EMA Releases Pharmacovigilance Meeting Highlights

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The European Medicines Agency releases highlights from its Pharmacovigilance Risk Assessment Committee safety review meeting in October.

The European Medicines Agency (EMA) has released highlights from the Oct. 6-9, 2014 Pharmacovigilance Risk Assessment Committee (PRAC) meeting. In the meeting, PRAC discussed three safety reviews evaluating the use of valproate, the affect of testosterone medicines on the heart, and the risk of blood vessel blockage in the use of Iclusig.

PRAC concluded that further restrictions are needed on the use of valproate, a drug used to treat epilepsy and bipolar disorder, because of the risk of development problems in children exposed to the drug in the womb. The committee recommended that doctors give women the information needed to understand the risks involved with taking valproate.

In evaluating the risk of increased heart problems with the use of testosterone drugs, PRAC concluded that there was not enough evidence that use of testosterone in men who do not produce enough of the hormone (a condition known as hypogonadism) increased the risk of heart problems in those patients. PRAC, while stating that the benefits of testosterone outweigh its risks, recommended that testosterone-containing drugs should only be used when laboratory tests and signs and symptoms confirm a lack of testosterone.

PRAC reviewed the risk of blood clots or blockage of the arteries or veins associated with the cancer medicine Iclusig (ponatinib). PRAC also assessed whether further measures were needed to minimize such risk. The committee concluded that although the benefits of Iclusig continue to outweigh its risks, “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.”


Public consultation on the draft rules of procedures for public hearings, which describe the process for the preparation, conduct, and follow-up of public hearings, is open until Oct. 15, 2014. PRAC will consider public comments in its decision-making.

Source: EMA