Patient safety

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This page lists EMA communications on important changes to the authorisation of medicines to improve patient safety, which have been recommended by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP), the Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) or the Pharmacovigilance Risk Assessment Committee (PRAC). 

The page lists patient safety communications from the last two years. For a full list of all changes made to a centrally authorised medicine, see its European public assessment report. For information on referrals, see referrals.

Patient safety Last updated
Update on review of valsartan medicines due to detection of NDMA 2018-08-10
Esmya: new measures to minimise risk of rare but serious liver injury 2018-08-08
Update on review of recalled valsartan medicines 2018-08-02
EMA restricts use of prostate cancer medicine Xofigo 2018-07-27
Update on review of valsartan medicines following detection of impurity in active substance 2018-07-17
EMA reviewing medicines containing valsartan from Zhejiang Huahai following detection of an impurity 2018-07-05
Hydroxyethyl starch solutions: CMDh introduces new measures to protect patients 2018-06-29
Esmya: new measures to minimise risk of rare but serious liver injury 2018-06-01
EMA review of Zinbryta confirms medicine’s risks outweigh its benefits 2018-05-18
New study suggests risk of birth defects in babies born to women on HIV medicine dolutegravir 2018-05-18
Eye injuries in people and dogs when using Osurnia ear gel for dogs 2018-04-20
EMA reviewing risk of dosing errors with methotrexate 2018-04-13
New measures to avoid valproate exposure in pregnancy endorsed 2018-03-23
Updated measures for pregnancy prevention during retinoid use 2018-03-23
Withdrawal of pain medicine flupirtine endorsed 2018-03-23
Colour change for insulin injection Fiasp to avoid mix ups with Tresiba 2018-03-23
Prostate cancer medicine Xofigo must not be used with Zytiga and prednisone/prednisolone 2018-03-09
EMA recommends immediate suspension and recall of multiple sclerosis medicine Zinbryta 2018-03-07
EMA urgently reviewing multiple sclerosis medicine Zinbryta following cases of inflammatory brain disorders 2018-03-02
PRAC recommends new measures to avoid valproate exposure in pregnancy 2018-02-09
Women taking Esmya for uterine fibroids to have regular liver tests while EMA review is ongoing 2018-02-09
Hydroxyethyl-starch solutions for infusion to be suspended – CMDh endorses PRAC recommendation 2018-01-26
Defect with Buccolam oral syringes 2018-01-15
Modified-release paracetamol-containing products to be suspended from EU market 2017-12-15
EMA concludes review of Zinbryta and confirms further restrictions to reduce risk of liver damage 2017-11-10
EMA starts new review of hydroxyethyl-starch containing medicines 2017-10-27
Review of flupirtine-containing medicines started 2017-10-27
PRAC recommends further restrictions for multiple sclerosis medicine Zinbryta due to risk of serious liver damage 2017-10-27
EMA recommends suspension of medicines due to unreliable studies from Micro Therapeutic Research Labs 2017-03-24
SGLT2 inhibitors: information on potential risk of toe amputation to be included in prescribing information 2017-02-24
Dienogest/ethinylestradiol can be used for acne after certain other treatments have failed 2017-01-27
Direct-acting antivirals for hepatitis C: EMA confirms recommendation to screen for hepatitis B 2016-12-16
Use of metformin to treat diabetes now expanded to patients with moderately reduced kidney function 2016-10-14
EMA recommends measures to ensure safe use of Keppra oral solution 2016-10-14