EMA and the national competent authorities are reminding patients with confirmed or suspected coronavirus disease (COVID-19) to report suspected side effects that they experience with any of the medicines they are taking.
Read more: Reporting suspected side effects of medicines in patients with COVID-19
Review follows case of fulminant liver failure
The European Medicines Agency (EMA) has started a review of the medicine Zinbryta (daclizumab) used to treat adults with relapsing forms of multiple sclerosis (a disease in which inflammation damages the protective sheath around the nerve cells in the brain and spinal cord). The review follows the death from fulminant liver failure of a patient who was treated with Zinbryta in an ongoing observational study, as well as four cases of serious liver injury.
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Concerning confirmed cases of WNV for 2018 in neighbouring countries (Romania, Greece) , Bulgarian Drug Agency as the Competent authorities with regard to the activities of blood establishments and blood banks for collection, testing, processing, storage and distribution of human blood and blood components, consider the set up of the following measures as indispensable:
1.Strengthen surveillance of donor selection through extensive clinical examination and interviews, and especially for the residents and visitors of the affected areas and areas with high risk of mosquito bites - rivers, lakes, reservoirs.
2.Increasing awareness of the staff in blood establishments and blood banks and especially in the regions along Danube river and West border region along Struma river.
3.The donors will be required to inform Blood Establishmets and blood banks, if within a period of 15 days after donation he/she found the appearance of a febrile episodes or skin rush.
4.Temporary deferral of potential donors doubtful for disease for 28 days after leaving the areas with high risk of mosquito bites - rivers, lakes, reservoirs or flu-like symptoms pass away. ( for the period between June and October ).
The measures will be in force between June and October 2019.
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.
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Pharmacovigilance Risk Assessment Committee (PRAC): 6-9 March 2017
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.
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New review of valproate use in pregnancy and women of childbearing age
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.
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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.
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The European Medicines Agency (EMA) has started a review of the risk of gadolinium deposition in brain tissue following the use of gadolinium contrast agents in patients having magnetic resonance imaging (MRI) scans.
Gadolinium contrast agents are diagnostic products that may be given to patients before or during MRI scans to help doctors obtain better images of organs and tissues. After administration, gadolinium agents are mostly eliminated via the kidneys but studies indicate that deposits can build up in some body tissues, including in the liver, kidney, muscle, skin and bone.
Read more: EMA reviewing gadolinium contrast agents used in MRI scans
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.
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