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The MedWatch March 2015 Safety Labeling Changes posting includes 67 products with safety labeling changes to the following sections:BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE.
The "Summary Page" table provides a listing of product names and safety labeling sections revised:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm441224.htm
The following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, or WARNINGS AND PRECAUTIONS sections:
Actonel (risedronate sodium) Tablets
Actonel with Calcium (risedronate sodium tablets with calcium carbonate) Tablets
Amturnide (aliskiren/amlodipine besylate/hydrochlorothiazide) Tablets
Aptivus (tipranavir) Capsules, Oral Solution
Atelvia (risedronate sodium) Delayed-release Tablets
Avandaryl (rosiglitazone maleate and glimepiride) Tablets
Breo Ellipta (fluticasone furoate and vilanterol) inhalation powder
Bydureon (exenatide extended-release) for Injectable Suspension
Cardizem LA (diltiazem hydrochloride) Extended Release Tablets
Cefobid (sterile cefoperazone) Injection
Cenestin (Synthetic Conjugated Estrogens, A) Tablets
Cordarone (amiodarone hydrochloride) Tablets
Crixivan (indinavir sulfate) Capsules
Dovonex (calcipotriene cream) Cream and Ointment
Duetact (pioglitazone hydrochloride and glimepiride) Tablets
Edex (alprostadil) for Injection
Ella (ulipristal acetate) Tablets
Erbitux (cetuximab) Injection for Intravenous Infusion
Estrasorb (estradiol) topical emulsion
Feraheme (ferumoxytol) Injection
Harvoni (ledipasvir/sofosbuvir) Fixed-dose Combination Tablet
Invirase (saquinavir mesylate) Capsules, Tablets
Kaletra (lopinavir/ritonavir) Oral Solution, Tablets, Capsules
Keppra (levetiracetam) Tablets, Oral Solution, Extended-release Tablets
Kyprolis (carfilzomib) for Injection
Lamictal (lamotrigine) Tablets, Chewable Dispersible Tablets, Orally Disintegrating Tablets, Extended-release Tablets
Lexiva (fosamprenavir calcium) Tablets, Oral Suspension
Minocin (minocycline hydrochloride) Pellet-filled Capsules
Nexterone (amiodarone) Premixed Injection
Norvir (ritonavir) Capsules, Oral Solution, Tablets
Pegasys (peginterferon alfa-2a) Injection, for Subcutaneous Use
Prezista (darunavir) Tablets, Oral Suspension
Reyataz (atazanavir) Capsules, Oral Powder
Sovaldi (sofosbuvir) Tablet
Tanzeum (albiglutide) Injection, for Subcutaneous Use
Tekamlo (aliskiren/amlodipine besylate) Tablets
Tekturna (aliskiren) Tablets
Tekturna HCT (aliskiren/hydrochlorothiazide) Tablets
Trulicity (dulaglutide) Injection, for Subcutaneous Use
Vectibix (panitumumab) Injection for Intravenous Infusion
Viagra (sildenafil citrate) Tablets, for Oral Use
Victoza (liraglutide [rDNA origin]) injection) Solution for Subcutaneous Use
Viracept (nelfinavir mesylate) Oral Powder, Tablets
Votrient (pazopanib) Tablets
Xeloda (capecitabine) Tablets
Ziagen (abacavir sulfate) Tablets, Oral Solution
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
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