Medicinal Products

PRAC News – July 2016


At its July 2016 meeting, the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) concluded a safety referral on one medicine, and initiated three new safety referrals. It also discussed two ongoing reviews, extended the scope of an ongoing review, and tested its process and procedures for public hearings.

PRAC concludes review of Zydelig and issues updated recommendations for use

The PRAC 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 and follicular lymphoma. The PRAC however confirmed that there is a risk of serious infections with Zydelig, including Pneumocystis jirovecii pneumonia. It updated the recommendations on managing the risk of serious infections that were issued at the beginning of the review.

More information is available on the HALMED portal.

Review of modified-release paracetamol started

The PRAC initiated a review of the benefits and risks of modified- and prolonged-release paracetamol medicines, which are available in several EU Member States and are designed to release paracetamol over a prolonged period of time. There are no authorised medicines of the specified pharmaceutical form in the Republic of Croatia.

Modified- and prolonged-release paracetamol medicines are different from the usual immediate-release paracetamol medicines. Paracetamol-containing immediate release products have been authorised in all EU Member States, including the Republic of Croatia, and are not included in this review.

The standard procedures for assessing and managing overdose and poisoning with paracetamol are designed for the immediate-release products. The PRAC will evaluate available evidence to determine the risk from overdose with modified- and prolonged-release paracetamol, and whether any additional measures need to be taken.

More information is available on the HALMED portal.

Review of retinoid medicines initiated

The PRAC 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 is available on the HALMED portal.

Review of factor VIII medicines begins

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 the HALMED portal.

Extension of the scope of the review of canagliflozin to other medicines in the class

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 other medicines in this class (SGLT2 inhibitors).

More information on the July 2016 PRAC meeting can be found here.