Идентификация

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

Overdose complex and difficult to manage with modified-release products

Following a review, the European Medicines Agency’s experts in medicines safety have recommended that modified- or prolonged-release paracetamol products (designed to release paracetamol slowly over a longer period than the usual immediate-release products) should be suspended from marketing. This is in view of the risks to patients from the complex way these medicines release paracetamol into the body after an overdose.

Experience has shown that in overdose (particularly at high doses), because of the way the paracetamol in modified-release products is released in the body, the usual treatment procedures developed for immediate-release products are not appropriate. If doctors are not aware modified-release paracetamol has been taken, which affects decisions such as when and for how long to give an antidote, overdose might result in severe liver damage or death. In modified-release products that also contain the painkiller tramadol this could be complicated further because of the additional effects of overdose with tramadol.

In many cases, it may not be known whether an overdose of paracetamol involves immediate-release or modified-release products, making it difficult to decide what type of management is needed. The Committee could not identify means to minimise the risk to patients, or a feasible and standardised way to adapt the management of paracetamol overdose across the EU to allow for treatment of cases that involve modified-release preparations. It concluded on balance that the risk following overdose with these medicines outweighs the advantage of having a longer-acting preparation. The Committee therefore recommended that marketing of modified-release paracetamol medicines should be suspended. Immediate-release paracetamol products, which are not affected by this review, will continue to be available as before.

More information on this is included in the hyperlink below:

Paracetamol-modified release

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

PRAC concludes there is no clear and consistent evidence of a difference in inhibitor development between 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.

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

The PRAC is investigating the cancer medicine docetaxel following cases of neutropenic enterocolitis in patients in France. Most of the patients were being treated for operable breast cancer.

A preliminary assessment by the PRAC indicates that the frequency of this known side effect has not increased in the last two years. A thorough evaluation of available data is being carried out and final conclusions will be published once the review has been completed.

More detailed information on:

Pharmacovigilance Risk Assessment Committee (PRAC): 6-9 March 2017