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FDA MedWatch Safety Alerts
Nizoral (ketoconazole) Oral Tablets: Drug Safety Communication - Prescribing for Unapproved Uses including Skin and Nail Infections Continues; Linked to Patient Death
Skin and nail fungal infections in otherwise healthy persons are not life-threatening, and so the risks associated with oral ketoconazole outweigh the benefits. Posted 05/19/2016
Posted: May 19, 2016, 4:00 am
Administration of a drug product intended to be sterile that is compromised may result in serious and potentially life-threatening infections or death.
Posted: May 18, 2016, 5:00 pm
Canagliflozin (Invokana, Invokamet): Drug Safety Communication - Clinical Trial Results Find Increased Risk of Leg and Foot Amputations
FDA is currently investigating this new safety issue. Patients should not stop or change their diabetes medicines.
Posted: May 18, 2016, 4:56 pm
Sildenafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels.
Posted: May 13, 2016, 2:50 pm
BiCNU (carmustine for injection): FDA Alert - Counterfeit Product Discovered in Some Foreign Countries
FDA urges health care professionals to purchase drug products only from legitimate suppliers.
Posted: May 13, 2016, 2:40 pm
Fluoroquinolone Antibacterial Drugs: Drug Safety Communication - FDA Advises Restricting Use for Certain Uncomplicated Infections
Serious side effects associated with fluoroquinolones generally outweigh the benefits for patients with sinusitis, bronchitis, and uncomplicated urinary tract infections who have other treatment options.
Posted: May 12, 2016, 6:50 pm
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) can result in injury to organs including the liver, kidneys, lungs, heart, or pancreas, and can lead to death.
Posted: May 10, 2016, 4:01 pm
PharMEDium Sterile Preparations Compounded With a Single Recalled Lot of Fresenius Kabi Sensorcaine-MPF (bupivacaine HCl): Recall - Presence of Glass Particulate Matter
The presence of glass particulate matter could block drug administration, delaying therapy, and may also result in local inflammation, mechanical disruption of tissue, or cause an immune response.
Posted: May 9, 2016, 12:30 pm
The presence of air in dialysis fluid may lead to improper blood filtration, causing serious adverse health consequences, including death.
Posted: May 4, 2016, 2:30 pm
Degradation could lead to loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment.
Posted: May 4, 2016, 1:10 pm
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.
Posted: May 3, 2016, 4:30 pm
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.
Posted: May 2, 2016, 7:10 pm
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.
Posted: May 2, 2016, 2:25 pm
Administration of a solution containing glass particulate matter may result in inflammation and injury, or cause blockage of vasculature around the eye or emboli in the vasculature of eye nerves.
Posted: April 26, 2016, 9:30 pm
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.
Posted: April 26, 2016, 1:00 pm
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.
Posted: April 20, 2016, 8:30 pm
Administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death.
Posted: April 16, 2016, 3:42 pm
Drug Safety Labeling Changes includes 35 products with revisions to Prescribing Information. Posted 04/15/2016
Posted: April 15, 2016, 12:22 pm
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.
Posted: April 14, 2016, 3:00 pm
Inaccurate results may lead to improper patient treatment for HSV or GAS and may cause serious adverse health consequences, including death.
Posted: April 14, 2016, 11:30 am