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. (Source: FDA MedWatch)
Source: FDA MedWatch - October 22, 2015 Category: American Health Source Type: news
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. (Source: FDA MedWatch)
Source: FDA MedWatch - October 22, 2015 Category: American Health Source Type: news
Downing Labs, LLC Sterile Compounded Products: Recall - Lack of Sterility Assurance
If there is a contamination in products intended to be sterile, patients are at risk of serious infections which may be life threatening. (Source: FDA MedWatch)
Source: FDA MedWatch - October 21, 2015 Category: American Health Source Type: news
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. (Source: FDA MedWatch)
Source: FDA MedWatch - October 15, 2015 Category: American Health Source Type: news
Acetaminophen Tablets by Medline Industries: Recall - Mislabeling with Incorrect Strength
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. (Source: FDA MedWatch)
Source: FDA MedWatch - October 15, 2015 Category: American Health Source Type: news
Bioprosthetic Aortic Valves: FDA Notification - Reduced Leaflet Motion
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. (Source: FDA MedWatch)
Source: FDA MedWatch - October 5, 2015 Category: American Health Source Type: news
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. (Source: FDA MedWatch)
Source: FDA MedWatch - October 3, 2015 Category: American Health Source Type: news
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. (Source: FDA MedWatch)
Source: FDA MedWatch - October 2, 2015 Category: American Health Source Type: news
Cranial Perforators With an Automatic Clutch Mechanism: Safety Communication - Failure to Disengage
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. (Source: FDA MedWatch)
Source: FDA MedWatch - September 28, 2015 Category: American Health Source Type: news
Sterile Compounded Products by US Compounding, Inc: Recall - Lack of Sterility Assurance
If the sterility of a compounded preparation intended to be sterile is compromised, patients may be at risk. (Source: FDA MedWatch)
Source: FDA MedWatch - September 24, 2015 Category: American Health Source Type: news
Avycaz (ceftazidime and avibactam): Drug Safety Communication - Dose Confusion and Medication Errors
FDA revised the labels to indicate that each vial contains Avycaz 2.5 gram, equivalent to ceftazidime 2 gram and avibactam 0.5 gram. (Source: FDA MedWatch)
Source: FDA MedWatch - September 22, 2015 Category: American Health Source Type: news
Tramadol: Drug Safety Communication - FDA Evaluating Risks of Using in Children Aged 17 and Younger
Ultra-rapid metabolizers are more likely to have higher-than-normal amounts of the active form of the opioid in their blood after taking tramadol, which can result in breathing difficulty that may lead to death. (Source: FDA MedWatch)
Source: FDA MedWatch - September 21, 2015 Category: American Health Source Type: news
Freedom Driver System by SynCardia: Class I Recall - Part May Fail Causing Device to Stop Working
If the device stops pumping, the patient will lose consciousness almost immediately, which can lead to serious injury or death. (Source: FDA MedWatch)
Source: FDA MedWatch - September 18, 2015 Category: American Health Source Type: news
Ayurvedic Dietary Supplements by Shree Baidyanath: Consumer Advice Notice - Products Contain High Levels of Lead and/or Mercury
Testing has found that these products contain high levels of lead and/or mercury, which can cause serious health problems. (Source: FDA MedWatch)
Source: FDA MedWatch - September 17, 2015 Category: American Health Source Type: news
Reprocessed Flexible Bronchoscopes: FDA Safety Communication - Risk of Infection
If scope reprocessing procedure is not followed meticulously, the flexible bronchoscope can remain contaminated, potentially resulting in infection transmission from one patient to the next. (Source: FDA MedWatch)
Source: FDA MedWatch - September 17, 2015 Category: American Health Source Type: news
