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MedWatch Safety Alerts

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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
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
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
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
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
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
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
FDA not recommending removal of this device, since the available data do not suggest any decreased benefit.
Posted: April 1, 2016, 6:45 pm
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
Intravenous administration of a non-sterile product can result in serious infections that may be life-threatening.
Posted: March 29, 2016, 7:40 pm
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
Stop using recalled product immediately and arrange for the return of unused product.
Posted: March 28, 2016, 2:00 pm