Use associated with disabling and potentially permanent side effects of the tendons, muscles, joints, nerves, and central nervous system that can occur together in the same patient.
7/26/2016 4:01:00 PM
Administration of a drug product intended to be sterile that is compromised can result in health hazards including risk of serious infection or other complications.
7/22/2016 6:15:00 PM
Risk of surgical intervention to retrieve a separated segment, or other serious adverse health consequences such as internal organ injury, stroke, kidney failure, intestinal failure, and death.
7/22/2016 2:00:00 PM
Reports of hair loss, hair breakage, balding, itching, and rash.
7/19/2016 5:00:00 PM
The agency confirmed the product has been contaminated with Burkholderia Cepacia, a bacteria linked to an outbreak in five states.
7/16/2016 4:00:00 AM
Alere is working with the FDA to determine the most appropriate timing for product discontinuation and will provide guidance on transitioning patients to an alternate solution.
7/12/2016 7:30:00 PM
Sibutramine may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.
7/5/2016 4:30:00 PM
Batteries may lose power prematurely due to faulty cells.
6/29/2016 4:20:00 PM
Revised warnings in the drug labels to include information about acute kidney injury and added recommendations to minimize this risk.
6/14/2016 2:00:00 PM
Salmonella can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
6/8/2016 6:20:00 PM
Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.
6/7/2016 6:55:00 PM
Majority of reported problems occurred in individuals intentionally misusing and abusing high doses of loperamide in attempts to self-treat opioid withdrawal symptoms or to achieve a feeling of euphoria.
6/7/2016 1:00:00 PM
Risk of serious bleeding when using nonprescription, also known as over-the-counter or OTC, aspirin-containing antacid products.
6/6/2016 4:00:00 AM
Reports of severe redness, pain, skin discoloration, blistering, and cracked skin.
6/2/2016 5:00:00 PM
There may be a higher risk of patient infection associated with surgeries that introduced a prosthetic product/material [e.g., heart valve, graft, LVAD], or heart transplants when the 3T was used.
6/1/2016 5:55:00 PM
Manufacturing defect causes an increase in temperature within battery that may cause a fire.
5/27/2016 2:55:00 PM
Y-shaped connector and the yellow tube may disconnect from each other prior to or during use. This could lead to blood or fluid leakage, which may result in serious adverse health consequences, including death.
5/26/2016 5:10:00 PM
Skin and nail fungal infections in otherwise healthy persons are not life-threatening, and so the risks associated with oral ketoconazole outweigh the benefits. Posted 05/19/2016
5/19/2016 4:00:00 AM
Administration of a drug product intended to be sterile that is compromised may result in serious and potentially life-threatening infections or death.
5/18/2016 5:00:00 PM
FDA is currently investigating this new safety issue. Patients should not stop or change their diabetes medicines.
5/18/2016 4:56:00 PM
Sildenafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels.
5/13/2016 2:50:00 PM