Published on:

August 2012 Medication Label Changes

Last month brought changes to fifty-three (53) medical product labels (way up from 41 changes in July), with changes to the prescribing information to include any of the following areas: boxed warnings, contraindications, warnings, precautions, adverse reactions, patient package insert, and medication guide.
For a complete detailed accounting of the label changes, please refer to the summary of meds. By clicking onto the drug name, you will be able to view the detailed summary, which will identify the safety labeling section and revised subsection, as well as a brief summary of the new or modified safety information.
The following medications have been affected:
Aplenzin (Bupropion Hydrobromide)
Atrovent HFA (Ipratropium Bromide HFA)
Avelox (Moxifloxacin Hydrochloride)
Bactrim (Sulfamethoxazole and Trimethoprim)
Capoten (Captopril)
Coartem (Artemether/Lumefantrine)
Complera (Emtricitabine, Rilpivirine, Tenofovir
Diovan (Valsartan)Bactrim DS (Sulfamethoxazole and Trimethoprim)
Diovan HCT (Valsartan/Hydrochlorothiazide)
Disoproxil Fumarate)
Edurant (Rilpivirine)
Fuzeon (Enfuvirtide)
Intelence (Etravirine)
Invega Sustenna (Paliperidone Palmitrate)
Isentress (Raltegravir)
Lamictal (Lamotrigine) and Lamictal XR (Lamotrigine)
Leustatin (Cladribine)
Lovaza (Omega-3-Acid Ethyl Esters)
Lucentis (Ranibizumab)
Mirapex (Pramipexole Dihydrochloride) and Mirapex ER (Pramipexole Dihydrochloride)
Moviprep (PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate and Ascorbic Acid)
Neoral Soft Gelatin (Cyclosporine)
Neoral oral Solution (Cyclosporine)
Nexavar (Sorafenib)
Optison (Perflutren Protein-Type A Microspheres Injectable Suspension, USP)
Ortho Evra (Norelgestromin/Ethinyl Estradiol)
Oxaliplatin (Oxaliplatin)
Revatio (Sildenafil)
Sanctura XR (Trospium Chloride)
Sandimmune (Cyclosporine, USP)
Selzentry (Maraviroc)
Strattera (Atomoxetine Hydrochloride)
Sustiva (Efavirenz)
Toviaz (Fesoterodine Fumarate)
Tradjenta (Linagliptin)
Trobicin (Spectinomycin)
Ultane and Ultane NovaPlus (Sevoflurane)
Vectibix (Panitumumab)
Viread (Tenofovir Disoproxil Fumarate

Posted in:
Published on:
Updated: