News FAMHP

The European Medicines Agency recommends contra-indicating the combination of aliskiren with an angiotensin-converting enzyme (ACE) inhibitor or with an angiotensin receptor blocker (sartan) to treat high blood pressure in patients with diabetes or kidney problems. The EMA also advises against this association in other patients.

The European Medicines Agency confirms the positive benefit / risk balance of orlistat-containing medicinal products. It recommends harmonizing the summary of product characteristics and patient leaflets of these medicinal products to ensure that information about adverse effects on the liver is the same for all them.

The findings of two new epidemiological studies confirm the results of the revaluation (completed in May 2011) of the YASMIN, YASMINELLE and YAZ contraceptives by the Pharmacovigilance Working Party of the European Medicines Agency: the risk of venous thromboembolism of these drospirenone-containing contraceptives is higher than that of second-generation contraceptives (containing levonorgestrel) but is similar to that of third generation contraceptives (containing desogestrel or gestodene). This risk is nevertheless very low. The benefit / risk balance of these medicinal products remains positive.

Following the recent news in the media about suppositories containing essential oils for babies and young children, the FAMHP woulod like to remind readers of its communication of 27th September 2011.

A new version of the document "detailed guidance on the collection, verification and presentation of adverse event / reaction reports arising from clinical trials on medicinal products for human use (" CT-3 ') " was published on June 11th 2011. A draft circular giving instructions arising from the transposition of these indications in Belgium is subject to comments of the relevant stakeholders.

In accordance with the decision of the Minister of Public Health, Laurette Onkelinx, the participants in the meeting on Thursday 2nd February 2012 focused on the practical implementation of the recommendations of the High Council of Health on PIP breast implants / M-implant.

The European Medicines Agency is re-evaluating aliskiren-containing medicines, antihypertensives that are authorised in Belgium under the name RASILEZ and RASILEZ HCT, following termination of a clinical study in which aliskiren was used in diabetic patients in combination with another antihypertensive medicine (an angiotensin converting enzyme inhibitor or a sartan). Whilst waiting for the results of this review doctors are advised not to prescribe aliskiren to diabetic patients already treated with the above-mentioned antihypertensive medicine.

The European Medicines Agency is re-evaluating the benefit / risk balance of Gilenya, a medicine indicated for the treatment of relapsing / remitting multiple sclerosis, following notification of cardiac events (? Problems?) that occurred after administration. Whilst waiting for the results of this review doctors are advised to intensify cardiovascular monitoring of the patients after administration of the first dose.

Thoughtless use of antibiotics poses a risk to public health as it promotes the appearance of resistant strains of bacteria. Therefore they make infections harder to treat. Measures have been taken in human medicine in order to use antibiotics appropriately. In order to reduce the consumption of antibiotics for veterinary use and promote their proper use, BelVet-SAC (Belgian Veterinary Surveillance of Antibiotic Consumption) and the centre of expertise AMCRA asbl (AntiMicrobial Consumption & Resistance in Animals) follow closely the amount of antibiotics consumed, monitor the emergence of bacterial resistance to them and make professionals in the veterinary sector aware of

The Federal Agency for Medicines and Health Products and the Federal Public Service Health, Food Chain Safety and Environment inform the public about a clinical trial with a vaccine consisting of a genetically modified organism from the firm Laboratorios HIPRA used to fight against swine pleuropneumonia.