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The MedWatch April 2014 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" provides a listing of product names and safety labeling sections revised:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm396456.htm
The following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS and PRECAUTIONS sections:
Avinza (morphine sulfate)
Butrans (buprenorphine) Transdermal System
Dolophine (methadone hydrochloride)
Duragesic (fentanyl transdermal system)
Embeda (morphine sulfate and naltrexone hydrochloride)
Exalgo (hydromorphone HCl)
Kadian (morphine sulfate)
MS Contin (morphine sulfate)
Nucynta ER (tapentadol)
Opana ER (oxymorphone hydrochloride)
Oxycontin (oxycodone hydrochloride)
Palladone (hydromorphone hydrochloride)
Aptivus (tipranavir)
VFEND (voriconazole)
Adcirca (tadalafil)
Benlysta (belimumab)
Cialis (tadalafil)
Delflex Peritoneal Dialysis (PD) Solutions
Excedrin Migraine (acetaminophen 250 mg, aspirin 250 mg, caffeine 65 mg)
Gilenya (fingolimod)
Kuvan (sapropterin dihydrochloride)
Levitra (vardenafil hydrochloride)
Oncaspar (pegaspargase)
Prezista (darunavir)
Sprycel (dasatinib)
Staxyn (vardenafil hydrochloride)
Stendra (avanafil)
Suboxone (buprenorphine and naloxone)
Tarceva (erlotinib)
Torisel Kit (temsirolimus)
Viibryd (vilazodone hydrochloride)
Zometa (zoledronic acid)
Cleocin T (clindamycin phosphate)
Dilantin - 125 (phenytoin)
Dulera (mometasone furoate/formoterol fumarate)
Fanapt (iloperidone)
Invega (paliperidone)
Isentress (raltegravir)
Nitrostat (nitroglycerin USP)
Sprix (ketorolac tromethamine)
TOBI Podhaler (tobramycin inhalation powder)
TOBI (tobramycin inhalation solution, USP)
Trental (pentoxifylline)
Xyrem (sodium oxybate)
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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