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FDA MedWatch Safety Alerts



Last Build Date: Sat, 07 Oct 2017 00:00:00 -0400

 



A1 Slim by Kiriko: Recall - Undeclared Drug Ingredients

Sat, 07 Oct 2017 00:00:00 -0400

Product tainted with sibutramine, phenolphthalein and N-Desmethyl sibutramine.



Intralipid 20 Percent IV Fat Emulsion by Baxter: Recall - One Shipment of Product Exposed to Subfreezing Temperatures

Fri, 06 Oct 2017 11:00:00 -0400

When subjected to freezing, emulsion droplets will increase in size, forming aggregates that can block pulmonary circulation/lead to serious adverse health consequences that can be life-threatening.



Intraocular Injections of a Compounded Triamcinolone, Moxifloxacin, and Vancomycin (TMV) Formulation: FDA Statement - Case of Hemorrhagic Occlusive Retinal Vasculitis

Tue, 03 Oct 2017 15:00:00 -0400

Prophylactic use of intraocular vancomycin, alone or in a compounded drug, during cataract surgery is generally not recommended because of the risk of HORV.



Infant Sleep Positioners: FDA Warning - Risk of Suffocation

Tue, 03 Oct 2017 10:00:00 -0400

FDA reminding parents and caregivers not to put babies in sleep positioners. These products, sometimes also called “nests” or “anti-roll” products, can cause suffocation that can lead to death.



Endovascular Graft Systems: Letter to Health Care Providers - Type III Endoleaks Associated with Use

Thu, 28 Sep 2017 11:00:00 -0400

Type III endoleak may require treatment with additional interventions such as re-lining, insertion of additional endograft components, or open surgical repair. Interventions to address endoleaks carry added risks for impacted patients.



Bridge Occlusion Balloon Catheter Model 590-001 by Spectranetics: Class I Recall - Risk of Blocked Guidewire Lumen Preventing Balloon Utilization

Tue, 26 Sep 2017 07:00:00 -0400

If device with blocked guidewire lumen were used, device would not be positioned correctly and hemorrhage would not be controlled, delaying life-saving treatment, which may result in serious adverse health consequences, including death.



TAH-t Companion 2 Driver System (C2) and Freedom Driver System by SynCardia Systems: Letter to Health Care Providers - Mortality and Neurological Adverse Event Results

Mon, 25 Sep 2017 13:30:00 -0400

UPDATED 09/25/2017. Most recent interim results from the ongoing SynCardia TAH-t post-approval study looking at mortality and neurological adverse events.



Vegetable Vigra by Natures Supplement: Recall - Undeclared Drug Ingredient

Thu, 21 Sep 2017 13:00:00 -0400

Men with diabetes, high blood pressure, high cholesterol, or heart disease, may be on medications that, taken with this product, could lower blood pressure to dangerous levels that could be life-threatening.



Ocaliva (obeticholic acid): Drug Safety Communication - Increased Risk of Serious Liver Injury

Thu, 21 Sep 2017 10:00:00 -0400

Reports of Ocaliva being incorrectly dosed in some patients with moderate to severe decreases in liver function. Some patients received a higher frequency of dosing than is recommended in the drug label.



Rhino 7, Papa Zen, Fifty Shades, and Grande X Dietary Supplements by Gadget Island: Recall - Undeclared Drug Ingredients

Wed, 20 Sep 2017 17:41:00 -0400

Use of products with undeclared active ingredients sildenafil, tadalafil and desmethyl carbodenafil may interact with nitrates and may cause a significant drop in blood pressure that may be life threatening.



Opioid Addiction Medications in Patients Taking Benzodiazepines or CNS Depressants: Drug Safety Communication - Careful Medication Management Can Reduce Risks

Wed, 20 Sep 2017 12:00:00 -0400

Health care professionals should develop a treatment plan when buprenorphine or methadone is used in combination with benzodiazepines or other CNS depressants.



Urogynecologic Surgical Mesh Implants by Boston Scientific: Notification – Potential for Counterfeit Raw Material

Tue, 19 Sep 2017 00:00:00 -0400

UPDATED 09/19/2017 Updating after extensive review of data and information.



OriGen VV28F Reinforced Dual Lumen ECMO Catheters: Recall - Potential for Separation of Extension Tube From Hub

Wed, 13 Sep 2017 14:00:00 -0400

Separation could result in required intervention to prevent permanent impairment/damage.



Diabetes Infusion Sets by Medtronic: Recall - Vent Membrane May be Susceptible to Being Blocked by Fluid

Tue, 12 Sep 2017 00:00:00 -0400

May lead to potential over-delivery of insulin shortly after an infusion set change, which may cause hypoglycemia. Posted 09/12/2017



Baby Organic Liquid Formula by Garden of Life: Recall - Directions For Use May Be Misinterpreted

Fri, 08 Sep 2017 14:00:00 -0400

If not administered precisely following the labeled instructions, the product may present difficulties in swallowing and potentially pose a choking hazard due to the thickness of the liquid.



Activase (alteplase) 100mg by Genentech: Recall - Lack of Sterility Assurance

Thu, 07 Sep 2017 00:00:00 -0400

The use of impacted Sterile Water for Injection could result in adverse events such as fever, chills, phlebitis, and granuloma or more severe adverse events such as sepsis or invasive systemic infections.



Intra-Aortic Balloon Pumps by Datascope/MAQUET: Class I Recall - False Blood Detection Alarm, Ingress of Fluid Into Pump

Wed, 06 Sep 2017 13:00:00 -0400

If therapy is stopped during use without a replacement IABP available, device failure may result in immediate and serious adverse health consequences, including death.



Kayexalate (sodium polystyrene sulfonate): Drug Safety Communication - FDA Recommends Separating Dosing

Wed, 06 Sep 2017 09:00:00 -0400

Too much potassium in the blood can cause problems with heart rhythm, which in rare cases can be fatal.



Hydromorphone HCl Injection, USP 2 mg/mL, and Levophed (Norepinephrine Bitartrate Injection, USP) 4 mg/4 mL (1 mg/mL) Vial by Hospira: Recall - Lack of Sterility Assurance

Tue, 05 Sep 2017 15:00:00 -0400

If impacted product is administered to a patient, adverse events ranging from fever, chills, and malaise, to severe adverse events such as septicemia, bacterial meningitides and wound infection could occur.



Alcohol Pads or Benzalkonium Chloride Antiseptic Towelettes by Foshan Flying Medical Products: FDA Alert - Lack of Sterility Assurance and Other Quality Issues

Fri, 01 Sep 2017 00:00:00 -0400

The use of these alcohol pads and antiseptic towelettes could cause infections.