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Monthly Archives: April 2012
Victrelis drug label revised Drug Safety Communication
Translation Victrelis (boceprevir) and Ritonavir-Boosted Human Immunodeficiency Virus (HIV) Protease Inhibitor Drugs: Drug Safety Communication – Drug Interactions [UPDATED 04/26/2012] FDA notified healthcare professionals that the Victrelis drug label has been revised to state that co-administration of Victrelis (boceprevir), a … Continue reading
Posted in FDA 2012, FDA Label Change, FDA Safety Communication, Infectious Disease, Pharmacy
Tagged drug interactions, drug risks, Drug Safety Communication, FDA notice, FDA warning, Infectious Disease, Pharmacy, Ritonavir-Boosted Human Immunodeficiency Virus (HIV), safety label changes, Victrelis (boceprevir)
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Elecsys Troponin I and STAT Immunoassays Recall
TranslationRoche Diagnostics Operations Elecsys Troponin I and Elecsys Troponin I STAT Immunoassays: Recall – Doctors may receive a falsely low result AUDIENCE: Cardiology, Laboratory ISSUE: With certain types of plasma samples, doctors may receive a falsely low result (up to … Continue reading
Posted in Cardiology, FDA 2012, FDA Recall, Laboratory
Tagged Cardiology, drug risks, Elecsys Troponin I, Elecsys Troponin I and STAT Immunoassays Recall, Laboratory, Recall, Roche Diagnostics Operations, STAT Immunoassays
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FDA Warning Brilliant Blue G
TranslationCertain Compounded Drugs from Franck’s: FDA Issues Second Warning to Physicians Brilliant Blue G (BBG) Triamcinolone AUDIENCE: Eye Care, Family Practice, Pharmacy ISSUE: FDA has received additional reports of fungal endophthalmitis (eye infections) in patients who were given Brilliant Blue … Continue reading
Posted in Eye Care, Family Practice, FDA 2012, FDA Warning, Pharmacy
Tagged Brilliant Blue G, Eye Care, eye infections, Family Practice, FDA warning, fungal endophthalmitis, Pharmacy, Triamcinolone
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Aliskiren containing Medications Drug Safety Comunication
TranslationAliskiren-containing Medications: Drug Safety Comunication – New Warning and Contraindication including: Amturnide (aliskiren hemifumarate, amlodipine besylate, and hydrochlorothiazide) Tekturna (aliskiren hemifumarate) Tekturna HCT (aliskiren hemifumarate and hydrochlorothiazide) Tekamlo (aliskiren hemifumarate and amlodipine besylate) Valturna (aliskiren hemifumarate and valsartan). Valturna will … Continue reading
Posted in Endocrinology, FDA 2012, FDA Safety Communication, Internal Medicine, Pharmacy
Tagged Aliskiren containing Medications, aliskiren hemifumarate, aliskiren hemifumarate and amlodipine besylate, aliskiren hemifumarate and hydrochlorothiazide, aliskiren hemifumarate and valsartan, amlodipine besylate, Amturnide, and hydrochlorothiazide, Drug Safety Communication, Endocrinology, fda, Internal Medicine, Pharmacy, Tekamlo, Tekturna, Tekturna HCT, Valturna
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Generic Ultrasound Transmission Gel Safety Communication
TranslationOther‐Sonic Generic Ultrasound Transmission Gel: Safety Communication – Risk of Bacterial Contamination AUDIENCE: Risk Manager, OB/GYN, Radiology, Infectious Disease ISSUE: FDA notified health care professionals and facilities to STOP using Other‐Sonic Generic Ultrasound Transmission Gel manufactured June though December 2011, … Continue reading
Posted in FDA 2012, FDA Warning, Infectious Disease, OBGYN, Radiology, Risk Manager
Tagged drug risks, FDA notice, Generic Ultrasound Transmission Gel, Infectious Disease, OBGYN, Other‐Sonic, Radiology, Risk Manager, Safety Communication
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Morphine Sulfate Injection USP Carpuject by Hospira Recall
TranslationMorphine Sulfate Injection USP, 4 mg/mL (C-II), 1 mL fill in 2.5 mL Carpuject by Hospira, Inc: Recall – May Contain More Than Intended Fill Volume AUDIENCE: Risk Manager, Pain Management ISSUE: Customer report of two Carpujects syringes containing more … Continue reading
FDA March 2012 Safety Labeling Changes
TranslationThe MedWatch March 2012 Safety Labeling Changes posting includes 39 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 safety … Continue reading
Posted in FDA 2012, FDA Label Change, FDA Safety Communication
Tagged Atacand HCT candesartan cilextetil/hydrochlorothiazide, Benicar olmesartan medoxomil, Benlysta belimumab, Celexa citalopram hydrobromide, drug risks, Drug Safety Communication, Enablex darifenacin, fda, FDA March 2012 Safety Labeling Changes, FDA notice, Incivek telaprevir, Janumet sitagliptin and metformin fixed-dose combination, Januvia sitagliptin, Kombiglyze XR saxagliptin/metformin hydrochloride extended-release, Lidocaine in 5% Dextrose Injection Magnevist brand of gadopentetate dimeglumine, March 2012, Revlimid lenalidomide, Reyataz atazanavir sulfate, safety label changes, Safety Labeling Changes, Sporanox itraconazole, Treximet sumatriptan and naproxen sodium, Twynsta telmisartan/amlodipine, Votrient pazopanib, Zestoretic lisinopril/hydrochlorothiazide, Zestril lisinopril, Zmax azithromycin extended release, Zometa zoledronic acid
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Birth Control Pills Health Risks
TranslationBirth Control Pills Containing Drospirenone: Label Change-Products may be associated with a higher risk for blood clots AUDIENCE: OBGYN, Family Practice, Patient ISSUE: FDA has completed its review of recent observational (epidemiologic) studies regarding the risk of blood clots … Continue reading
Posted in Family Practice, FDA 2012, FDA Label Change, OBGYN, Patients
Tagged Birth Control Pills, Birth Control Pills Health Risks, Drospirenone, drug risks, Family Practice, FDA notice, Health Risks, higher risk for blood clots, OBGYN, safety label changes
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Thoratec Corporation HeartMate II Left Ventricular Assist System LVAS Class 1 Recall
TranslationThoratec Corporation, HeartMate II Left Ventricular Assist System (LVAS): Class 1 Recall- Outflow Graft May Kink or Deform Audience: Cardiology , Risk Manager, Transplant Issue: FDA is notifying health care professionals of a Class 1 Recall due to detachment of the … Continue reading
Posted in Cardiology, FDA 2012, FDA Recall, Risk Manager
Tagged Cardiology, Class 1 Recall, Class I Recall, drug risks, FDA recall, HeartMate II LVAS, Left Ventricular Assist System LVAS, Recall, Risk Manager, Thoratec Corporation HeartMate II, Thoratec Corporation HeartMate II Left Ventricular Assist System LVAS Class 1 Recall, Transplant, Ventricular Assist System
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Altuzan bevacizumab Counterfeit Product
TranslationAltuzan (bevacizumab): Counterfeit Product – Contains no Active Ingredient ISSUE: FDA lab tests have confirmed that a counterfeit version of Roche’s Altuzan 400mg/16ml (bevacizumab),an injectable cancer medication, found in the U.S. contains no active ingredient. Even if the identified … Continue reading
Posted in Family Practice, FDA 2012, FDA Recall, FDA Warning, Healthcare Professionals, Oncology, Patients
Tagged Altuzan, Altuzan bevacizumab Counterfeit Product, bevacizumab, Cancer Drugs, Counterfeit Product, drug risks, Family Practice, FDA recall, FDA warning, Oncology, or Ban Dune Marketing Inc, Recall, Richards Pharma, Richards Services, Roche’s Altuzan 400mg/16ml, Unapproved Drug, Warwick Healthcare Solutions
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