December 2009 Drug Safety Labeling Changes

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.

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Jan 14th, 2010

The "Summary Page" provides a listing of drug names and safety labeling sections revised:

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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