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Tag Archives: Safety Labeling Changes
MedWatch March 2013 Safety Labeling Changes
Translation 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 … Continue reading
February 2013 Safety Labeling Changes
TranslationThe MedWatch February 2013 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 2013, FDA Safety Communication
Tagged drug risks, FDA notice, February 2013, February 2013 Safety Labeling Changes, Safety Communication, safety label changes, Safety Labeling Changes
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MedWatch December 2012 Safety Labeling Changes
Translation 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
August 2012 Safety Labeling Changes
TranslationThe 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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Revatio sildenafil Drug Safety Communication
TranslationRevatio (sildenafil): Drug Safety Communication – Recommendation Against Use in Children AUDIENCE: Pediatrics, Cardiology, Pulmonology ISSUE: FDA notified healthcare professionals and their medical care organizations that Revatio (sildenafil) should not be prescribed to children (ages 1 through 17) for pulmonary … Continue reading
Posted in Cardiology, FDA 2012, FDA Safety Communication, FDA Warning, Pediatrics, Pulmonology
Tagged Cardiology, drug risks, Drug Safety Communication, FDA warning, PAH, Pediatrics, pulmonary arterial hypertension, Pulmonology, Revatio, Revatio sildenafil Drug Safety Communication, safety label changes, Safety Labeling Changes, sildenafil
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MedWatch July 2012 Safety Labeling Changes
TranslationThe 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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April 2012 Safety Labeling Changes
Translation The MedWatch April 2012 Safety Labeling Changes posting includes 43 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 … Continue reading
Posted in FDA 2012, FDA Label Change, FDA Safety Communication
Tagged Aceon, Advicor, Aliskiren, Aliskiren and Amlodipine, Aliskiren and Hydrochlorothiazide, Aliskiren and Valsartan, Altace, Altoprev, Amlodipine and Hydrochlorothiazide, Amturnide, April 2012, April 2012 Safety Labeling Changes, Atacand, Beyaz, Candesartan Cilexetil, Certolizumab Pegol, Cimzia, Conjugated Estrogens, Denosumab, Drospirenone and Ethinyl Estradiol, Drospirenone and Ethinyl Estradiol and Levomefolate Calcium, Drospirinenone and Ethinyl Estradiol, drug risks, Drug Safety Communication, egerid, Erlotinib, Estradiol, Everolimus, FDA notice, Insulin Detemir [rDNA origin], Itraconazole, Krystexxa, Levaquin, Levemir, Levofloxacin, liraglutide [rDNA], Lovastatin Extended-release, nelfinavir mesylate, Neupro, Niacin Extended-release/Lovastatin, Nutropin, Omeprazole and Sodium Bicarbonate, palivizumab, Pazopanib, Pegloticase, Perindopril Erbumine, Prandimet, Premarin, Ramipril, Repaglinide and Metformin HCL, Rotigotine, safety label changes, Safety Labeling Changes, Safyral, Somatropin [rDNA origin], Sporanox, Sunitinib Malate, Sutent, Synagis, Tarceva, Tekamlo, Tekturna, Tekturna HCT, USP), Vagifem, Valturna, Victoza, Viracept, Votrient, Xgeva, Yasmin, Yaz, Zortress
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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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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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