Archive | August, 2010
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.
Continue reading...TimeOut Capsules: Undeclared Drug Ingredient
25. August 2010
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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.
Continue reading...MasXtreme Capsules (Natural Wellness) – product contains undeclared drug ingredient
25. August 2010
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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.
Continue reading...Mr. Magic Male Enhancer: Undeclared Drug Ingredient
24. August 2010
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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.
Continue reading...INOMAX DS Drug-Delivery System: Class I Recall – Risk of Interruption of Drug Flow
23. August 2010
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Potential for failure of a pressure switch, which may have an impact on the administration of INOMAX for inhalation to patients.
Continue reading...Stalevo(carbidopa/levodopa and entacapone): Ongoing Safety Review: Possible increased cardiovascular risk
19. August 2010
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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
Continue reading...Midodrine hydrochloride: FDA Proposes Withdrawal of Low Blood Pressure Drug
16. August 2010
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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.
Continue reading...6 French Engage Introducer Devices by St. Jude Medical: Recall – Potential for Separation of Shaft From Hub
13. August 2010
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Potentially life threatening episode of bleeding could occur during surgical procedures.
Continue reading...Prolatis’: Undeclared Drug Ingredient
13. August 2010
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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.
Continue reading...Lamictal (lamotrigine): Label Change – Risk of Aseptic Meningitis
12. August 2010
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Warnings and Precautions section of Prescribing Information and patient Medication Guide revised to include information about the risk of aseptic meningitis.
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26. August 2010
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