MedWatch Safety Alerts
Tygacil (tigecycline): Label Change - Increased Mortality Risk
Healthcare professionals should consider alternatives to Tygacil in patients with severe infections.
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.
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.
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.
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.
Octagam (Immune Globulin Intravenous (human)) 5#37; 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.
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.
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.
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
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.