MedWatch Safety Alerts

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FDA MedWatch Safety Alerts

Risk of stroke, kidney injury, or damage to the intestines or limbs.
Posted: February 11, 2016, 12:45 pm
If an immunocompromised patient or a child with an immature immune system ingests the contaminated product, there is a potential the patient will get an infection for which systemic antimicrobial therapy would be necessary.
Posted: February 11, 2016, 12:30 am
If the device operator does not intervene, the patient may not receive enough oxygen and could suffer serious adverse health consequences, including injury or death.
Posted: February 10, 2016, 6:00 pm
May contain sibutramine, phenolphthalein, and/or diclofenac.
Posted: January 29, 2016, 5:00 am
Exposure to lead can cause serious damage to the central nervous system, the kidneys, and the immune system.
Posted: January 28, 2016, 11:50 pm
Because the test strips are reporting falsely low blood glucose, there is a risk that the health care provider would not diagnose hyperglycemia (high blood sugar) in a timely manner and fail to treat elevated blood glucose levels.
Posted: January 28, 2016, 7:50 pm
Exposure to mercury can cause serious health problems, such as kidney and nervous system damage.
Posted: January 28, 2016, 5:00 am
The issue may prevent the ventilator from providing patient breathing support and could cause patient injury or death.
Posted: January 27, 2016, 9:30 pm
Solution contamination could lead to a worsened patient condition or death.
Posted: January 27, 2016, 12:30 pm
Manufacturing error may have caused damage to the insulation layer of one of the shock coils. This could result in the inability of the defibrillator to deliver electrical therapy to the patient.
Posted: January 26, 2016, 7:50 pm
Effects of morphine can include, but are not limited to, severe allergic reactions, respiratory depression, and death.
Posted: January 16, 2016, 5:00 am
Products include injectable medications, sterile solutions, eye drops, and eye ointments.
Posted: January 16, 2016, 5:00 am
Potential inaccuracies in the display by the navigation system could lead to inaccurate, ineffective medical procedures, and serious life-threatening injuries including death.
Posted: January 15, 2016, 6:20 pm
UPDATED 01/15/2016. FDA cleared the Olympus duodenoscope with modifications to device design & labeling intended to reduce the risk of bacterial infections.
Posted: January 15, 2016, 3:30 pm
An overdose of Guaifenesin DM may cause hyper excitability, rapid eye movements, changes in muscle reflexes, ataxia, dystonia, hallucinations, stupor, and coma.
Posted: January 13, 2016, 2:00 pm
May cause serious patient injury or death.
Posted: January 11, 2016, 5:00 am
Sildenafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels.
Posted: January 9, 2016, 7:45 pm
Salmonella can cause fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain.
Posted: January 8, 2016, 7:40 pm
If the ventilator shuts down, a patient may not receive necessary oxygen, which could cause patient injury or death.
Posted: January 6, 2016, 2:15 pm
Potential for delay in treatment that can result in life-threatening seizures, stroke, cerebral hemorrhage and maternal death, and attendant risks to the fetus, including fetal demise.
Posted: January 6, 2016, 2:00 pm