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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

Effectiveness of measures for pregnancy prevention and for minimising possible risk of neuropsychiatric disorders to be evaluated

The European Medicines Agency (EMA) has started a review of retinoid medicines to evaluate measures currently in place for pregnancy prevention and for minimising the possible risk of neuropsychiatric disorders.

Retinoids (which include the active substances acitretin, adapalene, alitretinoin, bexarotene, isotretinoin, tazarotene and tretinoin) are taken by mouth or applied as creams or gels to treat several conditions mainly affecting the skin, including acne and psoriasis. Some retinoids are also used to treat certain forms of cancer.

More information on:

Retinoid-containing medicinal products

The PRAC started a review of medicines containing factor VIII to evaluate the risk of developing inhibitor proteins in patients starting treatment for haemophilia A. This follows the recent publication of a study whose authors suggested that inhibitors develop more frequently in patients receiving factor VIII medicines made by DNA recombinant technology than in those receiving factor VIII medicines derived from blood.

More information is available on:

Factor VIII

Extension of the scope of a safety review

The PRAC extended the scope of a review, which initially only covered canagliflozin, to include the other diabetes medicines in the same class, dapagliflozin and empagliflozin.

The Committee had initiated the review of canagliflozin in April 2016 after an increase in amputations mostly affecting toes was observed in an ongoing clinical trial called CANVAS. The scope of this referral was extended because the potential risk being evaluated for canagliflozin may be relevant for the other medicines in this class (SGLT2 inhibitors).

Practice run on public hearings

EMA conducted an internal practice exercise (dry run) in order to test the process and procedures for public hearings. Using a fictional scenario of a safety review, the PRAC experienced how such a hearing would take place. This has enabled EMA to ensure all practical arrangements needed for these hearings are in place and PRAC members to test this new form of interaction. Following this successful simulation, the PRAC is ready to incorporate public hearings as part of its core activities.

Public hearings are a new tool for EMA to engage European Union (EU) citizens in the regulation of medicines and to listen to their views and experiences. The pharmacovigilance legislation has given the PRAC the possibility to hold public hearings as part of certain safety reviews of medicines. Contributions made by the public during these hearings will be considered by the PRAC and inform the Committee’s decision-making.

Public hearings will be held on a case-by-case basis, where the Committee determines that collecting the views of the public would bring added value to its review. The first public hearing could take place as early as the fourth quarter of 2016, as soon as a relevant topic is identified.

More information is available on our 'public hearings' webpage as well as in the rules of procedure for these hearings.

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has completed its review of Zydelig (idelalisib), confirming that the medicine’s benefits outweigh its risks in the treatment of two types of blood cancers, chronic lymphocytic leukaemia (CLL) and follicular lymphoma. The PRAC however confirmed that there is a risk of serious infections with Zydelig, including Pneumocystis jirovecii pneumonia and has updated recommendations to manage this risk issued at the beginning of the review.

More information on:

PRAC concludes review of Zydelig and issues updated recommendations for use

EMA reviews diabetes medicine canagliflozin

Review follows data on toe amputations in ongoing study

The European Medicines Agency (EMA) has started a review of the diabetes medicine canagliflozin after an increase in amputations, mostly affecting toes, was observed in an ongoing clinical trial called CANVAS. Cases of lower limb amputation occurred in both the canagliflozin and placebo groups in the trial and the possibility that canagliflozin increases lower limb amputations is currently not confirmed. EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has requested more information from the company to assess whether canagliflozin causes an increase in lower limb amputations and whether any changes are needed in the way this medicine is used in the EU.

More information on this is included in the hyperlink below:

EMA reviews diabetes medicine canagliflozin

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