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Pharmacovigilance / «Citizens»

Companies to replace all current formulations containing lactose with lactose-free formulations.

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has recommended that injectable methylprednisolone medicines containing lactose, which potentially contain traces of cow’s milk proteins, must not be used in patients with a known or suspected allergy to the proteins in cow’s milk.

In addition, patients being treated for an allergic reaction with methylprednisolone should have their treatment stopped if their symptoms worsen or they develop new symptoms.

More information on the following link:

http://www.ema.europa.eu/

Registration opens for first public hearing

The European Medicines Agency (EMA) is inviting citizens to share their experience with valproate – a medicine that treats epilepsy, bipolar disorder and migraine – at its very first public hearing on 26 September 2017 at the Agency’s offices in London.

More information on the following link:

EMA seeks views of public during its safety review of valproate

Benefit-risk balance of certain linear gadolinium agents no longer favourable

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has confirmed its previous conclusion from March 2017 that there is convincing evidence of gadolinium deposition in brain tissues following use of gadolinium contrast agents.

No specific conditions linked to gadolinium deposition in the brain have been identified, but the clinical consequences are unknown.

More information on the following link:

Gadolinium-containing contrast agents

Review follows case of fulminant liver failure

The European Medicines Agency (EMA) has started a review of the medicine Zinbryta (daclizumab) used to treat adults with relapsing forms of multiple sclerosis (a disease in which inflammation damages the protective sheath around the nerve cells in the brain and spinal cord). The review follows the death from fulminant liver failure of a patient who was treated with Zinbryta in an ongoing observational study, as well as four cases of serious liver injury.

More information on the following link:

EMA reviews multiple sclerosis medicine Zinbryta

At its May meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) has completed its review of factor VIII medicines to evaluate the risk of developing inhibitors in patients with haemophilia A who have not previously been treated with these medicines.

Factor VIII is needed for blood to clot normally and is lacking in patients with haemophilia A. Factor VIII products replace the missing factor VIII and help control bleeding. However the body may develop inhibitors as a reaction to these medicines, particularly in patients starting treatment for the first time. This can block the effect of these medicines, so bleeding is no longer controlled.

The review was started following publication of a study which concluded that inhibitors develop more frequently in patients receiving recombinant factor VIII medicines than in those receiving plasma-derived factor VIII medicines. The PRAC concluded that there is no clear and consistent evidence of a difference in inhibitor development between the two classes of factor VIII medicines.

More information is available below:

PRAC concludes there is no clear and consistent evidence of a difference in inhibitor development between classes of factor VIII medicines

EMA’s Pharmacovigilance and Risk Assessment Committee (PRAC) has recommended the suspension of the marketing authorisations for four linear gadolinium contrast agents because of evidence that small amounts of the gadolinium they contain are deposited in the brain.

More detailed information on:

PRAC concludes assessment of gadolinium agents used in body scans and recommends regulatory actions, including suspension for some marketing authorisations

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) is warning that an increase in cases of lower limb amputation (mostly affecting the toes) has been observed in patients taking the type 2 diabetes medicine canagliflozin compared with those taking placebo (a dummy treatment) in two clinical trials, CANVAS and CANVAS-R. The studies, which are still ongoing, involved patients at high risk of heart problems.

More information on the following link:

PRAC concludes that diabetes medicine canagliflozin may contribute to risk of toe amputation

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