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FDA MedWatch Safety Alerts
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.
Posted: July 22, 2016, 6:15 pm
Angiodynamics Soft Vu Omni Flush Angiographic Catheter by Stryker Sustainability Solutions (formerly Ascent Healthcare Solutions): Class I Recall - Tip Separation
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.
Posted: July 22, 2016, 2:00 pm
Reports of hair loss, hair breakage, balding, itching, and rash.
Posted: July 19, 2016, 5:00 pm
The agency confirmed the product has been contaminated with Burkholderia Cepacia, a bacteria linked to an outbreak in five states.
Posted: July 16, 2016, 4:00 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.
Posted: July 12, 2016, 7:30 pm
Dream Body 450mg, Dream Body Extreme Gold 800mg, Dream Body Advanced 400mg: Recall - Undeclared Drug Ingredient
Sibutramine may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.
Posted: July 5, 2016, 4:30 pm
HeartWare Ventricular Assist Device (HVAD) Batteries by HeartWare Inc.: Class I Recall - Premature Power Depletion
Batteries may lose power prematurely due to faulty cells.
Posted: June 29, 2016, 4:20 pm
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