1. September 2010

Posted in: FDA Alerts and Warnings

Tygacil (tigecycline): Label Change – Increased Mortality Risk

Healthcare professionals should consider alternatives to Tygacil in patients with severe infections.
Continue reading...

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.
Continue reading...

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.
Continue reading...

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.
Continue reading...

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.
Continue reading...

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.
Continue reading...

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.
Continue reading...

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.
Continue reading...

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
Continue reading...

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.
Continue reading...
PHVsPjwvdWw+