Drug Safety Labeling Changes - February 2008

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February 2008

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
Atripla (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) TabletsBoxed Warning-WarningsPrecautionsAdverse ReactionsPatient Package Insert--
Cleocin Sterile Solution (clindamycin injection)Boxed Warning-WarningsPrecautions----
Cleocin Phosphate (clindamycin injection in 5% dextrose) IV Sterile SolutionBoxed Warning-WarningsPrecautions----
Duragesic (fentanyl) Transdermal SystemBoxed Warning-WarningsPrecautions----
Emsam (selegiline transdermal system) PatchesBoxed Warning-WarningsPrecautions----
Fentora (fentanyl buccal tablet)Boxed Warning-------
Lincocin (lincomycin) InjectionBoxed Warning-WarningsPrecautions----
Asmanex Twisthaler (mometasone furoate inhalation powder)-ContraindicationsWarningsPrecautionsAdverse Reactions---
Abilify (aripiprazole) Tablets and Oral Solution--WarningsPrecautionsAdverse Reactions---
Abilify (aripiprazole) Discmelt Orally Disintegrating Tablets--WarningsPrecautionsAdverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Abilify (aripiprazole) Injection for Intramuscular Use Only--WarningsPrecautionsAdverse Reactions---
Avastin (bevacizumab) for Intravenous Use--Warnings-Adverse Reactions---
Claforan Sterile (cefotaxime sodium for injection, USP) and Injection (cefotaxime sodium injection, USP)--WarningsPrecautions----
Cortenema (hydrocortisone retention enema)--WarningsPrecautions----
Doryx (doxycycline hyclate) Capsule, Delayed Release Pellets--WarningsPrecautions----
Eryc (erythromycin delayed-release capsules, USP)--WarningsPrecautions----
Erythrocin Lactobinate (erythromycin lactobionate) Injection, Powder, Lyophilized, For Solution--WarningsPrecautions----
Geocillin (carbenicillin indanyl sodium) Tablets--WarningsPrecautions----
Halcion (triazolam tablets)--WarningsPrecautions----
Janumet (sitagliptin/metformin HCl) Tablets--WarningsPrecautions-Patient Package Insert--
Drug Name BW C W P AR PPI MG PCI
Premarin Intravenous (conjugated estrogens, USP) for injection--WarningsPrecautionsAdverse ReactionsPatient Package Insert--
Remodulin (treprostinil sodium) Injection--Warnings-Adverse Reactions---
Restoril (temazepam) Capsules--WarningsPrecautions----
Reyataz (atazanavir sulfate) Capsules--Warnings-Adverse ReactionsPatient Package Insert--
Sensipar (cinacalcet) Tablets--WarningsPrecautionsAdverse Reactions---
Ultram ER (tramadol HCl) Extended-Release Tablets--WarningsPrecautionsAdverse Reactions---
Vibramycin Calcium (doxycycline calcium oral suspension, USP) Oral Suspension Syrup--WarningsPrecautions----
Vibramycin Hyclate (doxycycline hyclate capsules, USP) Capsules--WarningsPrecautions----
Vibramycin Monohydrate (doxycycline monohydrate) for Oral Suspension--WarningsPrecautions----
Vibra-Tabs (doxycycline hyclate tablets, USP) Film Coated Tablets--WarningsPrecautions----
Drug Name BW C W P AR PPI MG PCI
Arestin (minocycline HCl) Microspheres---Precautions----
Avelox (moxifloxacin HCl) Tablets---PrecautionsAdverse ReactionsPatient Package Insert--
Avelox I.V. (moxifloxacin HCl in NaCl injection)---PrecautionsAdverse ReactionsPatient Package Insert--
Corgard (nadolol tablets, USP)---Precautions----
Daytrana (methylphenidate transdermal system)---PrecautionsAdverse Reactions---
Diskets Dispersible Tablets (methadone hydrochloride tablets for oral suspension, USP) ---Precautions----
Ditropan (oxybutynin chloride) Tablets and Syrup---PrecautionsAdverse Reactions---
Effexor (venlafaxine hydrochloride) Tablets---Precautions----
Effexor XR (venlafaxine hydrochloride) Extended-Release Capsules---Precautions----
Lexiva (fosamprenavir calcium) Tablets and Oral Suspension---Precautions----
Drug Name BW C W P AR PPI MG PCI
Methadose Sugar-Free Oral Concentrate (methadone hydrochloride oral concentrate USP)---Precautions----
Nexium (esomeprazole magnesium) Delayed-Release Capsules---PrecautionsAdverse Reactions---
Nexium (esomeprazole magnesium) For Delayed-Rlease Oral Suspension---PrecautionsAdverse Reactions---
Tekturna (aliskren) Tablets---Precautions----
Trandate (labetalol hydrochloride) Tablets---Precautions----
Viracept (nelfinavir mesylate) Tablets and Oral Powder---Precautions----
Forteo teriparatide (rDNA origin) Injection----Adverse Reactions---
MoviPrep (polyethylene glycol 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid) Oral Solution----Adverse Reactions---
Viagra (sildenafil citrate) Tablets----Adverse Reactions---
Vytorin (ezetimibe/simvastatin tablets)----Adverse ReactionsPatient Package Insert--
Drug Name BW C W P AR PPI MG PCI
Zetia (ezetimibe) Tablets----Adverse ReactionsPatient Package Insert--
Avandia (rosiglitazone maleate tablets)--------
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