|
iPhone-friendly FDA News |
MedWatch Safety Alerts
Sep 08
Fragments of the catheter may become lodged in coronary arteries, resulting in serious injury or death.
Sep 01
Healthcare professionals should consider alternatives to Tygacil in patients with severe infections.
Aug 26
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.
Aug 26
Increase in reports of bloodborne infection transmission resulting from the shared use of fingerstick and point-of-care blood testing devices.
Aug 25
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.
Aug 25
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.
Aug 25
Customers asked to immediately quarantine the use of affected lots due to the potential for serious thromboembolic events.
Aug 24
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.
Aug 23
Potential for failure of a pressure switch, which may have an impact on the administration of INOMAX for inhalation to patients.
Aug 20
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
Aug 16
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.
Aug 13
Potentially life threatening episode of bleeding could occur during surgical procedures.
Aug 13
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.
Aug 12
Warnings and Precautions section of Prescribing Information and patient Medication Guide revised to include information about the risk of aseptic meningitis.
Aug 11
Products marketed as dietary supplement sexual enhancers for men contain undeclared sulfoaildenafil, which may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels.
Aug 09
Suspected counterfeit product is weaker, and breaks or bends before necessary force can be applied to stop blood flow. Excessive blood loss can endanger the victim’s life and ultimately lead to death.
Aug 09
Known long term risks associated with IVC filters include lower limb deep vein thrombosis, filter fracture, filter migration, filter embolization and IVC perforation.
Aug 09
Product contains undeclared
didesmethyl sibutramine, which may present a significant risk for patients with a history of coronary artery disease, congestive heart
failure, arrhythmias or stroke.
Aug 09
Product marketed as a dietary supplement sexual enhancer for men contains undeclared tadalafil, which may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels.
Aug 04
UPDATE 08/04/2010. Dear Healthcare Professional Letter issued. New Risk Management Plan. Reports of serious side effects in patients using Qualaquin "off-label" for night time leg cramps. Originally posted 07/08/2010
MedWatch Safety Alerts