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31 January 2012 /Side effects and trials
Older contraceptive pills still pose the lowest risk of blood clots
The Danish Medicines Agency has reviewed the most important literature on contraceptive pills and the risk of blood clots as well as the most recent data on consumption and reported side effects in Denmark. The Danish Medicines Agency therefore encourages doctors to reduce the known risk factors for blood clots by prescribing 2nd generation contraceptive pills as the first choice to the extent possible.
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31 January 2012 /Side effects and trials
New report on long-term treatment of osteoporosis patients with bisphosphonates
In a new report "Long-term treatment of osteoporosis patients with bisphosphonates", the Danish Medicines Agency reviews treatment patterns and evidence of suspected adverse reactions of long-term treatment with bisphosphonates.
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11 January 2012 /Side effects and trials
Monthly report from the EU Pharmacovigilance Working Party, PhVWP – December 2011
The EU Pharmacovigilance Working Party (PhVWP) convened on 12-14 December 2011. Please find an extract of some of the topics discussed.
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04 January 2012 /Side effects and trials
The prescription-only stop smoking products Zyban® and Champix® and reports of possible side effects
In Denmark, you can get smoking cessation medicine both over the counter and on prescription. In total, the Danish Medicines Agency has received reports on possible side effects from 480 persons who used Zyban® or Champix® in the period 2001-2011. Eight of these reports concern deaths. The Danish Medicines Agency assesses that it is highly unlikely or improbable that any of the eight deaths are due to the medicine.
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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.
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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.
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07 December 2011 /Side effects and trials
Improved guidance on the definition of a clinical trial of medicinal products
The Danish Medicines Agency acknowledges that it is often difficult to find out whether or not a trial is to be classified as a clinical trial of medicinal products. We have therefore updated chapter 1 of our Guideline for applications for authorisation of clinical trials of medicinal products in humans and have also included some examples of what is not a clinical trial. Along with the update, we have published information that can help researchers find out whether a trial is a clinical trial of medicinal products or possibly a non-interventional study.
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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).
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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.
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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.
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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.
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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.
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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.
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02 November 2011 /Side effects and trials
Electronic reporting of SUSARs from other EU countries now possible
The Danish Medicines Agency can now receive electronic reports of suspected unexpected serious adverse reactions, also known as SUSARs, from trials in other EU countries. SUSARs that occur in other EU/EEA countries must be reported to the Danish Medicines Agency if the trials have the same protocol (EudraCT number) as in Denmark. The new opportunity of electronic submission applies to precisely these SUSARs.
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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.
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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.
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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.
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12 October 2011 /Side effects and trials
Focus on medicines most frequently involved in serious adverse drug events can improve patient safety
A new study carried out by a working group associated with the Danish Medicines Agency's network "Prevention of Medication Errors" has shown that it is more or less the same groups of medicines that have been involved in the so-called adverse events from the 1970s and up until today. Based on the study, we have drawn up two lists of medicines that appear in high-risk situations – sorted by active substance and medicine group. The Danish Medicines Agency and the working group behind the study hope that these lists can become an important tool in the daily work with risks in the medication process in the health sector.
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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.
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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.
