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Patient safety, news and press releases from EMA

Tue, 11 Mar 2014 11:20:00 +0000: News and press releases: European Medicines Agency publishes first summary of a risk-management plan for a medicine – Patient safety, news and press releases: human and vet
The European Medicines Agency has published the first summary for the public of the risk-management plan (RMP) of a newly authorised medicine.
Mon, 10 Mar 2014 08:00:00 +0000: News and press releases: Joint EMA/FDA/MHLW-PMDA orphan medicinal product workshop takes place today – Patient safety, news and press releases: human and vet
A workshop on orphan product designation and grants is taking place today at the European Medicines Agency (EMA), jointly organised by the EMA, the US Food and Drug Administration (FDA) and for the first time the Japanese Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA).
Fri, 07 Mar 2014 12:00:01 +0000: News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 3-6 March 2014 – Patient safety, news and press releases: human and vet
The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) gave recommendations on three safety referrals at its March 2014 meeting.
Fri, 07 Mar 2014 12:00:00 +0000: News and press releases: PRAC recommends restricting use of domperidone – Patient safety, news and press releases: human and vet
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has completed a review of domperidone-containing medicines and has recommended changes to their use throughout the European Union (EU), including using these medicines only to relieve symptoms of nausea and vomiting, restricting the dose and adjusting doses carefully by weight where it is licensed in children.
Fri, 07 Mar 2014 12:00:00 +0000: News and press releases: PRAC recommends product information of zolpidem be updated with new advice to minimise the risk of next-morning impaired driving ability and mental alertness – Patient safety, news and press releases: human and vet
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has completed a review of zolpidem-containing medicines, used for the short-term treatment of insomnia (inability to sleep).

MedWatch Safety Alert RSS Feed

Wed, 12 Mar 2014 14:10:00 +0000: Greatbatch, Inc. Standard Offset Cup Impactors: Recall – Sterilization Recommendation in Instructions Do Not Meet Sterility Assurance Requirements – MedWatch Safety Alert RSS Feed
Lack of sterility assurance has the potential to result in surgical infection.
Fri, 07 Mar 2014 13:20:00 +0000: Effexor XR 150 Mg Extended-Release Capsules (Pfizer) and Venlafaxine HCl 150 Mg Extended-Release Capsules (Greenstone): Recall – Possible Presence of Tikosyn Capsules – MedWatch Safety Alert RSS Feed
The use of Tikosyn by an Effexor XR/Venlafaxine HCl patient could cause serious adverse health consequences that could be fatal.
Fri, 07 Mar 2014 01:20:00 +0000: Doribax (doripenem): Drug Safety Communication – Risk When Used to Treat Pneumonia on Ventilated Patients – MedWatch Safety Alert RSS Feed
Increased risk of death and lower clinical cure rates compared to use of imipenem and cilastatin.
Fri, 07 Mar 2014 01:20:00 +0000: DIANEAL PD-2 Peritoneal Dialysis Solution with 1.5 Percent Dextrose 6000mL: Recall – Contamination With Mold – MedWatch Safety Alert RSS Feed
Administration of a product contaminated with mold could result in life-threatening fungal peritoneal infection or sepsis.
Wed, 05 Mar 2014 15:10:00 +0000: HeartMate II LVAS Pocket System Controller by Thoratec Corporation: Medical Device Correction – Updated Labeling and Training Materials – MedWatch Safety Alert RSS Feed
Reports of four deaths and five incidents of loss of consciousness or other symptoms of hypoperfusion, occurring in patients who were converted to the Pocket Controller after being originally trained on an older model.