Patient safety, news and press releases from EMA
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- Sat, 01 Aug 2015 02:00:00 +0000: Hydrochlorothiazide Tablets by Unichem Pharmaceuticals (USA), Inc: Recall – Potential Presence of Foreign Tablets Contamination – MedWatch Safety Alert RSS Feed
Missing a dose of Hydrochlorothiazide could result in uncontrolled blood pressure or swelling caused by excess fluid (edema).
- Fri, 31 Jul 2015 18:55:00 +0000: Symbiq Infusion System by Hospira: FDA Safety Communication – Cybersecurity Vulnerabilities – MedWatch Safety Alert RSS Feed
The device could be accessed remotely through a hospital’s network. This could allow an unauthorized user to control the device and change the dosage the pump delivers, which could lead to over- or under-infusion of critical patient therapies.
- Fri, 31 Jul 2015 16:45:00 +0000: 0.9 Percent Sodium Chloride Injection, USP (AUTO-C) by Baxter International: Recall – Potential For Leaking Containers, Particulate Matter and Missing Port – MedWatch Safety Alert RSS Feed
Leaking containers, particulate matter and missing port protectors could result in contamination of the solution. If not detected, this could lead to a bloodstream infection or other serious adverse health consequences.
- Thu, 30 Jul 2015 15:25:00 +0000: Brintellix (vortioxetine) and Brilinta (ticagrelor): Drug Safety Communication – Name Confusion – MedWatch Safety Alert RSS Feed
FDA warns about prescribing and dispensing errors resulting from brand name confusion with antidepressant Brintellix (vortioxetine) and antiplatelet Brilinta (ticagrelor).
- Mon, 27 Jul 2015 19:25:00 +0000: Adrucil (fluorouracil injection, USP) 5 g/100 mL (50 mg/mL) by Teva Parenteral Medicines: Recall – Particulate Matter – MedWatch Safety Alert RSS Feed
Administration of an intravenous product with particulate matter has the potential to result in inflammation, allergic reactions, or blockage of blood vessels, leading to tissue death, which may be life-threatening if vital organs are affected.