Tygacil (tigecycline): Label Change – Increased Mortality Risk
Healthcare professionals should consider alternatives to Tygacil in patients with severe infections.
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26. August 2010
Posted in: FDA Alerts and Warnings
Huber Needles: Recall – Risk of Coring
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.
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26. August 2010
Posted in: FDA Alerts and Warnings
Fingerstick Devices to Obtain Blood Specimens: Initial Communication – Risk of Transmitting Bloodborne Pathogens
Increase in reports of bloodborne infection transmission resulting from the shared use of fingerstick and point-of-care blood testing devices.
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25. August 2010
Posted in: FDA Alerts and Warnings
TimeOut Capsules: Undeclared Drug Ingredient
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.
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25. August 2010
Posted in: FDA Alerts and Warnings
MasXtreme Capsules (Natural Wellness) – product contains undeclared drug ingredient
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.
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25. August 2010
Posted in: FDA Alerts and Warnings
Octagam (Immune Globulin Intravenous (human)) 5% Liquid Preparation: Market Withdrawal – Risk of Thromboembolic Events
Customers asked to immediately quarantine the use of affected lots due to the potential for serious thromboembolic events.
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24. August 2010
Posted in: FDA Alerts and Warnings
Mr. Magic Male Enhancer: Undeclared Drug Ingredient
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.
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23. August 2010
Posted in: FDA Alerts and Warnings
INOMAX DS Drug-Delivery System: Class I Recall – Risk of Interruption of Drug Flow
Potential for failure of a pressure switch, which may have an impact on the administration of INOMAX for inhalation to patients.
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19. August 2010
Posted in: FDA Alerts and Warnings
Stalevo(carbidopa/levodopa and entacapone): Ongoing Safety Review: Possible increased cardiovascular risk
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
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16. August 2010
Posted in: FDA Alerts and Warnings
Midodrine hydrochloride: FDA Proposes Withdrawal of Low Blood Pressure Drug
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.
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1. September 2010
Posted in: FDA Alerts and Warnings