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June 2013 Medication Safety Labeling Changes

medicationJune brought changes to forty-four (44) medical product labels (up slightly from 40 changes in May), with changes to the prescribing information to include any of the following areas: boxed warnings, contraindications, warnings, precautions, adverse reactions, patient package insert, and medication guide.

For a complete detailed accounting of the label changes, refer to the summary of meds. By clicking onto the drug name, you will be able to view the detailed summary, which will identify the safety labeling section and revised subsection, as well as a brief summary of the new or modified safety information.

The following medications have been affected:

Adderall XR (mixed amphetamine salts) capsules
Aldactone (spironolactone) Tablets
Aldactazide (spironolactone/HCTZ) Tablets
Azactam (aztreonam injection)in GALAXY Plastic Container and Azactam (aztreonam) for injection
Complera (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) tablets
Concerta (methylphenidate HCl) Extended-Release tablets
Daytrana (methylphenidate) transdermal system
Depacon (valproate sodium) Injection
Depakene (valproic acid) Capsules and Oral Solution, Depakote (divalproex sodium) Delayed Release and Depakote ER (Extended Release) Tablets, and Depakote Sprinkle Capsules
Dexedrine (dextroamphetamine sulfate) Spansule
Edurant (rilpivirine) tablet
Elaprase (idursulfase) injection
Exelon (rivastigmine) Patch
Eylea (aflibercept) Injection
Focalin (dexmethylphenidate hydrochloride) Tablets and Focalin XR (Extended-Release) Capsules
Fycompa (perampanel) Tablets
Immune Globulin Products (Human) intravenous, subcutaneous, and intramuscular
Istodax (romidepsin) lyophilized powder
Jentadueto (linagliptin and metformin hydrochloride) tablets
Lamisil (terbinafine hydrochloride) Tablets
Lamisil (terbinafine hydrochloride) Oral Granules
Metadate CD (methylphenidate HCl) Extended-Release Capsules
Methylin (methylphenidate HCl) Oral Solution and Chewable tablets
Mozobil (plerixafor) injection
Nordette (levonorgestrel/ethinyl estradiol) tablets
Ritalin (methylphenidate hydrochloride) Tablets, Ritalin SR (Extended-Release Tablets), and Ritalin LA (Extended-Release Capsules)
RotaTeq (Rotavirus Vaccine, Live, Oral, Pentavalent) Oral Solution
Stavzor (valproic acid) Delayed Release Capsules
Suprenza (phentermine hydrochloride) orally dissolving tablets
Tasigna (nilotinib) capsules
Tradjenta (linagliptin) tablets
Truvada (emtricitabine/tenofovir disoproxil fumarate) Tablets
Tykerb (lapatinib) tablets
Urso and Urso Forte (ursodiol) tablets
Vyvanse (lisdexamfetamine dimesylate) capsules
Welchol (colesevelam) Tablets and Oral Suspension