Drug Safety Labeling Changes - December 2009

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December 2009

This monthly summary of drug label changes provides a quick view of the sections that have changed. Click on a drug name to view the changes in more detail.

Key to Label Sections
BW - Boxed Warning C - Contraindications W - Warnings P - Precautions
AR - Adverse Reactions PPI - Patient Package Insert MG - Medication Guide PCI - Patient Counseling Information

Sections Modified
Drug Name BW C W P AR PPI MG PCI
Lovenox (enoxaparin sodium) injectionBoxed Warning-------
Actonel (risedronate sodium) tablets-ContraindicationsWarningsPrecautions----
Amlodipine besylate/ Benazepril hydrochloride capsule-Contraindications-Precautions----
Didronel (etidronate disodium) tablets-ContraindicationsWarningsPrecautions----
Innopran XL (propranolol hydrochloride) extended release capsules-Contraindications-Precautions----
Ortho Evra (norelgestromin and ethinyl estradiol) transdermal system-Contraindications-PrecautionsAdverse ReactionsPatient Package Insert--
Spiriva HandiHaler (tiotropium bromide) inhalation powder-ContraindicationsWarningsPrecautions----
Bicillin L-A (penicillin G benzathine) and Bicillin CR (penicillin G benzathine and penicillin G procaine) injectable suspensions--WarningsPrecautions----
Janumet (sitagliptin/metformin HCl) tablets --WarningsPrecautionsAdverse Reactions---
Topamax (topiramate) tablets and sprinkle capsules--WarningsPrecautions----
Drug Name BW C W P AR PPI MG PCI
Velcade (bortezomib) for injection--WarningsPrecautions----
Verelan PM (verapamil hydrochloride) Extended-Release capsules--WarningsPrecautionsAdverse Reactions---
Flomax (tamsulosin hydrochloride) capsules---Precautions----
Zyvox (linezolid) tablets, IV injection, and oral suspension---PrecautionsAdverse Reactions---
Invanz (ertapenem) injection----Adverse Reactions---
Zestril (lisinopril) tablets----Adverse Reactions---
Ziac (bisoprolol fumarate and hydrochlorothiazide) tablets----Adverse Reactions---
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