News FAMHP

A survey has been launched on the Internet across Europel to gather information on the factors that influence the prescribing practices of veterinarians concerning antimicrobials. Practicing veterinary surgeons are encouraged to complete this survey which closes on April 15th 2012.

The European Medicines Agency confirms that the benefit / risk balance of strontium ranelate (PROTELOS in Belgium) remains positive. It recommends, however, that this medicine be contra-indicated in immobilised patients or patients with venous thromboembolism. It also updated the warnings regarding serious skin reactions.

The Committee for Medicinal Products for Human Use has reassessed the risk-benefit balance of medicines used in children against cough and cold, namely antitussives, expectorants and topical nasal decongestants. Based on the advice of this commission, the Federal Agency for Medicines and Health Products (FAMHP) has taken certain measures concerning these medicines.

New recommendations regarding the use of metoclopramide were issued, at the European level, following the observation of an increased frequency of adverse neurological events in children under 18 years: medicines containing metoclopramide are contraindicated in children less than one year and not recommended beyond one year and up to 18 years.

The FAMHP warns against the sale in home shopping and / or on the internet of products illegally presented as medicinal products - The Abexine Gel product offering.

The FAMHP publishes information on advice committees that are established within it. Currently available information concerns the mission, the composition, the house rules and the agenda of the meetings of six committees. This information shall be supplemented regularly by the public agendas and minutes of the meetings of these committees as well as information on other committees set up within the FAMHP.

The new edition of the electronic newsletter "VIG-NEWS" of the Federal Agency for Medicines and Health Products (FAMHP) is now available. The VIG-NEWS is a selection of recent news concerning pharmacovigilance from different sources.

A new regulatory framework aimed at strengthening and streamlining the system of pharmacovigilance in the EU will apply from July 2012. To facilitate the implementation of new activities for pharmacovigilance, the European Medicines Agency has established, in collaboration with the competent authorities of Member States, guidelines on good pharmacovigilance practices that are subject to public consultation since 22nd February.

The European Medicines Agency approves the WHO dose recommendations for anti-tuberculosis medicines used in children: ethambutol (MYAMBUTOL), isoniazid (NICOTIBINE), pyrazinamide (TEBRAZID) and rifampicin (RIFADINE). The FAMHP will take steps to ensure that the summary of product characteristics and the patient leaflet of these medicines are adapted according to these recommendations.

The European Medicines Agency informs physicians and patients that interactions were found between boceprevir (VICTRELIS used in the treatment of hepatitis C) and certain protease inhibitors of the AIDS virus, namely atazanavir (REYATAZ), darunavir (PREZISTA) boosted by ritonavir (Norvir) and lopinavir combined with ritonavir (KALETRA). Some associations are no longer recommended and monitoring is required during the concomitant administration of these medicines.