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Monthly Archives: March 2012
Celexa citalopram hydrobromide FDA Drug Safety Communication
Translation Celexa (citalopram hydrobromide) – Drug Safety Communication: Revised Recommendations, Potential Risk of Abnormal Heart Rhythms AUDIENCE: Psychiatry, Cardiology ISSUE: FDA is clarifying dosing and warning recommendations for the antidepressant Celexa (citalopram hydrobromide; also available in generic form). In August 2011, … Continue reading
Posted in Cardiology, FDA 2012, FDA Safety Communication, Psychiatry
Tagged Cardiology, Celexa, Celexa citalopram hydrobromide FDA Drug Safety Communication, citalopram hydrobromide, drug risks, Drug Safety Communication, FDA Drug Safety Communication, FDA notice, FDA warning, Potential Risk of Abnormal Heart Rhythms, Psychiatry, Revised Recommendations, safety label changes
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Argatroban Injection 50 mg 50 mL 1 mg mL Recall
TranslationArgatroban Injection 50 mg/50 mL (1 mg/mL): Recall – Potential for Visible Particulates AUDIENCE: Pharmacy, Hematology ISSUE: Eagle Pharmaceuticals Inc., supplier to The Medicines Company, issued a voluntary recall of all four (4) lots of Argatroban Injection, 50 mg per 50 mL … Continue reading
Posted in FDA 2012, FDA Recall, Hematology, Pharmacy
Tagged 1 mg mL, 50 mg 50 mL, Argatroban Injection, Argatroban Injection 50 mg 50 mL 1 mg mL Recall, drug risks, Eagle Pharmaceuticals Inc., FDA recall, Recall, The Medicines Company
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Brilliant Blue G Recall
TranslationBrilliant Blue G: Recall of Unapproved Drug – Ongoing Investigation of Fungal Endophthalmitis Cases AUDIENCE: Ophthalmology, Risk Manager ISSUE: FDA has received reports of fungal endophthalmitis (eye infections) in patients who were given Brilliant Blue G (BBG) during eye surgeries. Clinicians … Continue reading
Posted in FDA 2012, FDA Recall, Ophthalmology, Risk Manager
Tagged Brilliant Blue G Recall, drug risks, eye infections, eye surgery, FDA recall, Franck’s Compounding Lab, fungal endophthalmitis, Fungal Endophthalmitis Cases, Ocala Florida, Ongoing Investigation, Ophthalmology, Recall, Unapproved Drug
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MedWatch February 2012 Safety Labeling Changes
TranslationThe MedWatch February 2012 Safety Labeling Changes posting includes 65 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT. The “Summary Page” provides a listing of drug names and … Continue reading
Posted in FDA 2012, FDA Label Change
Tagged Abilify (aripiprazole) Tablets, Amturnide (amlodipine/aliskiren/hydrochlorothiazide) tablets, and Injection, Angeliq (drospirenone and estradiol) tablets, Aptivus (tipranavir) Capsules and Oral Solution, Avalide (irbesartan/hydrochlorothiazide) tablets, Benicar (olmesartan medoxomil) Tablets, Beyaz (drospirenone/ethinyl estradiol/levomefolate calcium tablets and levomefolate calcium) tablets, Cardiogen-82 (Rubidium Rb 82 Generator), Crestor (rosuvastatin calcium) Tablets, Crixivan (indinavir sulfate) Capsules, Diovan HCT (valsartan/hydrochlorothiazide) Tablets, EES (erythromycin ethylsuccinate) Granules for oral suspension, Elestrin (estradiol gel), Ery-Ped liquid and PCE (erythromycin particles in tablets) 333 mg and 500 mg film coated tablets, Eryc (erythromycin delayed-release) capsules, Exforge HCT (amlodipine/valsartan/hydrochlorothiazide) tablets, Famvir (famciclovir) Tablets, February 2012, Hepsera (adefovir dipivoxil) tablets, Invirase (saquinavir mesylate) Capsules and Tablets, Kaletra (lopinavir/ritonavir) Tablets and Oral Solution, Lescol (fluvastatin sodium) Capsules, Lescol XL (fluvastatin sodium) Extended-Release Tablets, Letairis (ambrisentan) Tablets, Lexiva (fosamprenavir calcium) tablets and oral suspension, Lipitor (atorvastatin calcium) Tablets, Livalo (pitavastatin) tablets, Lotensin HCT (benazepril HCl and hydrochlorothiazide) Tablets, MedWatch, MedWatch February 2012 Safety Labeling Changes, Mevacor (lovastatin) Tablets, Natazia (estradiol valerate and estradiol valerate/dienogest) tablets, Norvir (ritonavir) oral solution and tablets, Oral Solution, Oral Suspension, Orally Disintegrating Tablets, Orencia (abatacept) for injection, Ozurdex (dexamethasone intravitreal) implant, Patanase (olopatadine hydrochloride) Nasal Spray, Phendimetrazine tartrate SR 105 mg capsules, Pravachol (pravastatin sodium) Tablets, Premarin (conjugated estrogens) Vaginal Cream, Prempro (conjugated estrogens/medroxyprogesterone acetate tablets) and Premphase (conjugated estrogens plus medroxyprogesterone acetate) tablets, Prezista (darunavir), Reyataz (atazanavir sulfate) Capsules, Rituxan (rituximab) Intravenous Injection, Safety Labeling Changes, Safyral (drospirenone/ethinyl estradiol/levomefolate calcium tablets and levomefolate calcium) tablets, Simcor (niacin ER/simvastatin) Tablets, Tekamlo (aliskiren/amlodipine) tablets, Tekturna (aliskiren) and Tekturna HCT (aliskiren/hydrochlorothiazide) Tablets, Valturna (aliskiren/valsartan) tablets, Vaseretic (enalapril maleate/hydrochlorothiazide) Tablets, Vasotec (enalapril maleate) Tablets, Viracept (nelfinavir mesylate) Oral Powder, Vytorin (ezetimibe/simvastatin) Tablets, Xalkori (crizotinib) Capsules, Yasmin (drospirenone/ethinyl estradiol) tablets, Zocor (simvastatin) Tablets, Zyvox (linezoid) Tablets and Oral Suspension
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Skin Lighteners and Anti aging Treatments
Translation Skin Creams, Soaps and Lotions Marketed as Skin Lighteners and Anti-aging Treatments: May Contain the Toxic Metal, Mercury Issue: FDA notified healthcare professionals and warned consumers not to use skin creams, beauty and antiseptic soaps, or lotions that might contain … Continue reading
Posted in Consumer Products, FDA 2012, Healthcare Professionals
Tagged Anti aging Treatments, Consumer Products, drug risks, FDA warning, Mercury, Skin Lighteners, Skin Lighteners and Anti aging Treatments, Toxic Metal, Unlabeled ingredients
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Acclarent Inspira AIR Balloon Dilation System Class 1 Recall
TranslationAcclarent Inspira AIR Balloon Dilation System: Class 1 Recall – Potential For Balloon To Not Deflate Or To Deflate To Slowly AUDIENCE: Emergency Medicine, Risk Managers ISSUE: Acclarent received four reports of incidents, one resulting in patient injury, in which … Continue reading
Gerber Good Start Gentle Powdered Infant Formula Recall
TranslationGerber Good Start Gentle Powdered Infant Formula: Recall – Off-Odor AUDIENCE: Consumers, Pediatrics ISSUE: Gerber notified the public that it recalled one lot of Gerber Good Start Gentle Powdered Infant Formula, 23.2 ounce plastic package, because the affected product might … Continue reading
Posted in Consumer Products, FDA 2012, FDA Recall, Pediatrics
Tagged Consumer Products, drug, FDA recall, Gentle Powdered, Gerber, Gerber Good Start Gentle Powdered Infant Formula Recall, Good Start, Infant Formula, Pediatrics, Recall
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Automated External Defibrillators AEDs Class I Recall
TranslationCardiac Science Powerheart, CardioVive, CardioLife; GE Responder and Responder Pro; and Nihon-Kohden Automated External Defibrillators (AEDs): Class I Recall – Defective Component Affected Models include: Powerheart 9300A, 9300E, 9300P, 9390A, and 9390E CardioVive 92532, 92533 CardioLife 9200G and 9231 GE … Continue reading
Posted in Cardiology, Emergency Rooms, FDA 2012, FDA Recall, Risk Manager
Tagged AEDs, Automated External Defibrillators, Cardiac Science Powerheart, CardioLife, Cardiology, CardioVive, Class 1 Recall, Class I Recall, Defective Component, Emergency Medicine, FDA recall, GE Responder, Nihon-Kohden, Recall, Responder Pro
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Statins and HIV or Hepatitis C Drugs Drug Safety Communication
TranslationStatins and HIV or Hepatitis C Drugs: Drug Safety Communication – Interaction Increases Risk of Muscle Injury AUDIENCE: Infectious Disease, Family Practice, Patients ISSUE: FDA notified healthcare professionals of updates to the prescribing information concerning interactions between protease inhibitors and certain statin drugs. … Continue reading
Posted in Family Practice, FDA 2012, FDA Safety Communication, Infectious Disease, Patients
Tagged drug interactions, drug risks, Drug Safety Communication, Family Practice, FDA notice, hiv, HIV or Hepatitis C Drugs, Infectious Disease, myopathy, Patients, protease inhibitors, Statins, Statins and HIV or Hepatitis C Drugs Drug Safety Communication
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