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July 2012 Medication Label Changes

Last month brought changes to forty-one (41) medical product labels (up from 35 changes in June), 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 can view the detailed summary which will identify the safety labeling section and revised subsection, and a brief summary of the new or modified safety information.

The following medications have been affected:

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