June 2012 Drug Information Update - Pharmacy Benefits ...

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antiarrhythmic medications. In addition, FDA is now also recommending that the time of cardiovascular monitoring be extended past 6 hours in patients who are at higher risk for or who may not tolerate bradycardia. Extended monitoring should include continuous ECG monitoring that continues overnight. Healthcare professionals are encouraged to review the updated drug label for Gilenya, and note specific FDA recommendations for monitoring patients and the new contraindications for use in certain patients. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm28 4355.htm Source website: http://www.fda.gov/default.htm The MedWatch April 2012 Safety Labeling Changes posting includes 43 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT. [Updated 05/14/2012] The "Summary Page" provides a listing of drug names and safety labeling sections revised: http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm302285.htm The following drugs had modifications to the BOXED WARNINGS, CONTRAINDICATIONS and WARNINGS sections: Aceon (Perindopril Erbumine) Altace (Ramipril) Atacand (Candesartan Cilexetil) Sporanox (Itraconazole) Zortress (Everolimus) Advicor (Niacin Extended-release/Lovastatin) Altoprev (Lovastatin Extended-release) Amturnide (Aliskiren, Amlodipine and Hydrochlorothiazide) Premarin (Conjugated Estrogens,USP) Tekamlo (Aliskiren and Amlodipine) Tekturna (Aliskiren) Tekturna HCT (Aliskiren and Hydrochlorothiazide) Vagifem (Estradiol) Valturna (Aliskiren and Valsartan) Viracept (nelfinavir mesylate) Beyaz (Drospirenone and Ethinyl Estradiol and Levomefolate Calcium) Cimzia (Certolizumab Pegol) Krystexxa (Pegloticase) Levaquin (Levofloxacin) Levemir (Insulin Detemir [rDNA origin]) Neupro (Rotigotine) Nutropin (Somatropin [rDNA origin]) Prandimet (Repaglinide and Metformin HCL) Safyral (Drospirenone and Ethinyl Estradiol and Levomefolate Calcium) Sutent (Sunitinib Malate) Synagis (palivizumab) Tarceva (Erlotinib) Victoza (liraglutide [rDNA]) Votrient (Pazopanib) Xgeva (Denosumab) Yasmin (Drospirenone and Ethinyl Estradiol) Yaz (Drospirinenone and Ethinyl Estradiol) Zegerid (Omeprazole and Sodium Bicarbonate) Article link: http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm302285.htm?source=govdelivery 8
Source website: http://www.fda.gov/default.htm FDA Statement regarding azithromycin (Zithromax) and the risk of cardiovascular death [Posted 05/17/2012] The U.S. Food and Drug Administration (FDA) is aware of the study published in the New England Journal of Medicine, on May 17, 20121, that compared the risks of cardiovascular death in patients treated with azithromycin (Zithromax), amoxicillin, ciprofloxacin (Cipro), levofloxacin (Levaquin), and no antibacterial drug. The study reported a small increase in cardiovascular deaths, and in the risk of death from any cause, in persons treated with a 5-day course of azithromycin (Zithromax) compared to persons treated with amoxicillin, ciprofloxacin, or no drug. The risks of cardiovascular death associated with levofloxacin treatment were similar to those associated with azithromycin treatment. FDA is reviewing the results from this study and will communicate any new information that results from the FDA review. Patients taking azithromycin should not stop taking their medicine without talking to their healthcare professional. Healthcare professionals should be aware of the potential for QT interval prolongation and heart arrhythmias when prescribing or administering antibacterial drugs. (See additional information below.) Azithromycin belongs to a class of antibacterial drugs called macrolides, which have been associated with cardiovascular effects; specifically, prolongation of the QT interval. Prolongation of the QT interval can lead to torsades de pointes (TdP), an abnormal heart rhythm, which can be fatal. Azithromycin was the only macrolide examined in the published study; the study did not address other macrolide antibacterial drugs, such as clarithromycin (Biaxin) and erythromycin, regarding the potential for cardiovascular death. In 2011, FDA reviewed macrolide drug labeling information related to QT interval prolongation and TdP. The WARNINGS AND PRECAUTIONS section of the Zmax drug label (azithromycin extended release for oral suspension) was revised in March 2012 to include new information regarding risk for QT interval prolongation, which appears to be low. The drug labels for clarithromycin and erythromycin also contain information about QT interval prolongation in the WARNINGS section. FDA is in the process of updating risk information in the drug labels for additional macrolide antibacterial drugs. FDA-approved indications for azithromycin include: Acute bacterial exacerbations of chronic pulmonary disease Acute bacterial sinusitis Community-acquired pneumonia Pharyngitis/tonsillitis Uncomplicated skin and skin structure infections Urethritis and cervicitis Genital ulcer disease FDA will communicate any new information on azithromycin and this study or the potential risk of QT interval prolongation after the agency has completed its review. Article link: http://www.fda.gov/Drugs/DrugSafety/ucm304372.htm Source website: http://www.fda.gov/default.htm Studies Strokes Follow Xarelto to Warfarin Switch April 26, 2012 Atrial fibrillation patients who transition from rivaroxaban (Xarelto) to a vitamin K antagonist may have an increased risk of stroke, a subanalysis of the ROCKET-AF trial found. At the completion of the trial, the risk of stroke for those moving off rivaroxaban was 6.42 per 100 patient-years compared with 1.73 per 100 patient-years for those on warfarin, Jonathan P. Piccini, MD, from Duke University Medical Center, and colleagues reported during an American 9
Page 1 and 2: June 2012 Drug Information Update
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Page 5 and 6: ANTI-DIARRHEALS OPIUM TINCTURE DISP
Page 7: indicated for the treatment of HIV-
Page 11 and 12: Testosterone Chases Viagra in Libid
Page 13 and 14: Analytical Trend Troubles Scientist
Page 15 and 16: Testosterone supplements may help m
Page 17 and 18: voted 19-3 to endorse the drug's us
Page 19 and 20: New Drug Trial Seeks to Stop Alzhei
Page 21 and 22: translates into a 38 percent reduct
Page 23 and 24: atypical fractures of the thigh bon
Page 25 and 26: contain Sibutramine, an appetite su
Page 27 and 28: 2 fl oz UPC 011673257424. Recall #
Page 29 and 30: NDC 5816082101 (single dose vial);
Page 31 and 32: Manufacturer: Catalent Argentina S.
Page 33 and 34: • Fera cannot provide a reason fo
Page 35 and 36: • Akorn states the reason for the
Page 37 and 38: Reason for the Shortage • Teva st
Page 39 and 40: 15 gram Novaplus bulk vial, 1 count
Page 41 and 42: Milrinone Injection May 9, 2012 Pro
Page 43 and 44: • Ranbaxy has all discontinued me
Page 45 and 46: Doxorubicin Liposomal Injection May
Page 47 and 48: 1 mg/mL, 2 mL vial, 25 count (NDC 6
Page 49 and 50: • APP has leucovorin on shortage
Page 51 and 52: • West-Ward acquired Baxter’s o
Page 53 and 54: • Ethinyl estradiol/norethindrone
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the gray market. • Ferring has No
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Source website: www.ashp.org Loraze
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Fentanyl Injection 50 mcg/mL, Hospi
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Bupivacaine Injection May 17, 2012
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Article link: http://www.ashp.org/D
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Heparin Sodium Injection May 18, 20
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o Heparin sodium 10 unit/mL, 5 mL l
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Article link: http://www.ashp.org/D
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• Amphastar and Baxter have disco
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Fludarabine Injection May 21, 2012
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TheraCys Intravesical Injection, Sa
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Nystatin Oral Suspension May 22, 20
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discontinued the 1 mg/mL 4 mL vials
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10 gram vial (NDC 63323-0314-61) Va
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10 mg/mL, 10 mL vial (NDC 63323-020
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Papaverine injection Reason for the
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• Mylan Institutional (formerly B
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20 mg, 100 count (NDC 00781-1695-01
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4 mL vial (NDC 00641-6008-10) 10 mL
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20 mL vials (NDC 00069-1340-02) Ond
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ecently changed old Baxter to new W
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1 mg/mL, 2 mL vial, 25 count (new N
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250 mg, 100 count unit dose (NDC 00
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Granisetron Hydrochloride Injection
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15 mg/mL, 10 mL vial (NDC 63323-048
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Ampicillin Sulbactam May 30, 2012 P
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