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.

This content was submitted directly to this website by the supplier.

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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