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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.
