PRAC News – October 2014
The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) concluded the safety reviews for valproate, testosterone and ponatinib at its October 2014 meeting.
PRAC recommends strengthening the restrictions on the use of valproate in women and girls
The Committee has recommended further restrictions on the use of valproate medicines due to the risk of malformations and developmental problems in children exposed to valproate in the womb. The PRAC also recommended that doctors who prescribe valproate provide women with full information to ensure that they understand the risks and to support their treatment decisions.
Valproate is used to treat epilepsy and bipolar disorder. Some valproate medicines have also been used in certain EU Member States to prevent migraine attacks.
More information on strengthening the restrictions on the use of valproate in women and girls is available on the HALMED and EMA webpages.
PRAC review does not confirm increase in heart problems with testosterone medicines
The PRAC review did not find consistent evidence that the use of testosterone in its authorised indication in men who do not produce enough testosterone (a condition known as hypogonadism) increases the risk of heart problems. The Committee considered that the benefits of testosterone continue to outweigh its risks but recommended that testosterone-containing medicines should only be used where lack of testosterone has been confirmed by signs and symptoms as well as laboratory tests.
More information on the PRAC’s safety review on cardiovascular risk in patients with hypogonadism treated with testosterone is available here.
PRAC recommends further measures to minimise risk of blood vessel blockage with Iclusig
The Committee completed its review of the cancer medicine Iclusig (ponatinib), which aimed to examine the risk of blood clots or blockage of the arteries or veins and to assess whether further measures were needed to minimise this risk. The PRAC considered that the benefits of Iclusig continue to outweigh its risks; however, it recommended that the product information for patients and healthcare professionals should be updated with strengthened warnings, particularly about the risk of blood clots and blockages of the arteries.
More information on further measures to minimise risk of blood vessel blockage with ponatinib is available here.
More information on the PRAC recommendations from the October 2014 meeting is available here.