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Tag Archives: fda
Aliskiren containing Medications Drug Safety Comunication
Translation Aliskiren-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 … 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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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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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
Phenylephrine HCl Injection USP 1% 5 mL Vial Recall
TranslationUPDATED 02/23/2012] Phenylephrine HCl Injection, USP, 1% 5 mL Vial, (Lot# 0693) recalled. AUDIENCE: Pharmacy ISSUE: Recall initiated because some vials exhibit translucent visible particles consistent with glass delamination. Potential adverse events after intravenous administration include damage to blood vessels … Continue reading
Posted in Clinics, Emergency Rooms, FDA 2012, Hospitals, Pharmacy
Tagged (Lot# 0693), 1% 5 mL Vial, American Regent, Clinics, drug risks, Emergency Rooms, fda, FDA recall, Home Health Care Agencies, Hospitals, Infusion Centers, Pharmacy, Phenylephrine HCl Injection, Recall, USP)
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Vagifresh Ball Vagifresh Gel Female One Recall
TranslationVagifresh Ball, Vagifresh Gel, Female One: Recall – Undeclared Drug Ingredient, Bacterial Contamination AUDIENCE: Consumer, OB/GYN ISSUE: USA Far Ocean Group Inc. notified the public of a recall of Vagifresh Ball and Vagifresh Gel, sold as cosmetics. Vagifresh Gel was found … Continue reading
Posted in Consumer Products, FDA 2012, FDA Recall, FDA Warning, OBGYN
Tagged Bacterial Contamination, drug, drug risks, fda, FDA notice, FDA recall, FDA warning, Female One, OBGYN, Recall, Undeclared Drug Ingredient, USA Far Ocean Group Inc, Vagifresh Ball, Vagifresh Ball Vagifresh Gel Female One Recall, Vagifresh Gel
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December 2011 Safety Labeling Change
TranslationThe MedWatch December 2011 Safety Labeling Changes posting includes 40 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 2011, FDA Label Change, FDA Warning
Tagged Capoten, Danocrine, December 2011, December 2011 Safety Labeling Change, Desferal, Dilantin-125, drugs, Edarbi, Eloxatin, fda, Heparin, Isentress, Keppra, labeling change, Multaq tablets, Norvir, notice, Onglyza, Ovide, PegIntron, Plavix, Relenza, Remeron, safety, Tyzeka, warnings, Zegerid
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Bedford Laboratories Polymyxin B Vecuronium Bromide Recall
TranslationBedford Laboratories Polymyxin B For Injection USP And Vecuronium Bromide For Injection: Recall – Glass Particles AUDIENCE: Pharmacy, Risk Manager ISSUE: Bedford Laboratories issued guidance on the nationwide voluntary product recalls originally issued on August 2, 2011. The recalls were … Continue reading
Is Avandia Worth The Risk?
TranslationIs Avandia Worth The Risk? There has been several reported deaths from Avandia from heart attacks and strokes but meanwhile the FDA has refused to recall it. they have only recently updated their warnings about the increased risks to patients. … Continue reading
Posted in Avandia, Endocrinology, FDA 2011, FDA Warning
Tagged adverse, Avandia, Avandia(rosiglitazone), benefits, diabetes, drug, drug risks, effects, fda, FDA warning, lawsuits, Risks, safety label changes, side effects and risk of Avandia, type 2
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