Patient safety, news and press releases from EMA
- Mon, 11 Dec 2017 13:45:00 +0000: News and press releases: First guidance on monoclonal antibodies for use in animals - News and press releases
Guidance supports development of novel veterinary therapies
- Fri, 08 Dec 2017 16:00:00 +0000: News and press releases: Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 5–7 December 2017 - News and press releases
CVMP adopts revised guidance on use of pictograms and QR codes in packaging for veterinary medicinal products
- Mon, 04 Dec 2017 10:30:00 +0000: News and press releases: Call for patient organisation representatives to join the Committee for Orphan Medicines - News and press releases
Deadline for applications is 20 December 2017
- Fri, 01 Dec 2017 12:00:04 +0000: News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 27-30 November 2017 - News and press releases
PRAC starts two safety referrals and reaches conclusion on re-examination
- Fri, 01 Dec 2017 11:00:00 +0000: News and press releases: Regulatory guidance for pharmaceutical companies to prepare for UK’s withdrawal from EU - News and press releases
EMA and European Commission publish updated Q&As
MedWatch Safety Alert RSS Feed
- Tue, 05 Dec 2017 15:00:00 +0000: Pharmacist Choice Alcohol Prep Pads by Simple Diagnostics: Recall - Lack of Sterility Assurance and Other Quality Issues - MedWatch Safety Alert RSS Feed
The use of impacted alcohol prep pads could result in adverse events such as infections.
- Tue, 05 Dec 2017 12:30:00 +0000: Limbrel Capsules by Primus Pharmaceuticals: FDA Advisory - Linked to Potentially Life-Threatening Health Problems - MedWatch Safety Alert RSS Feed
UPDATED 12/05/2017. Anyone currently taking Limbrel may be at risk for developing symptoms associated with drug-induced liver injury and/or hypersensitivity pneumonitis.
- Fri, 01 Dec 2017 13:30:00 +0000: Albumin Human 25 Percent Solution (AlbuRx 25): Product Information Advisory - Fading Print On Label - MedWatch Safety Alert RSS Feed
Potential for fading print, with more effect on the expiration dating on the patient tear off portion of the vial label.
- Fri, 01 Dec 2017 13:10:00 +0000: Bull Capsules, Chao Jimengnan Tablets by Nutra Labs: Recall - Undeclared Drug Ingredients - MedWatch Safety Alert RSS Feed
Undeclared sildenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may cause a significant drop in blood pressure that may be life threatening.
- Tue, 28 Nov 2017 14:00:00 +0000: Biotin (Vitamin B7): Safety Communication - May Interfere with Lab Tests - MedWatch Safety Alert RSS Feed
Biotin in patient samples can cause falsely high or falsely low results, depending on the test. Incorrect test results may lead to inappropriate patient management or misdiagnosis.