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The MedWatch December 2009 Drug Safety Labeling Changes posting includes 28 drug products with safety labeling changes to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERT, and MEDICATION GUIDE.
The "Summary Page" provides a listing of drug names and safety labeling sections revised:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm194965.htm
Clicking on a drug product name in the Summary View will take you to the "detailed view" page, which identifies safety labeling sections and subsections revised, along with a brief summary of new or modified safety information to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections.
The following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, and WARNINGS sections:
- Arixtra (fondaparinux sodium)
- Fragmin (dalteparin sodium)
- Innohep (tinzaparin sodium)
- Lovenox (enoxaparin sodium)
- Actonel (risedronate sodium)
- Amlodipine besylate/ Benazepril hydrochloride capsule
- Didronel (etidronate disodium)
- Innopran XL (propranolol hydrochloride)
- Ortho Evra (norelgestromin and ethinyl estradiol)
- Spiriva HandiHaler (tiotropium bromide)
- Arranon (nelarabine)
- Bicillin L-A (penicillin G benzathine) and Bicillin CR (penicillin G benzathine and penicillin G procaine)
- Daytrana (methylphenidate)
- Janumet (sitagliptin/metformin HCl)
- Januvia (sitagliptin)
- Lexiscan (regadenoson)
- Seroquel (quetiapine fumarate)
- Seroquel XR (quetiapine fumarate)
- Topamax (topiramate)
- Velcade (bortezomib)
- Verelan PM (verapamil hydrochloride)
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