Aripiprazole (Abilify, Abilify Maintena, Aristada): Drug Safety Communication - FDA Warns About New Impulse-control Problems
Compulsive or uncontrollable urges to gamble, binge eat, shop, and have sex have been reported with the use of
aripiprazole, and may result in harm to the patient and others if not recognized. (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - May 3, 2016 Category: American Health Source Type: alerts
Brintellix (vortioxetine): Drug Safety Communication - Brand Name Change to Trintellix, to Avoid Confusion With Antiplatelet Drug Brilinta (ticagrelor)
During transition from the name Brintellix to Trintellix, prescribers can reduce the risk of name confusion by including the generic name of the medication they are ordering, in addition to the brand name and indication for use. (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - May 2, 2016 Category: American Health Source Type: alerts
Making It A Lifestyle, L.L.C. Supplements 3rd Degree, Black Gold X Advanced, and Black Label X: Recall - Undeclared Drug Ingredients
Undeclared sibutramine or sildenafil poses a threat to consumers. (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - May 2, 2016 Category: American Health Source Type: alerts
Sensorcaine-MPF (bupivacaine HCl) by Fresenius Kabi: Recall - Presence of Particulate Matter
Administration of a solution containing glass particulate matter by the epidural or retrobulbar (behind the eyeball) route may result in inflammation and injury, or cause blockage of vasculature around the eye or emboli in the vasculature of eye nerves. (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - April 26, 2016 Category: American Health Source Type: alerts
Fluconazole (Diflucan): Drug Safety Communication - FDA Evaluating Study Examining Use of Oral Fluconazole (Diflucan) in Pregnancy
Danish study shows possible increased risk of miscarriage. FDA advises cautious prescribing of oral fluconazole in pregnancy, until more is understood about this study. (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - April 26, 2016 Category: American Health Source Type: alerts
Covidien Oridion Labeled Capnostream 20 and Capnostream 20p Patient Monitor Battery Packs by Medtronic: Recall - Risk of Thermal Damage
Thermal damage may cause fire, resulting in smoke inhalation and minor burns. (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - April 20, 2016 Category: American Health Source Type: alerts
Sterile Drug Products from Pharmakon Pharmaceuticals: Recall - 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 Safety Alert)
Source: FDA MedWatch Safety Alert - April 16, 2016 Category: American Health Source Type: alerts
Sterile Drug Products from Pharmakon Pharmaceuticals, Inc: CDER Statement - FDA alerts health care professionals not to use due to a lack of sterility assurance and other quality issues
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 Safety Alert)
Source: FDA MedWatch Safety Alert - April 16, 2016 Category: American Health Source Type: alerts
March 2016
Drug Safety Labeling Changes includes 35 products with revisions to Prescribing Information. Posted 04/15/2015 (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - April 15, 2016 Category: American Health Source Type: alerts
50 Percent Magnesium Sulfate Injection, USP by Hospira: Recall - Presence Of Particulate Matter
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. (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - April 14, 2016 Category: American Health Source Type: alerts
Focus Diagnostics Laboratory Examination Kits: Class I Recall - Inaccurate Test Results
Inaccurate results may lead to improper patient treatment for HSV or GAS and may cause serious adverse health consequences, including death. (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - April 14, 2016 Category: American Health Source Type: alerts
Super Herbs Capsules: Recall - Undeclared Drug Ingredients
Product poses significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - April 12, 2016 Category: American Health Source Type: alerts
Guardian II Hemostasis Valves by Vascular Solutions, Inc: Recall - Risk of Air Leakage
Air leakage may lead to an air embolism, which could result in serious injury or death. (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - April 11, 2016 Category: American Health Source Type: alerts
G4 Platinum and G5 Mobile Continuous Glucose Monitoring System Receivers by Dexcom: Class I Recall - Audible Alarm Failure
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. (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - April 11, 2016 Category: American Health Source Type: alerts
Fetch 2 Aspiration Catheter by Boston Scientific: Recall - Shaft Breakage
Embolism of device fragments could lead to obstruction of blood flow or additional intervention to remove a device fragment surgically. (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - April 11, 2016 Category: American Health Source Type: alerts
