MedWatch Safety Alerts

Title	Description	Pub Date
Tygacil (tigecycline): Label Change - Increased Mortality Risk	Healthcare professionals should consider alternatives to Tygacil in patients with severe infections.	1-Sep-2010
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.	26-Aug-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.	26-Aug-2010
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.	25-Aug-2010
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.	25-Aug-2010
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.	25-Aug-2010
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.	24-Aug-2010
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.	23-Aug-2010
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	19-Aug-2010
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.	16-Aug-2010