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Category Archives: FDA Label Change
April 2013 Safety Labeling Changes
The MedWatch April 2013 Safety Labeling Changes posting includes 48 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 2013, FDA Label Change, FDA Safety Communication
Tagged April 2013, April 2013 Safety Labeling Changes, drug risks, Drug Safety Communication, fda, FDA notice, Safety Communication, safety label changes, Safety Labeling Changes
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Medical Bed Mattresses FDA Safety Communication
Medical Bed Mattresses: FDA Safety Communication – Damaged or Worn Covers Pose Risk of Contamination and Infection AUDIENCE: Biomedical Engineering, Infectious Disease, Nursing, Risk Managers ISSUE: From January 2011 to January 2013, the FDA received 458 reports associated with medical … Continue reading
Posted in Biomedical Engineering, FDA 2013, FDA Label Change, FDA Safety Communication, Infectious Disease, Nursing, Risk Manager
Tagged Biomedical Engineering, Drug Safety Communication, FDA notice, FDA Safety Communication, Infectious Disease, Medical Bed Mattresses, Medical Bed Mattresses FDA Safety Communication, Nursing, Risk Manager, Risk Managers, Safety Communication
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MedWatch March 2013 Safety Labeling Changes
The MedWatch March 2013 Safety Labeling Changes posting includes 53 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
MedWatch December 2012 Safety Labeling Changes
The MedWatch December 2012 Safety Labeling Changes posting includes 42 products with safety labeling changes to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT. The “Summary Page” provides a listing of drug names … Continue reading
Incivek telaprevir Drug Safety Communication
Incivek (telaprevir) In Combination with Drugs Peginterferon Alfa and Ribavirin (Incivek Combination Treatment): Drug Safety Communication – Serious Skin Reactions AUDIENCE: Internal Medicine, Gastroenterology, Dermatology ISSUE: FDA received reports of serious skin reactions, some fatal, in patients taking the … Continue reading
Posted in Dermatology, FDA Label Change, FDA Safety Communication, Gastroenterology, Internal Medicine
Tagged Dermatology, Drug Safety Communication, Gastroenterology, Incivek, Incivek telaprevir Drug Safety Communication, Internal Medicine, Peginterferon Alfa, Ribavirin, Serious Skin Reactions, telaprevir
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October 2012 Safety Labeling Changes
The MedWatch October 2012 Safety Labeling Changes posting includes 58 products with safety labeling changes to the following sections: CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT. The “Summary Page” provides a listing of drug names and safety labeling … Continue reading
Posted in FDA 2012, FDA Label Change, FDA Safety Communication
Tagged October 2012 Safety Labeling Changes
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September 2012 Safety Labeling Changes
The MedWatch September 2012 Safety Labeling Changes posting includes 60 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, FDA Safety Communication
Tagged drug risks, Drug Safety Communication, safety label changes
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August 2012 Safety Labeling Changes
The MedWatch August 2012 Safety Labeling Changes posting includes 53 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 and Lamictal XR, and Mirapex ER, Aplenzin, Artemether/Lumefantrine, atomoxetine hydrochloride, Atrovent HFA, August 2012, August 2012 Safety Labeling Changes, Avelox, Bactrim, Bactrim DS, Bupropion Hydrobromide, Capoten, Captopril, Cladribine, Coartem, Complera, Cyclosporine, Diovan HCT, Disoproxil Fumarate, drug risks, Drug Safety Communication, Edurant, efavirenz, Emtricitabine, Enfuvirtide, Etravirine, Fesoterodine Fumarate, Fuzeon, Intelence, Invega Sustenna, Ipratropium Bromide HFA, Isentress, Lamictal, Lamotrigine, Leustatin, Linagliptin, Lovaza, Lucentis, Maraviroc, Mirapex, Moviprep, Moxifloxacin Hydrochloride, Neoral oral Solution, Neoral Soft Gelatin, Nexavar, Norelgestromin/Ethinyl Estradiol, Omega-3-Acid Ethyl Esters, Optison, Ortho Evra, Oxaliplatin, Paliperidone Palmitrate, Panitumumab, PEG-3350, Perflutren Protein-Type A Microspheres Injectable Suspension, Potassium Chloride, pramipexole dihydrochloride, Raltegravir, Ranibizumab, Revatio, Rilpivirine, safety label changes, Safety Labeling Changes, Sanctura XR, Sandimmune, Selzentry, Sevoflurane, sildenafil, Sodium Ascorbate and Ascorbic Acid, Sodium Chloride, Sodium Sulfate, Sorafenib, Spectinomycin, Strattera, Sulfamethoxazole and Trimethoprim, Sustiva, Tenofovir Diovan, Tenofovir Disoproxil Fumarate, Toviaz, Tradjenta, Trobicin, trospium chloride, Ultane and Ultane NovaPlus, USP), valsartan, valsartan/hydrochlorothiazide, Vectibix, Viread
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MedWatch July 2012 Safety Labeling Changes
The MedWatch July 2012 Safety Labeling Changes posting includes 41 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, FDA Safety Communication
Tagged amlodipine/atorvastatin, anidulafungin, Avinza, AzaSite, azithromycin ophthalmic solution, Biaxin, buprenorphine, Butrans, Caduet, Capsules and Injection, clarithromycin, Dantrium, dantrolene sodium, Diovan, Dolophine, Drug Safety Communication, Duragesic, Embeda, emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg, Eraxis, Exalgo, Extended-Release Capsules, Extended-Release Oral Tablets, Extended-Release Tablets, FDA notice, Fentanyl Transdermal System, for Injection, hydromorphone HCl, July 2012, Kadian, MedWatch, MedWatch July 2012 Safety Labeling Changes, methadone hydrochloride, Methadone hydrochloride Oral Solution and Concentrate, Mirapex, MORPHINE SULFATE, morphine sulfate and naltrexone hydrochloride, Morphine Sulfate Controlled-Release, MS Contin, Natrecor, nesiritide, Nucynta ER, Opana ER, Oral Capsule, oxycodone hydrochloride controlled-release, Oxycontin, oxymorphone hydrochloride, Powder for Injection, pramipexole dihydrochloride, Prograf, safety label changes, Safety Labeling Changes, Sanctura, tablets, Tablets and Diovan HCT, tacrolimus, tapentadol, Transdermal System, trospium chloride, Truvada, valsartan, valsartan/hydrochlorothiazide
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June 2012 Safety Labeling Changes
The MedWatch June 2012 Safety Labeling Changes posting includes 35 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, FDA Safety Communication
Tagged 1.5% ophthalmic, atomoxetine hydrochloride, Avodart, azithromycin, bepotastine besilate, Bepreve, bismuth subsalicylate, CellCept, darunavir, Drug Safety Communication, dutasteride, dutasteride and tamsulosin HCL, efavirenz, Estraderm, Estradiol, FDA notice, Helidac Therapy, Human 10%, Incivek, Jalyn, June 2012 Safety Labeling Changes, lisinopril, lisinopril/hydrochlorothiazide, Methergine, methylergonovine maleate, metronidazole and tetracycline hydrochloride, mycophenolate mofetil, mycophenolate mofetil hydrochloride, mycophenolic acid, Myfortic, Noxafil, posaconazole, Prezista, Prinivil, Prinzide, Privigen Immune Globulin Intravenous, Safety Communication, safety label changes, solifenacin succinate, Stelara, Strattera, Sustiva, tablets, telaprevir, transdermal, ustekinumab, Vesicare, Zithromax
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