April 2012 Drug Information Update - Pharmacy Benefits ...

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The following drugs had modifications to the BOXED WARNINGS, CONTRAINDICATIONS and WARNINGS sections: Monthly Safety Labeling Changes includes 65 products with revisions to Prescribing Information. Abilify (aripiprazole) Tablets, Orally Disintegrating Tablets, Oral Solution, and Injection Amturnide (amlodipine/aliskiren/hydrochlorothiazide) tablets Angeliq (drospirenone and estradiol) tablets Aptivus (tipranavir) Capsules and Oral Solution Avalide (irbesartan/hydrochlorothiazide) tablets Benicar (olmesartan medoxomil) Tablets Beyaz (drospirenone/ethinyl estradiol/levomefolate calcium tablets and levomefolate calcium) tablets Cardiogen-82 (Rubidium Rb 82 Generator) Crestor (rosuvastatin calcium) Tablets Crixivan (indinavir sulfate) Capsules Diovan HCT (valsartan/hydrochlorothiazide) Tablets EES (erythromycin ethylsuccinate) Granules for oral suspension, Eryc (erythromycin delayedrelease) capsules, Ery-Ped liquid and PCE (erythromycin particles in tablets) 333 mg and 500 mg film coated tablets Elestrin (estradiol gel) Exforge HCT (amlodipine/valsartan/hydrochlorothiazide) tablets Famvir (famciclovir) Tablets Hepsera (adefovir dipivoxil) tablets Invirase (saquinavir mesylate) Capsules and Tablets Kaletra (lopinavir/ritonavir) Tablets and Oral Solution Lescol (fluvastatin sodium) Capsules Lescol XL (fluvastatin sodium) Extended-Release Tablets Letairis (ambrisentan) Tablets Lexiva (fosamprenavir calcium) tablets and oral suspension Lipitor (atorvastatin calcium) Tablets Livalo (pitavastatin) tablets Lotensin HCT (benazepril HCl and hydrochlorothiazide) Tablets Mevacor (lovastatin) Tablets Natazia (estradiol valerate and estradiol valerate/dienogest) tablets Norvir (ritonavir) oral solution and tablets Orencia (abatacept) for injection Ozurdex (dexamethasone intravitreal) implant Patanase (olopatadine hydrochloride) Nasal Spray Phendimetrazine tartrate SR 105 mg capsules Pravachol (pravastatin sodium) Tablets Premarin (conjugated estrogens) Vaginal Cream Prempro (conjugated estrogens/medroxyprogesterone acetate tablets) and Premphase (conjugated strogens plus medroxyprogesterone acetate) tablets Prezista (darunavir), Oral suspension Reyataz (atazanavir sulfate) Capsules Rituxan (rituximab) Intravenous Injection Safyral (drospirenone/ethinyl estradiol/levomefolate calcium tablets and levomefolate calcium) tablets Simcor (niacin ER/simvastatin) Tablets Tekamlo (aliskiren/amlodipine) tablets Tekturna (aliskiren) and Tekturna HCT (aliskiren/hydrochlorothiazide) Tablets Valturna (aliskiren/valsartan) tablets Vaseretic (enalapril maleate/hydrochlorothiazide) Tablets Vasotec (enalapril maleate) Tablets Viracept (nelfinavir mesylate) Oral Powder 10
Vytorin (ezetimibe/simvastatin) Tablets Xalkori (crizotinib) Capsules Yasmin (drospirenone/ethinyl estradiol) tablets Zocor (simvastatin) Tablets Zyvox (linezoid) Tablets and Oral Suspension Article link: http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm294217.htm Source website: http://www.fda.gov/default.htm Argatroban Injection 50 mg/50 mL (1 mg/mL): Recall - Potential for Visible Particulates [Posted 03/23/2012] ISSUE: Eagle Pharmaceuticals Inc., supplier to The Medicines Company, issued a voluntary recall of all four (4) lots of Argatroban Injection, 50 mg per 50 mL from the market due to a potential for visible particulates. The risk of using an injectable product with particulates includes embolization/ infarction to organs and potential organ complications. BACKGROUND: During an investigation, a visible particulate was discovered in a stability sample in one of the distributed lots. This discovery prompted a re-inspection of undistributed lots at the manufacturing site. Upon this re-inspection, a small number of visible particulates were discovered in several vials. The affected products include: NDC# 42367-203-07 (single unit), NDC# 42367-203-84 (10 pack) RECOMMENDATION: Eagle Pharmaceuticals Inc. directed The Medicines Company to arrange for the return of the affected product lots from all services and facilities. See the Press Release for a listing of affected lots. Article link: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ Source website: http://www.fda.gov/default.htm Celexa (citalopram hydrobromide) - Drug Safety Communication: Revised Recommendations, Potential Risk of Abnormal Heart Rhythms [Posted 03/28/2012] ISSUE: FDA is clarifying dosing and warning recommendations for the antidepressant Celexa (citalopram hydrobromide; also available in generic form). In August 2011, FDA issued a Drug Safety Communication (DSC) stating that citalopram should no longer be used at doses greater than 40 mg per day because it could cause potentially dangerous abnormalities in the electrical activity of the heart. Citalopram use at any dose is discouraged in patients with certain conditions because of the risk of QT prolongation, but because it may be important for some of those patients to use citalopram, the drug label has been changed to describe the particular caution that needs to be taken when citalopram is used in such patients. The revised drug label also describes lower doses that should be used in patients over 60 years of age. BACKGROUND: Celexa (citalopram hydrobromide; also available in generic form) is in a class of antidepressants called selective serotonin reuptake inhibitors (SSRIs). RECOMMENDATIONS: • Citalopram is not recommended for use at doses greater than 40 mg per day because such doses cause too large an effect on the QT interval and confer no additional benefit. • Citalopram is not recommended for use in patients with congenital long QT syndrome, bradycardia, hypokalemia, or hypomagnesemia, recent acute myocardial infarction, or uncompensated heart failure. • Citalopram use is also not recommended in patients who are taking other drugs that prolong the QT interval. • The maximum recommended dose of citalopram is 20 mg per day for patients with hepatic impairment, patients who are older than 60 years of age, patients who are CYP 2C19 poor metabolizers, or patients who are taking concomitant cimetidine (Tagamet) or another CYP2C19 inhibitor, because these factors lead to increased blood levels of citalopram, increasing the risk of QT interval prolongation and Torsade de Pointes. 11
Page 1 and 2: April 2012 Drug Information Update
Page 3 and 4: First-Time Generics GENERIC DRUG NA
Page 5 and 6: GENERAL ANESTHETICS, INJECTABLE MID
Page 7 and 8: Gruenhaupt, Mark R.Ph. Argus Health
Page 9: Statin Drugs - Drug Safety Communic
Page 13 and 14: low blood sugar (hypoglycemia) in p
Page 15 and 16: Some women with depression who beco
Page 17 and 18: Survival increased for all groups o
Page 19 and 20: finding that it also may reduce the
Page 21 and 22: Syringes (2 mL size), Rx only. NDC
Page 23 and 24: Patheon Pharmaceuticals Inc., Cinci
Page 25 and 26: 50-ct. bottles (NDC 0067-6238-50);
Page 27 and 28: PRODUCT (Class II) 1) Ventolin HFA
Page 29 and 30: Lot #: 0693, Exp: 10/2012 RECALLING
Page 31 and 32: 24 (Display case UPC# 3030045074923
Page 33 and 34: CODE Lot # 139961 RECALLING FIRM/MA
Page 35 and 36: Reason for the Shortage • Teva co
Page 37 and 38: Reason for the Shortage • Ben Ven
Page 39 and 40: Products Affected - Description Gan
Page 41 and 42: 37.5 mg/25 mg, 1000 count (NDC 0078
Page 43 and 44: Acyclovir tablets, Major 400 tablet
Page 45 and 46: 500 mg, 100 count (NDC 63304-0726-0
Page 47 and 48: 750 mg tablets, 100 count (NDC 1013
Page 49 and 50: • Bedford Laboratories has multip
Page 51 and 52: Daunorubicin Hydrochloride Injectio
Page 53 and 54: Ciprofloxacin Immediate-Release Tab
Page 55 and 56: • APP had tobramycin 40 mg/mL pre
Page 57 and 58: • Ben Venue voluntarily suspended
Page 59 and 60: 50 mg/mL, 10 mL vial, package of 10
Page 61 and 62:
2 mL vial, preservative-free (NDC 6
Page 63 and 64:
5 mg single dose vial, package of 1
Page 65 and 66:
20 mL glass ampule, sterile pack (N
Page 67 and 68:
2 mL iSecure syringe (NDC 00406-112
Page 69 and 70:
Lidocaine 0.5% Xylocaine 0.5% injec
Page 71 and 72:
• Teva discontinued all ciproflox
Page 73 and 74:
Nicardipine hydrochloride injection
Page 75 and 76:
Article link: http://www.ashp.org/D
Page 77 and 78:
• Apotex had metformin products u
Page 79:
• Covis purchased all rights to F
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