News FAMHP

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Make medicines safer by reporting side effects in children or during pregnancy or breast feeding. The FAMHP again participates in an international campaign to emphasize the importance of reporting side effects.

The campaign will run from the 19th to the 23rd of November and is part of an awareness week of 32 drug authorities from the EU, South America, the Middle East and Australia.

PRAC October 2018 – Recommendation to restrict the use of fluoroquinolone and quinolone antibiotics

During its meeting of October 2018, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has recommended restricting the use of fluoroquinolone and quinolone antibiotics.

PRAC July 2018 – Recommendation to restrict the use of prostate cancer medicine Xofigo

During its meeting of July 2018, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has recommended restricting the use of the cancer medicine Xofigo (radium-223 dichloride) to patients who have had two previous treatments for metastatic prostate cancer (prostate cancer that has spread to the bone) or who cannot receive other treatments.

Flash VIG-news: FENTANYL: reminder of appropriate use in order to minimize the risk of abuse, addiction or accidental overdose

The abuse or intentional misuse of fentanyl-based medicinal products may result in overdose and/or death. Accidental overdose through the transfer or ingestion of patches can also be fatal.

Flash VIG-news: PARACETAMOL - Reminder of the correct posology and precautions

The FAMHP reiterates the guidelines that were published in July 2014 about the correct posology and certain precautionary measures when using medicines based on paracetamol. The therapeutic indication of paracetamol is the symptomatic treatment of fever and pain.

PRAC April 2018 - Risk of dosing errors with methotrexate and unmet medical need for hydroxyethyl-starch (HES) solutions for infusion

During its meeting of April 2018, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has started a review of the risk of dosing errors with methotrexate medicines. The PRAC decided to further consider unmet medical need for hydroxyethyl-starch (HES) solutions for infusion and will discuss its recommendation at its May 2018 meeting.

Recommandation for immediate suspension and recall of multiple sclerosis medicine Zinbryta

EMA recommends immediate suspension and recall of multiple sclerosis medicine Zinbryta on basis of evidence indicating risk of serious inflammatory brain disorders.

Flash VIG-news : INSULINS in prefilled pens and cartridges for reusable pens: new recommendations

Following an alert from the United Kingdom's National Health Service (NHS), the European Medicines Agency Pharmacovigilance Risk Assessment Committee (PRAC) analysed reports of incidents linked to the extraction of insulin from prefilled pens and cartridges for reusable pens with the aid of a syringe. This practice can increase the risk of medication error and lead to dysglycaemia. However, until today, only the package leaflets of certain insulins mentioned the possibility of such extraction.

Flash VIG-news: DEPAKINE -medication error: confusion between Depakine 300 mg/5 ml syrup and Depakine 300 mg/ml drinkable solution

The FAMHP (pharmaco-, materio-, haemo-, bio-) Vigilance Division has recently been informed by pharmacists of medication errors due to confusion between Depakine 300 mg/5 ml syrup and Depakine 300 mg/ml drinkable solution. The FAMHP wishes to draw the attention of health professionals and patients to this risk of confusion.

Flash VIG-news: SACCHAROMYCES BOULARDII (in Belgium: ENTEROL®): risk of fungaemia and contraindication for seriously ill or immunosuppressed patients

Saccharomyces boulardii-based medicinal products are now contraindicated for seriously ill or immunosuppressed patients due to a risk of fungaemia.

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