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Pharmacovigilance / «Citizens»

Review triggered by cases of liver injury

The European Medicines Agency (EMA) has started a review of the medicine Esmya (ulipristal acetate) used to treat uterine fibroids (non-cancerous tumours of the womb). This follows four reports of serious liver injury, three of which ended in liver transplantation, in patients treated with the medicine. It is estimated that around 670,000 patients have been treated with Esmya to date. While the review is ongoing, patients should contact their doctor if they have any questions or concerns about their treatment.

More information:

Esmya. EMA starts review of Esmya for uterine fibroids

No clear and consistent evidence exists of a difference in risk between plasma-derived and recombinant factor VIII medicines

Following a re-examination procedure, EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has confirmed its previous conclusion of May 2017 that there is no clear and consistent evidence of a difference in the incidence of inhibitor development between the two classes of factor VIII medicines: those derived from plasma and those made by recombinant DNA technology.

Factor VIII is needed for blood to clot normally and is lacking in patients with haemophilia A. Factor VIII medicines replace the missing factor VIII and help control and prevent 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 medicines’ effect, so bleeding is no longer controlled.

Due to the different characteristics of individual products within the two classes, the PRAC reaffirmed that the risk of inhibitor development should be evaluated individually for each medicine, regardless of class. The risk for each product will continue to be assessed as more evidence becomes available.

To reflect the evidence currently available, the PRAC confirmed its recommendations that the prescribing information should be updated to include, as appropriate, inhibitor development as a very common side effect in previously untreated patients, and as an uncommon side effect in previously treated patients. The warning on inhibitor development should be amended to highlight that low levels of inhibitors pose less risk of severe bleeding than high levels.

The PRAC’s final recommendation will now be sent to EMA’s Committee for Medicinal Products for Human Use (CHMP) for the adoption of EMA’s opinion. Further details and information for patients and healthcare professionals will be published at that time.

More detailed information:

Factor VIII

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

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