The 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 safety labeling sections revised:



The following drugs had modifications to the BOXED WARNINGS, CONTRAINDICATIONS and/or WARNINGS sections:


Avinza (morphine sulfate) Extended-Release Capsules
Butrans (buprenorphine) Transdermal System
Dantrium (dantrolene sodium) Oral Capsule
Dolophine (methadone hydrochloride) Tablets
Duragesic (Fentanyl Transdermal System)
Embeda (morphine sulfate and naltrexone hydrochloride) Extended-Release Capsules
Exalgo (hydromorphone HCl) Extended-Release Tablets
Kadian (morphine sulfate) Extended-Release Capsules
Methadone hydrochloride Oral Solution and Concentrate
MS Contin (Morphine Sulfate Controlled-Release) Tablets
Nucynta ER (tapentadol) Extended-Release Oral Tablets
Opana ER (oxymorphone hydrochloride) Extended-Release Tablets
Oxycontin (oxycodone hydrochloride controlled-release) Tablets
Truvada (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg)
AzaSite (azithromycin ophthalmic solution)
Biaxin (clarithromycin)
Diovan (valsartan) Tablets and Diovan HCT (valsartan/hydrochlorothiazide)
Caduet (amlodipine/atorvastatin) Tablets
Eraxis (anidulafungin) Powder for Injection
Mirapex (pramipexole dihydrochloride)
Natrecor (nesiritide) for Injection
Prograf (tacrolimus) Capsules and Injection
Sanctura (trospium chloride)
Strattera (atomoxetine hydrochloride) capsules
Zinecard (dexrazoxane) for injection
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