Drug Safety Labeling Changes - June 2012

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June 2012

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
CellCept (mycophenolate mofetil) Capsules, Tablets, Oral SuspensionBoxed Warning-WarningsPrecautions----
CellCept (mycophenolate mofetil hydrochloride) for injection IntravenousBoxed Warning-WarningsPrecautions----
Estraderm (estradiol) transdermal systemBoxed WarningContraindicationsWarningsPrecautions----
Prinivil (lisinopril) tablets and Prinzide(lisinopril/hydrochlorothiazide) tabletsBoxed Warning-WarningsPrecautions----
Bepreve (bepotastine besilate) 1.5% ophthalmic solution-Contraindications--Adverse Reactions---
Noxafil (posaconazole) Oral Suspension-Contraindications------
Avodart (dutasteride) Soft Gelatin Capsules--WarningsPrecautions----
Helidac Therapy (bismuth subsalicylate, metronidazole tablet and tetracycline hydrochloride) capsule--Warnings-Adverse Reactions---
Incivek (telaprevir) film-coated tablets--WarningsPrecautions----
Jalyn (dutasteride and tamsulosin HCL) capsules--WarningsPrecautions----
Drug Name BW C W P AR PPI MG PCI
Methergine (methylergonovine maleate) tablet and injection--WarningsPrecautionsAdverse Reactions---
Prezista (darunavir) tablets and oral--WarningsPrecautionsAdverse ReactionsPatient Package Insert--
Privigen Immune Globulin Intravenous (Human) 10% Liquid--WarningsPrecautions----
Vesicare (solifenacin succinate)--WarningsPrecautions----
Zithromax (azithromycin) Single Dose Packet--WarningsPrecautions----
Zithromax (azithromycin) for Oral Suspension--WarningsPrecautions----
Zithromax (azithromycin) 200 mg Tablet--WarningsPrecautions----
Zithromax (azithromycin) 600 mg Tablet--WarningsPrecautions----
Zithromax IV (azithromycin for injection)--WarningsPrecautions----
Zithromax (azithromycin) 500 mg Tablet--WarningsPrecautions----
Drug Name BW C W P AR PPI MG PCI
Ortho-Cept (desogestrel and ethinyl estradiol) Tablets---Precautions----
Ortho-Cyclen (norgestimate/ethinyl estradiol) Tablets---Precautions----
Ortho-Novum (norethindrone/ethinyl estradiol) 1/35 Tablets---Precautions----
Ortho-Novum (norethindrone/ethinyl estradiol) 7/7/7 Tablets---Precautions----
Ortho Tri-Cyclen (norgestimate/ethinyl estradiol) Tablets---Precautions----
Ortho Tri-Cyclen Lo (norgestimate/ethinyl estradiol) Tablet---Precautions----
Treanda (bendamustine hydrochloride) Lyophilized Solid for Injection---Precautions----
Visudyne (verteporfin) for injection---PrecautionsAdverse Reactions---
Zyflo (zileuton) Tablets---Precautions----
Alimta (pemetrexed for injection) Lyophilized Powder, for solution form intravenous use vials----Adverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Dopamine HCl in 5% Dextrose Injection, USP in plastic container----Adverse Reactions---
Increlex (mecasermin [rDNA origin]) injection----Adverse Reactions---
Proventil HFA (albuterol sulfate) Inhalation Aerosol----Adverse Reactions---
Intron A   (Interferon alfa-2b, recombinant)--------
PegIntron  (Peginterferon alfa-2b)--------
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