Food and Drug Adminstration (FDA): MedWatch

Tygacil (tigecycline): Label Change - Increased Mortality Risk

09/01/2010 09:00 AM
Healthcare professionals should consider alternatives to Tygacil in patients with severe infections.

Huber Needles: Recall - Risk of Coring

08/26/2010 02:40 PM
Risk of infection, damage or death of tissue, swelling, or other serious adverse health consequences occurring as a result of the core travelling through blood vessels into the patient’s lungs.

Fingerstick Devices to Obtain Blood Specimens: Initial Communication - Risk of Transmitting Bloodborne Pathogens

08/26/2010 01:30 PM
Increase in reports of bloodborne infection transmission resulting from the shared use of fingerstick and point-of-care blood testing devices.

TimeOut Capsules: Undeclared Drug Ingredient

08/25/2010 02:25 PM
Product marketed as dietary supplement contains undeclared hydroxythiohomosildenafil, a chemical similar to sildenafil, which may interact with nitrates found in some prescription drugs and lower blood pressure to dangerous levels.

MasXtreme Capsules (Natural Wellness) - product contains undeclared drug ingredient

08/25/2010 11:38 AM
UPDATED 08/25/2010. Product marketed as dietary supplement contains undeclared Aminotadalafil, which may interact with nitrates found in some prescription drugs and lower blood pressure to dangerous levels.

Octagam (Immune Globulin Intravenous (human)) 5% Liquid Preparation: Market Withdrawal - Risk of Thromboembolic Events

08/25/2010 10:00 AM
Customers asked to immediately quarantine the use of affected lots due to the potential for serious thromboembolic events.

Mr. Magic Male Enhancer: Undeclared Drug Ingredient

08/24/2010 10:15 AM
Product marketed as dietary supplement contains undeclared hydroxythiohomosildenafil and sulfoaildenafil, which may interact with nitrates found in some prescription drugs and lower blood pressure to dangerous levels.

INOMAX DS Drug-Delivery System: Class I Recall - Risk of Interruption of Drug Flow

08/23/2010 07:50 PM
Potential for failure of a pressure switch, which may have an impact on the administration of INOMAX for inhalation to patients.

Stalevo(carbidopa/levodopa and entacapone): Ongoing Safety Review: Possible increased cardiovascular risk

08/19/2010 11:00 PM
FDA evaluating clinical trial data that suggest patients taking drug may be at an increased risk for cardiovascular events compared to those taking carbidopa/levodopa

Midodrine hydrochloride: FDA Proposes Withdrawal of Low Blood Pressure Drug

08/16/2010 02:45 PM
Companies failed to provide evidence of clinical benefit of midodrine hydrochloride because required post-approval studies that verify the clinical benefit of the drug have not been done.

6 French Engage Introducer Devices by St. Jude Medical: Recall - Potential for Separation of Shaft From Hub

08/13/2010 01:35 PM
Potentially life threatening episode of bleeding could occur during surgical procedures.

Prolatis’: Undeclared Drug Ingredient

08/13/2010 08:55 AM
Product marketed as dietary supplement contains undeclared sulfoaildenafil, which may interact with nitrates found in some prescription drugs and lower blood pressure to dangerous levels.

Lamictal (lamotrigine): Label Change - Risk of Aseptic Meningitis

08/12/2010 02:14 PM
Warnings and Precautions section of Prescribing Information and patient Medication Guide revised to include information about the risk of aseptic meningitis.

Novacare LLC Products: Recall - Undeclared Drug Ingredient

08/11/2010 01:00 PM
Products marketed as dietary supplement sexual enhancers for men contain undeclared sulfoaildenafil, which may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels.

Combat Application Tourniquets (C-A-T): Suspected Counterfeit Product

08/09/2010 12:30 PM
Suspected counterfeit product is weaker, and breaks or bends before necessary force can be applied to stop blood flow. Excessive blood loss can endanger the victim’s life and ultimately lead to death.

Inferior Vena Cava (IVC) Filters: Initial Communication: Risk of Adverse Events with Long Term Use

08/09/2010 10:20 AM
Known long term risks associated with IVC filters include lower limb deep vein thrombosis, filter fracture, filter migration, filter embolization and IVC perforation.

Solo Slim, Solo Slim Extra Strength: Recall - Undeclared Drug Ingredient

08/09/2010 08:25 AM
Product contains undeclared didesmethyl sibutramine, which may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.

Revivexxx Extra Strength: Recall - Undeclared Drug Ingredient

08/09/2010 08:05 AM
Product marketed as a dietary supplement sexual enhancer for men contains undeclared tadalafil, which may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels.

Qualaquin (quinine sulfate): New Risk Evaluation and Mitigation Strategy - Risk of serious hematological reactions

08/04/2010 11:38 AM
UPDATE 08/04/2010. Dear Healthcare Professional Letter issued. New Risk Management Plan. Reports of serious side effects in patients using Qualaquin "off-label" for night time leg cramps. Originally posted 07/08/2010

Cook brand Ciaglia Blue Rhino/Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Sets and Trays

08/04/2010 09:35 AM
UPDATE 08/04/2010. Recall classified as Class I - balloon inflation assembly may not hold air. Originally posted 07/22/2010

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