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
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
CHMP confirms recommendations for use of Zydelig 2016-07-22
PRAC concludes review of Zydelig and issues updated recommendations for use 2016-07-08
CMDh endorses revocation of authorisations for fusafungine sprays used to treat airway infections 2016-04-01
EMA recommends new safety measures for Zydelig 2016-03-18
EMA confirms recommendations to minimise risk of brain infection PML with Tysabri 2016-02-26
EMA confirms recommendations to minimise ketoacidosis risk with SGLT2 inhibitors for diabetes 2016-02-26