News FAMHP

The new edition of the electronic newsletter "VIG-NEWS" of the federal agency for medicines and health products (famhp) is now available. VIG-NEWS is a selection of recent news of pharmacovigilance from different sources.

The Commission for medicinal products for human use conducted a reassessment of the risk-benefit balance of the mucolytics (acetylcysteine, carbocysteine or bromhexine-containing medicines) and made a new recommendation.

The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) confirms the positive benefit / risk balance of Diane 35 and generic medicines which contain cyproterone acetate and ethinyl estradiol for a specific group of patients and recommends measures to reduce the risk of thromboembolic events.

Beginning in 2013, the federal agency for medicines and health products (famhp) initiated a procedure to can possibly put under prescription the domperidone-containing medicines. Based on the evaluation of data submitted by the relevant companies and the various hearings, the Committee for Medicinal Products for Human Use of the famhp, during its meeting of April 2013, issued a final opinion on the delivery status (under prescription or not) of domperidone-containing medicines.

At its meeting from 8th to 11th April 2013 the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) formulated and sent to the Coordination Group for Mutual Recognition and Decentralized procedures - human (CMDh) the recommendation to suspend the marketing authorization of tetrazepam-containing medicines. A previous statement about it was published on our website on 15th April. The CMDh, which met on 22nd to 24th April 2013, confirms the position of the PRAC.

The famhp is launching on 29th April 2013 an awareness campaign, "MEDICINES AND CHILDREN: ATTENTION, A MEDICINE IS NOT A SWEET! " and it offers some tips to help the proper use of medicines in children. On this occasion three brochures to assist the public in determining when and how to give a medicine to a child are being distributed through doctors' and pediatricians’ surgeries, pharmacies and also during ONE and Kind en Gezin consultations. They are also available and downloadable from the website www.médicamentsetenfants.be.

Following the release of 19th March 2012 concerning medicines against cough and colds in children, the famhp reminds people about the recommendations issued in this regard. These apply from 1st May 2013.

The routine reassessment of the risk-benefit balance of Protelos has shown an increased risk of cardiac complications, including myocardial infarction, the Pharmacovigilance Risk Assessment Committee (PRAC), which is the committee for the evaluation of risks in pharmacovigilance of the European Medicines Agency (EMA) recommends restricting the use of Protelos (strontium ranelate) used in the treatment of osteoporosis.

The Pharmacovigilance Risk Assessment Committee (PRAC), which is the Committee for Risk Assessment for pharmacovigilance in the European Medicines Agency (EMA) has reviewed the data available on tetrazepam due to reports of rare but serious skin reactions.

The federal agency for medicines and health products (famhp) will soon launch a first satisfaction survey to assess the quality of its services and products. The results of this will be communicated at the end of 2013 and will be used to improve the delivery of FAMHP services.