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FDA MedWatch Safety Alerts
Canagliflozin (Invokana, Invokamet) and Dapagliflozin (Farxiga, Xigduo XR): Drug Safety Communication - Strengthened Kidney Warnings
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
Loperamide (Imodium): Drug Safety Communication - Serious Heart Problems With High Doses From Abuse and Misuse
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
Over-the-Counter Antacid Products Containing Aspirin: FDA Drug Safety Communication - Serious Bleeding Risk
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
Zecuity (sumatriptan) Migraine Patch: Drug Safety Communication - FDA Evaluating Risk of Burns and Scars
Reports of severe redness, pain, skin discoloration, blistering, and cracked skin.
Posted: June 2, 2016, 5:00 pm
Stӧckert 3T Heater-Cooler System by Sorin Group Deustchland GmbH: Safety Communication - Reports of Mycobacterium Chimaera Infections
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
Capnostream 20 and Capnostream 20p Patient Monitor Battery Packs by Medtronic Respiratory and Monitoring Solutions: Class I Recall - Potential Fire Risk
Manufacturing defect causes an increase in temperature within battery that may cause a fire.
Posted: May 27, 2016, 2:55 pm
Hummi Micro-Draw Blood Transfer Device by Hummingbird Med Devices: Class I Recall - Potential for Parts to Disconnect
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
Nizoral (ketoconazole) Oral Tablets: Drug Safety Communication - Prescribing for Unapproved Uses including Skin and Nail Infections Continues; Linked to Patient Death
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
Canagliflozin (Invokana, Invokamet): Drug Safety Communication - Clinical Trial Results Find Increased Risk of Leg and Foot Amputations
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
BiCNU (carmustine for injection): FDA Alert - Counterfeit Product Discovered in Some Foreign Countries
FDA urges health care professionals to purchase drug products only from legitimate suppliers.
Posted: May 13, 2016, 2:40 pm
Fluoroquinolone Antibacterial Drugs: Drug Safety Communication - FDA Advises Restricting Use for Certain Uncomplicated Infections
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
PharMEDium Sterile Preparations Compounded With a Single Recalled Lot of Fresenius Kabi Sensorcaine-MPF (bupivacaine HCl): Recall - Presence of Glass Particulate Matter
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
Aripiprazole (Abilify, Abilify Maintena, Aristada): Drug Safety Communication - FDA Warns About New Impulse-control Problems
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