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Danish Pharmacovigilance Update Volume, 1 # 2 17 December 2009

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Danish Pharmacovigilance Update Volume, 1 # 2 17 December 2009 Danish Pharmacovigilance Update Volume, 1 # 2 17 December 2009 Updated recommendations for antipsychotics, finasteride, statins and short-acting beta2 agonists The following recommendations are a result of an overall review by the European Pharmacovigilance Working Party, involving an evaluation of adverse reaction data from various sources, such as adverse reaction reports, clinical studies and published literature. The recommendations wil soon be implemented in relevant summaries of product characteristics and package leaflets. Antipsychotics and risk of also been submitted for the 1 mg Short-acting beta2 agonists venous thromboembolism formulation. and risk of myocardial ischaemia Doctors should identify Statins and possible side possible risk factors for venous effects The use of short-acting beta2 thromboembolism (VTE) in patients agonists to inhibit uterine treated with antipsychotics, so that Doctors should discontinue contractions is contraindicated precautionary measures can be treatment with statins for patients in women with pre-existing or taken before and during treatment. who develop interstitial lung with significant risk factors for disease. ischaemic heart disease Finasteride and possible risk of male breast cancer Doctors should also be aware of Doctors should pay special possible side effects such as sleep attention to asthma/COPD patients Doctors should advise patients who disturbance, memory loss, sexual with a severe heart disease if they receive finasteride to report it to disturbances, depression and are treated with short-acting beta2 their doctor if they experience any interstitial pneumopathy. agonists. If heart symptoms get changes in their breast tissue such worse, patients must see their as lumps, pain, gynaecomastia or These new findings have been doctor. nipple discharge. added to the summary of product characteristics and package leaflet Read all the recommendations at: 1 mg finasteride is authorised of statins, but they do not alter the http://www.hma.eu/222.html for the treatment of hair loss in overall positive risk-benefit balance men, while 5 mg finasteride is of statins. authorised for the treatment of prostatic hypertrophy. Most of the adverse reaction reports relate to 5 mg finasteride, but a few have Danish Pharmacovigilance Update - Newsletter from the Danish Medicines Agency Danish Pharmacovigilance Update Pandemrix® update The Danish State Serum Institute has dispensed approx. 1,000,000 vaccine doses. It is estimated that at least 370,000 people have been vaccinated in Denmark, which includes 75,000 who have been given the second dose. Since 4 November, 82 % of adverse reaction reports have been submitted by doctors and other healthcare professionals, while 18 % have been submitted by vaccinated persons. Read the Pandemrix® update at: Side effects The number of adverse reaction reports submitted since 4 November totals from Pandemrix® from 5 to 11 December 2009 467, covering altogether 1496 adverse reactions. Young children may have fever If parents consider it necessary, State whether it is the 1st or after the second dose they can give their child 2nd dose when you report side paracetamol, etc. to reduce fever. effects of Pandemrix® Doctors should advise parents of children in an at-risk group that they Two doses, at three weeks’ interval, The Danish Medicines Agency may develop fever (possibly high are still recommended for children advise doctors to indicate whether fever) after the second dose. New in an at-risk group younger than the suspected adverse reactions data from the manufacturer show three years of age because the relate to the first or second dose. that young children from six months second dose provides even better This may help us assess whether to three years experience more protection against influenza A the two vaccine doses have adverse reactions from the second (H1N1). different safety profiles. dose than from the first dose - in particular fever, soreness at the Read the full announcement at: You can report all suspected injection site, drowsiness, irritability Young children develop good adverse reactions at: and loss of appetite. protection from influenza A vaccine - www.dkma.dk > Pharmacovigilance but may have fever > Report a side effect Give one vaccine dose to: Read the Danish National Board of Doctors have contributed Health's recommendation at: with solid data for the • Patients aged 10 and older The National Board of Health adjusts monitoring of Pandemrix® who belong to an at-risk recommendations on vaccination for group but have a functional influenza A (H1N1) From 4 November to 11 immune system. December 2009, health List of frequently asked professionals accounted for • Pregnant women who questions about influenza A 82 % of all adverse reactions want to be vaccinated, as (H1N1)v reports related to Pandemrix®. pregnancy in itself does not These data have made it lead to a reduced effect of the The Danish Medicines Agency and possible for us to assess vaccination. the National Board of Health update whether the nature and the list of questions/answers about frequency of the side effects Give two vaccine doses to: influenza A (H1N1)v weekly. experienced by the patients correspond to expectations. • Children under the age of 10 You can read all questions and in an at-risk group. answers at: Side effects from Pandemrix® Questions and answers about from 5 to 11 December 2009 • Patients with a weakened vaccination against influenza A immune system. (H1N1) Danish Pharmacovigilance Update - Newsletter from the Danish Medicines Agency Danish Pharmacovigilance Update Side effects in figures Reports by medicinal product group Reports by medicinal product group ( 1 January - 22 November 2009) The graph to the left shows the number of reports from 1 January to 22 November 2009 by therapeutic subgroups. Considering the media coverage and the medicines’ extent of use, the volume of reports for the different groups corresponds to expectations. The group of systemic hormonal preparations have received the most adverse reaction reports. In this group, Eltroxin® accounted for 95 % of the reports, which is probably a result of the widespread media coverage Eltroxin® received when GlaxoSmithKline changed the excipients and thus the formulation. The side effects emerged when patients switched from the old to the new formulation. The group of antiinfectives for systemic use received the second- most reports. Pandemrix® and the HPV vaccine Gardasil® account for 30 % and 40 %, respectively. Both groups have received extensive media attention. All vaccines of the Danish child vaccination programme belong to this group. Medicinal product groups and severity Medicinal product groups and severity ( 1 January - 22 November 2009) The graph to the left shows the distribution of serious and non- serious adverse reaction reports by medicinal product groups. Most of them are non-serious, which is particularly seen for the groups containing Eltroxin® and Gardasil® and Pandemrix®. The groups with the most serious adverse reaction reports are biological medicine and medicines for infections, which comprise vaccines. The group of various medicines contain, among other things, contrast agents such as Omniscan for which reports of nephrogenic systemic fibrosis (NSF) have been submitted. Danish Pharmacovigilance Update - Newsletter from the Danish Medicines Agency Danish Pharmacovigilance Update Four criteria make up a complete side effect report When you report a suspected suspect to have caused the adverse Reporter details adverse reaction to the Danish reaction. Much of the information Medicines Agency, the following that you must provide about the It is important that we receive four essential pieces of medicine is found on the package details about you when you file a information need to be included or in the package leaflet. Make report so that we can contact you if as a minimum: every effort to name the medicine we need further information. Give actually taken by the patient. your full name and provider ID that • The side effect refers to the practice or deparment • The medicine Beware that the medicine is not that you are linked to. • The patient necessarily the one prescribed due • Reporter details. to the rules on generic prescription. If you enter your provider ID, If in doubt, please provide the form will fill out the address The side effect information about the prescribed fields automatically. Finally, you Diagnose the adverse reaction as medicine, which you can see at the must provide your authorisation precisely as possible. If the patient Medicine Profile via www.sundhed. ID, which enables unambiguous has experienced several side dk. identification. effects from the same medicine, describe them all. The patient You can report side effects at: We prefer to receive the patient's www.dkma.dk > Pharmacovigilance The medicine civil registration number, but > Report a side effect In order for us to check and monitor otherwise the patient's sex, date of the safety of medicines, we need to birth/age and initials will suffice. receive as detailed information as You must give at least one of these possible about the medicine you details in your report. Next year it will be easier to report side effects In April 2010, adverse reaction (a co-operative venture between Medicines with stricter reporting will be integrated authorities, organisations reporting requirements in most medical practice and private firms linked to the systems across Denmark. Danish healthcare sector) on
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