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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

 
Information for medical specialists

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

 
Information for medical specialists

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

 
Information for medical specialists

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

 
Information for medical specialists

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).

 
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