Entries Tagged 'MedWatch' ↓
Tygacil (tigecycline): Label Change - Increased Mortality Risk
September 1st, 2010 — Food & Drugs, MedWatch
Healthcare professionals should consider alternatives to Tygacil in patients with severe infections.
Huber Needles: Recall - Risk of Coring
August 26th, 2010 — Food & Drugs, MedWatch
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
August 26th, 2010 — Food & Drugs, MedWatch
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
August 25th, 2010 — Food & Drugs, MedWatch
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
August 25th, 2010 — Food & Drugs, MedWatch
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
August 25th, 2010 — Food & Drugs, MedWatch
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
August 24th, 2010 — Food & Drugs, MedWatch
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
August 23rd, 2010 — Food & Drugs, MedWatch
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
August 19th, 2010 — Food & Drugs, MedWatch
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
August 16th, 2010 — Food & Drugs, MedWatch
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
August 13th, 2010 — Food & Drugs, MedWatch
Potentially life threatening episode of bleeding could occur during surgical procedures.
Prolatis’: Undeclared Drug Ingredient
August 13th, 2010 — Food & Drugs, MedWatch
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
August 12th, 2010 — Food & Drugs, MedWatch
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
August 11th, 2010 — Food & Drugs, MedWatch
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
August 9th, 2010 — Food & Drugs, MedWatch
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.