Share
News
-
23 December 2011 /Side effects and trials
EMA to review benefits and risks of blood pressure medicines containing aliskiren
Yesterday, the European Medicines Agency (EMA) started reviewing the benefits and risks of blood pressure medicines that contain aliskiren. Based on the present knowledge, the Danish Medicines Agency does not find that there is cause to review the patients’ treatment urgently.
-
21 December 2011 /Side effects and trials
EMA confirms a positive benefit-risk balance of medicines containing growth hormone (somatropin)
After completing a review of all available data on medicines containing growth hormone (somatropin), the European Medicines Agency (EMA) confirms that the benefits of these medicines still outweigh their risks.
-
25 November 2011 /Side effects and trials
Atomoxetine (Strattera®) and risk of increased blood pressure and heart rate
In November 2011, the European Pharmacovigilance Working Party (PhVWP) concluded that new knowledge should be communicated about the known risk of increased blood pressure and heart rate associated with the use of atomoxetine, which is authorised for the treatment of ADHD (Attention-Deficit/Hyperactivity Disorder).
-
25 November 2011 /Side effects and trials
Tibolone and potential risk of venous thromboembolism, myocardial infarction, breast cancer and ovarian cancer
The European Pharmacovigilance Working Party (PhVWP) has looked at new data from various epidemiological studies on the connection between the use of tibolone, which is authorised for the treatment of symptoms of oestrogen deficiency due to menopause and for the prevention of osteoporosis, and the risk of thromboembolism, myocardial infarction, breast cancer and ovarian cancer.
-
25 November 2011 /Side effects and trials
Strengthened suspicion about risk of foetal malformations from use of the antiepileptic topiramate (Topimax® etc.)
It is well-known that use of antiepileptics during pregnancy can cause malformations in the foetus. A recent review of data from two birth registers has reinforced the suspicion concerning the antiepileptic topiramate. The review showed that use of topiramate during the first trimester of pregnancy may cause increased risk of cleft lip and palate, hypospadias and malformations in other parts of the body.
-
25 November 2011 | Updated 25 November 2011 /Side effects and trials
New recommendations for escitalopram announced by EMA
In October 2011, the European Pharmacovigilance Working Party, PhVWP, decided that the summaries of product characteristics and package leaflets of medicine containing the antidepressant citalopram must be updated with information on a lower maximum dose. EMA has also reviewed the antidepressant escitalopram and has concluded that the maximum dose of escitalopram should also be reduced.
-
18 November 2011 /Side effects and trials
Pradaxa (dabigatran etexilate) – remember to assess renal function
At a meeting held 17-20 October 2011, the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA), strengthened the instructions for doctors' use of dabigatran etexilate with particular focus on patients with impaired renal function.
-
01 November 2011 | Updated 09 November 2011 /Side effects and trials
Monthly report from the EU Pharmacovigilance Working Party, PhVWP – October 2011
The EU Pharmacovigilance Working Party (PhVWP) convened on 17-19 October 2011. On the meeting's agenda was antiepileptics, citalopram and domperidone.
-
28 October 2011 /Side effects and trials
European Medicines Agency recommends lower dose of citalopram
In October 2011, the European Pharmacovigilance Working Party has concluded to reduce the maximum dose of the antidepressant medicine citalopram. The recommendation follows from a drug trial and adverse reactions showing that citalopram may affect the heart rhythm, especially when given in high doses.
-
25 October 2011 /Side effects and trials
Number of suspected adverse reactions reported to the Danish Medicines Agency for articaine
In 2006, the Danish Medicines Agency examined the risk of nerve damage from the anaesthetics that dentists use for local anaesthesia. The examination was initiated due to a suspicion raised in Denmark that one of the active substances, articaine, caused a greater risk of nerve damage than other substances. We have followed the development since then, and we have decided to review the safety again.
-
24 October 2011 /Side effects and trials
Adverse reaction reports on antidepressants and pregnancy – June to October 2011
On 20 September 2011, the Danish Medicines Agency published an overview report (in Danish) on antidepressants of the SSRI type, the main focus being on safety and the risk of adverse reactions in foetuses and newborns whose mothers had taken an SSRI. In the subsequent period from 14 June 2011 to 9 October 2011, the Danish Medicines Agency has received 12 reports concerning 21 suspected adverse reactions in children/foetuses whose mothers had taken an SSRI.
-
04 October 2011 /Side effects and trials
Monthly report from the EU Pharmacovigilance Working Party, PhVWP – September 2011
The EU Pharmacovigilance Working Party (PhVWP) convened on 19-21 September. On the meeting's agenda was: active substances with a known risk of Stevens-Johnson syndrome and toxic epidermal necrolysis.
-
04 October 2011 /Side effects and trials
Monthly reports from the EU Pharmacovigilance Working Party, PhVWP – June and July 2011
The EU Pharmacovigilance Working Party (PhVWP) convened on 20-22 June and 18- 20 July 2011.
-
27 September 2011 /Side effects and trials
Danish report on treatment with SSRI antidepressants
Based on a debate about the safety of treatment with SSRI antidepressants, the Danish Medicines Agency has drawn up an overview report. The report aims to provide healthcare professionals and others involved in SSRI treatment with an overview of our current knowledge about the consumption of SSRIs and the safety of this type of medicine. The main focus of the report is on the safety of SSRIs and the risk of adverse reactions in foetuses and newborns of mothers who have used SSRI antidepressants.
-
23 September 2011 /Side effects and trials
The European Medicines Agency recommends restricted use of Multaq®
The European Medicines Agency, EMA, recommends limited use of the medicine Multaq®, which is used for cardiac arrhythmia. This is the result of an overall review of the risks and benefits of this medicine carried out by the Committee for Medicinal Products for Human Use, CHMP. The review was initiated in January 2011 due to reports of serious liver damage in patients who had been treated with Multaq®.
-
13 September 2011 /Side effects and trials
Citalopram and the risk of cardiac arrhythmia
The U.S. Food and Drug Administration (FDA) recently issued a warning against using large doses of the antidepressant citalopram. The FDA has reviewed data which shows that doses of citalopram of 60 mg a day may be linked with changes in the heart rate (QT interval prolongation).
-
11 August 2011 /Side effects and trials
Danish Drug Interaction Database expanded significantly
The Danish website interaktionsdatabasen.dk, where you can find information about interactions between various medicines, has been improved significantly. The Drug Interaction Database is in Danish only. Among the improvements is a general overview of how two different categories of medicinal product groups interact (class effect), the hospital pharmacies' SAD products have been included, and finally, you can search on both active substance and product names for herbal remedies as well as vitamins.
-
21 July 2011 /Side effects and trials
Update on Pandemrix® and narcolepsy
As mentioned in the announcement from 30 June, the case about Pandemrix® and narcolepsy was to be re-evaluated by the member states' experts at the meeting in the European Medicines Agency (EMA), this week. The latest evaluation has resulted in the following recommendation: Pandemrix® should not be used in persons under the age of 20 unless there is no seasonal flu vaccine that protects against influenza H1N1. In Denmark, the seasonal flu vaccine will protect against influenza H1N1.
-
21 July 2011 /Side effects and trials
EMA recommends to restrict the use of a particular diabetes medicine
The European Medicines Agency EMA reacts to information stating that diabetics who are treated with the medicine pioglitazone have a slightly increased risk of bladder cancer.
-
21 July 2011 /Side effects and trials
EMA concludes benefits of the smoking cessation product Champix® (varenicline) still outweigh risks
The Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) has assessed a new study that suggests that the smoking cessation product Champix® (varenicline) may be associated with a risk of cardiovascular events.
