Drug Safety Labeling Changes - June  2012

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Food and Drug Administration (FDA) announces important safety label changes for prescription drugs almost every month. By implementing the label changes the FDA warns a physician of new side- effects, adverse reactions, contra-indications and precautions necessary for a drug. This information is important for safe practice of medicine.

Key to Label Sections

  • C - Contraindications
  • W - Warnings
  • P - Precautions
  • AR - Adverse Reactions

Drug Name Sections Modified
C W P AR
Albuterol (Salbutamol) - - -
Atomoxetine
Azithromycin - -
Bendamustine hydrochloride - - -
Bepotastine - -
Darunavir -
Desogestrel and Ethinyl Estradiol - - -
Dopamine - - -
Dutasteride - -
Dutasteride And Tamsulosin - -
Efavirenz - -
Estradiol -
Helidac Therapy (bismuth subsalicylate, metronidazole tablet and tetracycline hydrochloride) capsule - -
Interferon Alpha- Two B - - - -
Lisinopril - -
Mecasermin [rDNA origin] Injection - - -
Methergine (methylergonovine maleate) tablet and injection -
Modicon (norethindrone/ethinyl estradiol) - - -
Mycophenolatemofetil - -
Myfortic (mycophenolic acid) delayed-release tablets - -
Norfloxacin - - -
Norgestimate and ethinyl estradiol - - -
Noxafil (posaconazole) Oral Suspension - - -
Ortho Tri-Cyclen (norgestimate/ethinyl estradiol) Tablets - - -
Ortho Tri-Cyclen Lo (norgestimate/ethinyl estradiol) Tablet - - -
Ortho-Novum (norethindrone/ethinyl estradiol) 1/35 Tablets - - -
Ortho-Novum (norethindrone/ethinyl estradiol) 7/7/7 Tablets - - -
Peginterferon Alfa 2 B - - - -
Pemetrexed - - -
Privigen Immune Globulin Intravenous (Human) 10% Liquid - -
Solifenacin - -
Telaprevir - -
Ustekinumab -
Verteporfin - -
Zileuton - - -

2016 - Monthly Summary Report for Drug Label Changes

2015 - Monthly Summary Report for Drug Label Changes

2014 - Monthly Summary Report for Drug Label Changes

2013 - Monthly Summary Report for Drug Label Changes

2012 - Monthly Summary Report for Drug Label Changes

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