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Tag Archives: safety label 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
September 2012 Safety Labeling Changes
TranslationThe 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
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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Stryker Wingspan Stent System Safety Communication
Translation Stryker Wingspan Stent System: Safety Communication – Narrowed Indications for Use AUDIENCE: Neurology, Surgery, Patients ISSUE: The FDA is informing health care providers and patients that the indications for use and labeling for the Wingspan stent have … Continue reading
Posted in FDA 2012, FDA Safety Communication, Neurology, Patients, Surgery
Tagged Drug Safety Communication, FDA Recalls, FDA warning, Safety Communication, safety label changes, Stryker Wingspan Stent System
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June 2012 Safety Labeling Changes
TranslationThe 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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Cefepime Label Change drug risks
TranslationCefepime:Label Change- Risk of Seizure in Patients Not Receiving Dosage Adjustments for Kidney Impairment Audience: Health Professional,Infectious Disease, Nephrology Issue: There have been cases of a specific type of seizure called nonconvulsive status epilepticus associated with the use of … Continue reading
Posted in FDA 2012, FDA Warning, Healthcare Professionals, Infectious Disease, Nephrology
Tagged Adverse Effects, Cefepime, Cefepime Label Change, drug effects, drug reactions, drug risks, FDA warning, Health Professional, Infectious Disease, Nephrology, Risk of Seizure, safety label changes
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