Follow us:

MedWatch Safety Alerts

MedWatch Safety Alert RSS Feed

FDA MedWatch Safety Alerts

Revised warnings in the drug labels to include information about acute kidney injury and added recommendations to minimize this risk.
Posted: June 14, 2016, 2:00 pm
Salmonella can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
Posted: June 8, 2016, 6:20 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.
Posted: June 7, 2016, 6:55 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.
Posted: June 7, 2016, 1:00 pm
Risk of serious bleeding when using nonprescription, also known as over-the-counter or OTC, aspirin-containing antacid products.
Posted: June 6, 2016, 4:00 am
Reports of severe redness, pain, skin discoloration, blistering, and cracked skin.
Posted: June 2, 2016, 5:00 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.
Posted: June 1, 2016, 5:55 pm
Manufacturing defect causes an increase in temperature within battery that may cause a fire.
Posted: May 27, 2016, 2:55 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.
Posted: May 26, 2016, 5:10 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
Posted: May 19, 2016, 4:00 am
Administration of a drug product intended to be sterile that is compromised may result in serious and potentially life-threatening infections or death.
Posted: May 18, 2016, 5:00 pm
FDA is currently investigating this new safety issue. Patients should not stop or change their diabetes medicines.
Posted: May 18, 2016, 4:56 pm
Sildenafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels.
Posted: May 13, 2016, 2:50 pm
FDA urges health care professionals to purchase drug products only from legitimate suppliers.
Posted: May 13, 2016, 2:40 pm
Serious side effects associated with fluoroquinolones generally outweigh the benefits for patients with sinusitis, bronchitis, and uncomplicated urinary tract infections who have other treatment options.
Posted: May 12, 2016, 6:50 pm
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) can result in injury to organs including the liver, kidneys, lungs, heart, or pancreas, and can lead to death.
Posted: May 10, 2016, 4:01 pm
The presence of glass particulate matter could block drug administration, delaying therapy, and may also result in local inflammation, mechanical disruption of tissue, or cause an immune response.
Posted: May 9, 2016, 12:30 pm
The presence of air in dialysis fluid may lead to improper blood filtration, causing serious adverse health consequences, including death.
Posted: May 4, 2016, 2:30 pm
Degradation could lead to loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment.
Posted: May 4, 2016, 1:10 pm
Compulsive or uncontrollable urges to gamble, binge eat, shop, and have sex have been reported with the use of aripiprazole, and may result in harm to the patient and others if not recognized.
Posted: May 3, 2016, 4:30 pm