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FDA MedWatch Safety Alerts
Administration of a solution containing glass particulate matter may result in inflammation and injury, or cause blockage of vasculature around the eye or emboli in the vasculature of eye nerves.
Posted: April 26, 2016, 9:30 pm
Fluconazole (Diflucan): Drug Safety Communication - FDA Evaluating Study Examining Use of Oral Fluconazole (Diflucan) in Pregnancy
Danish study shows possible increased risk of miscarriage. FDA advises cautious prescribing of oral fluconazole in pregnancy, until more is understood about this study.
Posted: April 26, 2016, 1:00 pm
Covidien Oridion Labeled Capnostream 20 and Capnostream 20p Patient Monitor Battery Packs by Medtronic: Recall - Risk of Thermal Damage
Thermal damage may cause fire, resulting in smoke inhalation and minor burns.
Posted: April 20, 2016, 8:30 pm
Administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death.
Posted: April 16, 2016, 3:42 pm
Drug Safety Labeling Changes includes 35 products with revisions to Prescribing Information. Posted 04/15/2015
Posted: April 15, 2016, 12:22 pm
Administration may result in localized swelling, redness, pain at the site of administration or veins, allergic reactions to the foreign particle, microembolic effects as well as possible fetal harm.
Posted: April 14, 2016, 3:00 pm
Inaccurate results may lead to improper patient treatment for HSV or GAS and may cause serious adverse health consequences, including death.
Posted: April 14, 2016, 11:30 am
Product poses significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.
Posted: April 12, 2016, 3:10 pm
Air leakage may lead to an air embolism, which could result in serious injury or death.
Posted: April 11, 2016, 6:40 pm
G4 Platinum and G5 Mobile Continuous Glucose Monitoring System Receivers by Dexcom: Class I Recall - Audible Alarm Failure
Relying on this product for notification of low/high blood sugar could result in serious adverse consequences, including death as the auditory alarm may not sound and users might not be notified of low/high blood sugar.
Posted: April 11, 2016, 4:00 am
Embolism of device fragments could lead to obstruction of blood flow or additional intervention to remove a device fragment surgically.
Posted: April 11, 2016, 4:00 am
Metformin-containing Drugs: Drug Safety Communication - Revised Warnings for Certain Patients With Reduced Kidney Function
FDA requiring changes to metformin labeling to provide specific recommendations on use in patients with mild to moderate kidney impairment.
Posted: April 8, 2016, 5:00 pm
Diabetes Medications Containing Saxagliptin and Alogliptin: Drug Safety Communication - Risk of Heart Failure
FDA adding new Warnings and Precautions to the labels of medicines that contain saxagliptin or alogliptin to inform of the potential increased risk of heart failure.
Posted: April 5, 2016, 6:10 pm
Continuum Labs LGD-4033 by Invisiblu International: Recall - Investigational Drug Not Approved for Use
Product found to contain LGD-4033 Ligandrol, an investigational drug not approved for use. The risks of using this product are unknown.
Posted: April 5, 2016, 4:30 pm
Urogynecologic Surgical Mesh Implants by Boston Scientific: Notification – Potential for Counterfeit Raw Material
FDA not recommending removal of this device, since the available data do not suggest any decreased benefit.
Posted: April 1, 2016, 6:45 pm
Interference between Computed Tomography (CT) and Electronic Medical Devices: Notification – Current Understanding of Potential Risk
Information about a rare and preventable type of interference between CT and electronic medical devices.
Posted: April 1, 2016, 4:15 pm
Administration of a non-sterile product, intended to be sterile, may result in serious and potentially life-threatening infections or death.
Posted: April 1, 2016, 4:00 am
5 Percent Dextrose Injection USP in PAB Container by B. Braun Medical: Recall - Leakage and/or Particulate Matter
Intravenous administration of a non-sterile product can result in serious infections that may be life-threatening.
Posted: March 29, 2016, 7:40 pm
OxySure Portable Emergency Oxygen System, Model 615 by OxySure Therapeutics, Inc: FDA Safety Communication - Do Not Use
Patients and other users of the affected device are at risk for serious adverse health consequences, such as burns and death.
Posted: March 29, 2016, 5:00 pm
Compounded Products by Reliable Drug Pharmacy: Recall - Potential for Mislabeling and Lack of Quality Assurance
Stop using recalled product immediately and arrange for the return of unused product.
Posted: March 28, 2016, 2:00 pm