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FDA MedWatch Safety Alerts
Serious adverse events reported, including pulmonary embolism, pulmonary infarction, myocardial embolism, myocardial infarction, embolic stroke, tissue necrosis, and death.
Posted: November 23, 2015, 2:00 pm
Clozapine: Drug Safety Communication - FDA Modifies Monitoring for Neutropenia; Approves New Shared REMS Program
UPDATED 11/19/2015: Clozapine REMS deadlines for prescribers and pharmacies extended.
Posted: November 19, 2015, 5:00 am
Iodine-containing Contrast Agents for Medical Imaging: Drug Safety Communication - Rare Cases of Underactive Thyroid in Infants
Labels of all iodinated contrast media (ICM) products will include information about these cases. No changes to current prescribing, administration, or monitoring practices are recommended.
Posted: November 17, 2015, 3:00 pm
If failure occurs, and the operator does not intervene, the patient may not receive enough oxygen and could suffer serious adverse health consequences, including injury or death.
Posted: November 14, 2015, 4:55 am
Endoscope Washer/Disinfectors by Custom Ultrasonics: Safety Communication - FDA Recommends Health Care Facilities Transition to Alternate Reprocessing Methods
Identified facility violations could result in an increased risk of infection transmission.
Posted: November 13, 2015, 7:10 pm
FDA review determines that long-term use of clopidogrel does not increase/decrease overall risk of death in patients with, or at risk for, heart disease, and does not suggest that clopidogrel increases risk of cancer/death from cancer.
Posted: November 6, 2015, 4:30 pm
Myocardial Protection System (MPS) Delivery Sets by Quest Medical: Recall - Intermittent Seal Failure During Use
Seal failure could result in patient blood loss.
Posted: October 29, 2015, 6:20 pm
If a patient experiencing a serious allergic reaction (i.e., anaphylaxis) does not receive the intended dose, there could be significant health consequences, including death.
Posted: October 29, 2015, 12:50 pm
Drug labels for Comtan and Stalevo will remain unchanged.
Posted: October 26, 2015, 2:40 pm
Hepatitis C Treatments Viekira Pak and Technivie: Drug Safety Communication - Risk of Serious Liver Injury
Cases of hepatic decompensation and liver failure in patients with underlying liver cirrhosis who were taking these medicines.
Posted: October 22, 2015, 7:25 pm
Kayexalate (sodium polystyrene sulfonate): Drug Safety Communication - FDA Requires Drug Interaction Studies
Prescribers and patients should consider separating Kayexalate dosing from other medications taken by mouth by at least 6 hours.
Posted: October 22, 2015, 4:58 pm
If there is a contamination in products intended to be sterile, patients are at risk of serious infections which may be life threatening.
Posted: October 21, 2015, 12:00 pm
Heater-Cooler Devices: FDA Safety Communication - Use of Devices Associated With Nontuberculous Mycobacteria Infections
Potential for contaminated water to transmit bacteria through the air (aerosolize) through the device’s exhaust vent into the environment and to the patient.
Posted: October 15, 2015, 5:00 pm
If the product is taken at the maximum labeled dose, or with other medications containing acetaminophen, it may lead to liver toxicity or liver failure.
Posted: October 15, 2015, 11:20 am
Beacon Tip Angiographic Catheters by Cook Medical: Class 1 Recall - Catheter Tip May Slip or Separate
UPDATED 10/13/2015. Expansion of the voluntary lot-specific recall. If this occurs, the tip could enter the patient’s bloodstream. This could cause serious injury to the patient and require additional medical intervention to retrieve the tip, or cause death.
Posted: October 13, 2015, 7:40 pm
FDA is working to design clinical studies to fully evaluate reduced valve leaflet motion. At this time, FDA believes that bioprosthetic aortic valves remain reasonably safe and effective when used according to their approved indications.
Posted: October 5, 2015, 6:40 pm
Drug Products Intended to be Sterile by Chen Shwezin Inc., dba Park Compounding Pharmacy: FDA Statement - Lack of Sterility Assurance
Administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death.
Posted: October 3, 2015, 4:00 am
PROFEMUR Neck Varus/Valgus CoCr 8 Degree, Part number PHAC 1254 by MicroPort Orthopedics: Class I Recall - Unexpected Rate of Fractures After Surgery
Acute fracture and emergency revision surgery is a serious adverse health consequence and could lead to neurovascular damage, hematoma, hemorrhage, or death.
Posted: October 2, 2015, 7:25 pm
Clutch mechanism may fail to disengage if proper use, patient considerations, and device selection are not followed in accordance with the manufacturer’s instructions for use.
Posted: September 28, 2015, 6:30 pm
If the sterility of a compounded preparation intended to be sterile is compromised, patients may be at risk.
Posted: September 24, 2015, 1:15 pm