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” available via the link below 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
Always remember that ALL prescribed medicines are dangerous. Only prescribe or consume them if truly necessary. There are always adverse effects when taking drugs and not all are documented. If you have any unwanted reactions or responses to medication be sure to make a report.
Tags: FDA MedWatch