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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:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm314601.htm
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
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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