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October 21, 2017 at 12:00 AM
Administration of a drug product, intended to be sterile, that may contain microbial contamination has the potential to result in serious adverse events which may include life-threatening infections. Posted 10/21/2017
October 19, 2017 at 3:30 PM
UPDATED 10/19/2017. St. Jude Medical notified physicians of the Battery Performance Alert (BPA), a new tool that detects and notifies physicians of abnormal battery performance that may lead to premature battery depletion.
October 07, 2017 at 12:00 AM
Product tainted with sibutramine, phenolphthalein and N-Desmethyl sibutramine.
October 06, 2017 at 11:00 AM
When subjected to freezing, emulsion droplets will increase in size, forming aggregates that can block pulmonary circulation/lead to serious adverse health consequences that can be life-threatening.
October 03, 2017 at 3:00 PM
Prophylactic use of intraocular vancomycin, alone or in a compounded drug, during cataract surgery is generally not recommended because of the risk of HORV.
October 03, 2017 at 10:00 AM
FDA reminding parents and caregivers not to put babies in sleep positioners. These products, sometimes also called “nests” or “anti-roll” products, can cause suffocation that can lead to death.
September 28, 2017 at 11:00 AM
Type III endoleak may require treatment with additional interventions such as re-lining, insertion of additional endograft components, or open surgical repair. Interventions to address endoleaks carry added risks for impacted patients.
September 26, 2017 at 7:00 AM
If device with blocked guidewire lumen were used, device would not be positioned correctly and hemorrhage would not be controlled, delaying life-saving treatment, which may result in serious adverse health consequences, including death.
September 25, 2017 at 6:30 PM
If device with blocked guidewire lumen were used, device would not be positioned correctly and hemorrhage would not be controlled, delaying life-saving treatment, which may result in serious adverse health consequences, including death.
September 25, 2017 at 1:30 PM
UPDATED 09/25/2017. Most recent interim results from the ongoing SynCardia TAH-t post-approval study looking at mortality and neurological adverse events.
September 21, 2017 at 1:00 PM
Men with diabetes, high blood pressure, high cholesterol, or heart disease, may be on medications that, taken with this product, could lower blood pressure to dangerous levels that could be life-threatening.
September 21, 2017 at 10:00 AM
Reports of Ocaliva being incorrectly dosed in some patients with moderate to severe decreases in liver function. Some patients received a higher frequency of dosing than is recommended in the drug label.
September 20, 2017 at 5:41 PM
Use of products with undeclared active ingredients sildenafil, tadalafil and desmethyl carbodenafil may interact with nitrates and may cause a significant drop in blood pressure that may be life threatening.
September 20, 2017 at 12:00 PM
Health care professionals should develop a treatment plan when buprenorphine or methadone is used in combination with benzodiazepines or other CNS depressants.
September 19, 2017 at 12:00 AM
UPDATED 09/19/2017 Updating after extensive review of data and information.
September 13, 2017 at 2:00 PM
Separation could result in required intervention to prevent permanent impairment/damage.
September 12, 2017 at 12:00 AM
May lead to potential over-delivery of insulin shortly after an infusion set change, which may cause hypoglycemia. Posted 09/12/2017
September 08, 2017 at 2:00 PM
If not administered precisely following the labeled instructions, the product may present difficulties in swallowing and potentially pose a choking hazard due to the thickness of the liquid.
September 07, 2017 at 12:00 AM
The use of impacted Sterile Water for Injection could result in adverse events such as fever, chills, phlebitis, and granuloma or more severe adverse events such as sepsis or invasive systemic infections.
September 06, 2017 at 1:00 PM
If therapy is stopped during use without a replacement IABP available, device failure may result in immediate and serious adverse health consequences, including death.
September 06, 2017 at 9:00 AM
Too much potassium in the blood can cause problems with heart rhythm, which in rare cases can be fatal.
September 05, 2017 at 3:00 PM
If impacted product is administered to a patient, adverse events ranging from fever, chills, and malaise, to severe adverse events such as septicemia, bacterial meningitides and wound infection could occur.
September 01, 2017 at 12:00 AM
An extreme and unexpected reduction in dose than expected could lead to a delay in treatment, disruption of clinical care of the patient, and worsening of patient's conditions.
September 01, 2017 at 12:00 AM
The use of these alcohol pads and antiseptic towelettes could cause infections.
August 31, 2017 at 11:00 AM
Risks associated with the use of Keytruda in combination with dexamethasone and an immunomodulatory agent (lenalidomide or pomalidomide) for the treatment of patients with multiple myeloma.