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22 April 2008 /Side effects and trials
Report on the contrast medium Omniscan®
On 22 February, the Danish Minister for Health and Prevention requested the Danish Medicines Agency to prepare a report on Omniscan®. This report has been submitted to the Ministry of Health and Prevention.
