Drug Safety Labeling Changes - July 2009
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July 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 |
| Chantix (varenicline) 0.5 mg and 1 mg tablets |  | - | | | | - | - | - |
| Wellbutrin (bupropion hydrochloride) tablets, Sustained-Release, and Extended Release (XL) tablets | | - | | | - | - | - | - |
| Diabeta (glyburide) tablets | - | | | | | - | - | - |
| Lopid (gemfibrozil) tablets | - | | - | | - | - | - | - |
| Ortho Evra (norelgestromin / ethinyl estradiol) transdermal system | - | | | - | | - | - | - |
| Veramyst (fluticasone furoate) nasal spray | - | | | | | - | - | - |
| Actonel (risedronate sodium) tablets | - | - | | | - | - | - | - |
| Gardasil (Human Papillomavirus Quadrivalent Types 6, 11, 16, 18) Recombinant Vaccine | - | - | | | - | - | - | - |
| Letairis (ambrisentan) 5 and 10 mg tablets | - | - | | | - | - | - | - |
| Myfortic (mycophenolic acid) 180 mg and 360 mg delayed-release tablet | - | - | | - | | - | - | - |
| Drug Name |
BW |
C |
W |
P |
AR |
PPI |
MG |
PCI |
| Rilutek (riluzole) tablets | - | - | | | | - | - | - |
| Soliris (eculizumab) | - | - | | | | - | - | - |
| Abilify (aripiprazole) 9.75 mg / 1.3 mL (7.5 mg /mL) Injection | - | - | - | | - | - | - | - |
| Calan (verapamil hydrochloride) tablets | - | - | - | | - | - | - | - |
| Cardura (doxazosin mesylate) 1, 2, 4, and 8 mg tablets | - | - | - | | - | - | - | - |
| Geodon (ziprasidone) 20 mg, 40 mg, 60 mg, and 80 mg capsules and 20 mg base /mL injection | - | - | - | | - | - | - | - |
| Haldol (haloperidol) 5 mg base /mL injection and Haldol Decanoate (haloperidol) 50 mg base /mL and 100 mg base /mL IM injection | - | - | - | | - | - | - | - |
| Hytrin (terazosin hydrochloride) 1, 2, 5, and 10 mg tablets | - | - | - | | - | - | - | - |
| Invega (paliperidone) 1.5 mg, 3 mg, 6 mg, and 9 mg Extended-Release tablets | - | - | - | | - | - | - | - |
| Isoptin SR (verapamil HCL) 120 mg, 180 mg, and 240 mg Sustained Release tablets | - | - | - | | - | - | - | - |
| Drug Name |
BW |
C |
W |
P |
AR |
PPI |
MG |
PCI |
| Minipress (prazosin hydrochloride) 1, 2, and 5 mg capsules | - | - | - | | - | - | - | - |
| Moban (molindone) 5 mg, 10 mg, 25 mg, and 50 mg tablets | - | - | - | | - | - | - | - |
| Navane (thiothixene) 2 mg base/mL and 10 mg base/mL injectable | - | - | - | | - | - | - | - |
| Pamidronate disodium injection | - | - | - | | | - | - | - |
| Phisohex (hexachlorophene 3%) detergent cleanser | - | - | - | | - | - | - | - |
| Risperdal M-TAB (risperidone) 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg Orally Disintegrating tablets | - | - | - | | - | - | - | - |
| Alimta (pemetrexed disodium) Injection, Powder, Lyophilized for Intravenous Use 100 mg and 500 mg vial | - | - | - | - | | - | - | - |
| Caduet (amlodipine besylate/atorvastatin calcium) tablets | - | - | - | - | | - | - | - |
| Ditropan XL (oxybutynin chloride, USP) Extended Release tablets | - | - | - | - | | - | - | - |
| Femara (letrozole) 2.5 mg tablets | - | - | - | - | | - | - | - |
| Drug Name |
BW |
C |
W |
P |
AR |
PPI |
MG |
PCI |
| Isentress (raltegravir potassium) tablets | - | - | - | - | | - | - | - |
| Lovenox (enoxaparin sodium) injection | - | - | - | - | | - | - | - |
| Baraclude (entecavir) tablets and oral solution | - | - | - | - | - | | - | - |
