Идентификация

EMA’s safety committee (PRAC) is recommending new measures to avoid dosing errors that have led to some patients incorrectly taking methotrexate-containing medicines daily instead of weekly.

The new measures include restricting who can prescribe these medicines, making warnings on the packaging more prominent and providing educational materials for patients and healthcare professionals. In addition, to help patients follow the once-weekly dosing, methotrexate tablets for weekly use will be provided in blister packs and not in bottles (or tubes).

Methotrexate is used for treating both inflammatory diseases and cancers. When used for inflammatory diseases, such as arthritis and psoriasis, it is taken once a week but for some types of cancer, a much higher dosage is needed and the medicine is taken more frequently. Mistakes in prescribing or dispensing methotrexate as well as misunderstandings of the dosing schedule have led to patients taking the medicine daily instead of weekly for inflammatory diseases, with serious consequences, including fatalities

Мore information:

https://www.ema.europa.eu/en/medicines/human/referrals/methotrexate-containing-medicinal-products

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

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

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

EMA to consider if risks of these medicines require further restrictions of use

The European Medicines Agency (EMA) has started a review looking at the use of valproate-containing medicines in the treatment of women and girls who are pregnant or of childbearing age. These medicines are approved nationally in the EU to treat epilepsy, bipolar disorder and in some countries, migraine, and have been previously reviewed by the Agency.

More information on the following link:

New review of valproate use in pregnancy and women of childbearing age

EMA to review persistence of side effects known to occur with quinolone and fluoroquinolone antibiotics

Review to focus on long-lasting effects mainly affecting musculoskeletal and nervous systems

The European Medicines Agency (EMA) is reviewing systemic and inhaled quinolone and fluoroquinolone antibiotics to evaluate the persistence of serious side effects mainly affecting muscles, joints and the nervous system. These side effects are of particular importance when the medicines are used for less severe infections.

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EMA to review persistence of side effects known to occur with quinolone and fluoroquinolone antibiotics

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) is reviewing the safety of Uptravi (selexipag), following the deaths of 5 patients taking the medicine in France. Based on a preliminary review of available data, EMA advises that Uptravi may continue to be used, but use must be in line with the current prescribing information.

The PRAC will further explore all available data. Once the review is completed, final conclusions will be published.

More information:

EMA reviewing safety of Uptravi for pulmonary arterial hypertension (updated)

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

EMA to review certain injectable medicines to treat allergy

Risks of some methylprednisolone products in patients allergic to cows' milk proteins to be investigated

The European Medicines Agency (EMA) has started a review of certain medicines given by injection to treat severe, rapidly developing (acute) allergic reactions. The medicines involved contain the corticosteroid methylprednisolone as active ingredient. They also include as an additional ingredient lactose (milk sugar), which potentially contains traces of cows' milk proteins that could affect treatment of acute reactions in the small number of highly sensitive patients allergic to these proteins.

More information:

Medicinal products containing lactose of bovine origin for IV/IM use in acute allergic reactions