PRAC concludes assessment of gadolinium agents used in body scans and recommends regulatory actions, including suspension for some marketing authorisations Review finds evidence of gadolinium deposits in the brain after MRI body scans but no signs of harm
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EMA’s Pharmacovigilance and Risk Assessment Committee (PRAC) has recommended the suspension of the marketing authorisations for four linear gadolinium contrast agents because of evidence that small amounts of the gadolinium they contain are deposited in the brain.
PRAC investigates cancer medicine docetaxel
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.
New review of valproate use in pregnancy and women of childbearing age
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.
- EMA to review persistence of side effects known to occur with quinolone and fluoroquinolone antibiotics
- PRAC reviewing safety of pulmonary hypertension medicine Uptravi
- PRAC concludes that diabetes medicine canagliflozin may contribute to risk of toe amputation Risk may also apply to other medicines in the same class