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” available via the link below provides a listing of drug names and safety labeling sections revised:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm315860.htm
The following drugs had modifications to the BOXED WARNINGS, CONTRAINDICATIONS and/or WARNINGS sections:
- 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
There are some very nasty drugs in this list. Remember, never have any drug unless it is absolutely necessary. Demand that any and every prescriber of a drug provides a completely satisfactory explanation to you about why you need a drug, what it is being prescribed to achieve, what risks it poses, what the likely side effects are, what serious side effects are possible and what alternatives exist.
Tags: FDA drug alerts, MedWatch