News Feeds
Patient safety, news and press releases from EMA
- Fri, 06 Dec 2013 12:00:01 +0000: News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 2-5 December 2013 – Patient safety, news and press releases: human and vet
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has started a further in-depth review of the benefits and risks of the leukaemia medicine Iclusig, particularly the risk of blood clots or blockages in the arteries or veins that is associated with the medicine. - Fri, 06 Dec 2013 11:59:00 +0000: News and press releases: PRAC considers benefits of Kogenate Bayer/Helixate NexGen outweigh risks in previously untreated patients – Patient safety, news and press releases: human and vet
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has reviewed the medicines Kogenate Bayer and Helixate NexGen and concluded that current evidence did not confirm an increased risk of developing antibodies (factor VIII inhibitors) against these medicines when compared with other factor VIII products in previously untreated patients with the bleeding disorder haemophilia A. - Fri, 06 Dec 2013 10:59:21 +0000: News and press releases: Further review of Iclusig started – Patient safety, news and press releases: human and vet
The European Medicines Agency has started an in-depth review of the benefits and risks of the leukaemia medicine Iclusig, particularly the risk of blood clots or blockages in the arteries or veins that is associated with the medicine. - Tue, 03 Dec 2013 09:40:00 +0000: News and press releases: European Medicines Agency applies greater fee-reduction rates for orphan medicines in 2014 – Patient safety, news and press releases: human and vet
The European Medicines Agency’s policy on fee reductions for orphan medicinal products has been revised. - Mon, 02 Dec 2013 11:25:00 +0000: News and press releases: Regulatory information – adjustment of linguistic review timetable for opinions adopted at December CHMP meeting – Patient safety, news and press releases: human and vet
The European Medicines Agency (EMA) has adjusted the post-opinion linguistic review timetable for opinions adopted at the 16-19 December 2013 meeting of the Committee for Medicinal Products for Human Use (CHMP), to take account of the Christmas break.
MedWatch Safety Alert RSS Feed
- Tue, 03 Dec 2013 15:22:00 +0000: Onfi (clobazam): Drug Safety Communication – Risk of Serious Skin Reactions – MedWatch Safety Alert RSS Feed
Cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) Reported. - Tue, 03 Dec 2013 05:00:00 +0000: HeartStart Automated External Defibrillators (AED) From Philips Healthcare: Safety Communication – Failure Of An Electrical Component That Could Cause AEDs To Fail To Deliver Appropriate Shock – MedWatch Safety Alert RSS Feed
When normal heart rhythms are not restored quickly, sudden cardiac arrest can cause death. - Sun, 01 Dec 2013 23:30:00 +0000: Hydravax Dietary Supplement by IQ Formulations: Recall – Possible Undeclared Drug Ingredient – MedWatch Safety Alert RSS Feed
Sample from one lot of Hydravax revealed the presence of a diuretic. Possible effects of using a diuretic include an electrolyte imbalance due to water loss. - Thu, 28 Nov 2013 22:20:00 +0000: FreeStyle and FreeStyle Lite Blood Glucose Test Strips by Abbott: Recall – Erroneously Low Blood Glucose Results – MedWatch Safety Alert RSS Feed
Falsely low blood glucose results can lead patients to try to raise their blood glucose when it isunnecessary, or to fail to treat elevated blood glucose due to a falsely low reading.
- Wed, 27 Nov 2013 19:00:00 +0000: Nitroglycerin in 5% Dextrose Injection by Baxter: Recall – Particulate Matter – MedWatch Safety Alert RSS Feed
Voluntary recall of one lot due to particulate matter found in one vial. If infused, particulate matter could lead to potential venous and/or arterial thromboembolism.