February 2012 Drug Update Information - Pharmacy Benefits ...

More documents

Recommendations

Info

Source website: http: ://www.fda.gov/default.htm The MedWatch December 2011 Safety Labeling Changes [Updatedd 1/13/12] The following drugs had modifications to the BOXED WARNINGS, CONTRAINDICATIONS and WARNINGS sections: Multaq (dronedaronee hydrochloride) tablets Dilantin-125 (phenytoin) Oral Suspension Norvir (ritonavir) Soft Gel Capsules, Oral Solution and Tablets Relenza (zanamivir) inhalation powder Tyzeka ( telbivudine) tablets and oral solution Capoten (captopril) Tablets Danocrine brand of Danazol capsules Desferal (deferoxamine mesylate) for injection Edarbi (azilsartan medoxomil) Tablets Eloxatin (oxaliplatin) for intravenous use Heparin Sodium Injection Isentress (raltegravir) scored, chewable tablets, film-coated tablet Keppra ( levetiracetam) Tablets and oral solution Onglyza (saxagliptin) tablets Ovide (malathion) 0. 5% lotion1 PegIntronn (Peginterferon alfa-2b) Injection, Powder for Solution for Subcutaneous Use Plavix (clopidogrel bisulfate) tablets Remeron (mirtazapine) tablets and RemeronSolTab (mirtazapine) Orally Disintegrating Zegerid (omeprazole e/sodium bicarbonate) powder for oral suspension and capsules Article link: http://www.fda.gov/ /Safety/MedWatch/SafetyInformation/Safety- RelatedDrugLabelingChanges/ucm284231.htm?source=govdelivery Source website: http: ://www.fda.gov Adcetris (brentuximab vedotin): Drug Safety Communication - Progressivee Multifocal Leukoencephalopathy and Pulmonary Toxicity [Posted 01/13/2012] ISSUE: FDA notified healthcare professionals that two additional cases of progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection that can result in death, have been reported with the lymphoma drug Adcetris (brentuximabb vedotin). Due to the serious nature of PML, a new Boxed Warning highlighting this risk has been added to the drug label. In addition, a new Contraindication warning was added against use of Adcetris with the cancer drug bleomycin due to increased risk of pulmonary (lung) toxicity. The signs and symptoms of PML may develop over the course of several weeks or months. They may include changes in mood or usual behavior, confusion, thinking problems, loss of memory, changes in vision, speech, or walking, and decreased strength or weakness on one side of the body. BACKGROUND: Adcetris (brentuximab vedotin) is used to treat Hodgkin lymphoma and a rare lymphoma known as systemic anaplastic large cell lymphoma. At the time of Adcetris' approval in August 2011, one case of PML was described in the Warnings and Precautions section of the label. RECOMMENDATION: Patients who develop any signss and symptoms of PML should notify their healthcare professional immediately. Healthcare professionals should hold Adcetris dosing if PML is suspected and discontinue Adcetris if a diagnosis of PML is confirmed. See the Data Summary in the Drug Safety Communicationn for additional information. 8
Studies Article Link: http://www.fda.gov/Safety/MedWatch/SafetyInformation/ SafetyAlertsforHumanMedicalProducts/ucm287710.htmm Source website: http: ://www.fda.gov/default.htm Tysabri (natalizumab): Drug Safety Communication - New Risk Factor for Progressivee Multifocal Leukoencephalopathy (PML) [Posted 01/20/2012] ISSUE: FDA notified healthcare profesisonals that testing positive for anti-JC virus (JCV) antibodies has been identified as a risk factor for progressive multifocal leukoencephalopathy (PML). PML is a rare but seriouss brain infection associated with use of Tysabri (natalizumab) for the treatment of multiple sclerosis (MS) or Crohn's disease. A patient's anti-JCV antibody status may be determined using an anti-JCV antibody detection test that has been analytically and clinically validated, and has been ordered by a healthcare professional. The Stratify JCV Antibody ELISA test2 was cleared by FDA on January 20, 2012. Testing positive for anti-JCV antibodies means that a person has been exposed to JCV in the past. BACKGROUND: Tysabri (natalizumab) is in a class of medicationss called immunomodulators. It works by stopping certain cells of the immune system from causing damage to the body. Tysabri is approved for the treatment of relapsing forms of multiple sclerosis since November 2004 and for the treatment of moderately to severely active Crohn's disease since January 2008. RECOMMENDATION: The risks and benefits of continuing treatment with Tysabri should be carefully considered in patients who are found to be anti-JCV antibody positive and have one or more of the other known risk factors for PML. Patients with all threee known risk factors have an estimated risk of PML of 11/1,000 users. Article Link: http://www.fda.gov/Safety/MedWatch/SafetyInformation/ SafetyAlertsforHumanMedicalProducts/ucm288602.htmm Source website: http: ://www.fda.gov/default.htm Drug Coatings Can Contain Problematic Chemicals December 22, 2011 Potentially harmful chemicals show up in a wide variety of drugs and supplements, especially ones with time-release coatings. A large number of common drugs and supplements contain chemicals called phthalates, which are often found in plastics, found a new study. These chemicals have been linked to a variety of hormonal andd reproductive problems in both rats and people. Article link: http://news.discovery.com/human/pill-coatings-chemicals-hormones-111222.html Source website: http: ://news.discovery.com/ Bristol-Myers Says Liver Cancer Drug Didn’t Meet Goals in Trial December 23, 2011 Bristol-Myers Squibbb Co. said its experimental brivanib drug for liver cancer didn’t improve patient survival better than a placebo. The study, one of four final-stage clinical trials evaluating brivanib in liver cancer, tested the experimental drug in patients who failed on or were intolerant to Nexavar, the liver cancer drug from Onyx Pharmaceuticals Inc. and Bayer AG, Bristol said today in a statement. New York-based Bristol will continue with the other trials, it said. Article link: http://www.bloomberg.com/news/2011-12-22/bristol-myers-says-liver-cancer- drugdidn-t-meet-goals-in-trial.html 9
Page 1 and 2: February 2012 Drug Information Upda
Page 3 and 4: GENERIC DRUG NAME GENERIC APPROVAL
Page 5 and 6: CICLOPIROX/ TOPICAL PEDIPIROX-4 New
Page 7: [Posted 01/09/2012] ISSUE: Novartis
Page 11 and 12: the use of XARELTO® (rivaroxaban),
Page 13 and 14: acteria. The Food and Drug Administ
Page 15 and 16: Statins raise risk of Type 2 diabet
Page 17 and 18: The Million Women Study, a U.K. pro
Page 19 and 20: Azithromycin 250 mg tablets, 1 card
Page 21 and 22: RECALLING FIRM/MANUFACTURE Recallin
Page 23 and 24: Recalling Firm: Pfizer Us Pharmaceu
Page 25 and 26: 250 mg, 100 count (NDC 00591-3969-0
Page 27 and 28: Sandoz states the shortage is due t
Page 29 and 30: 5 mL ampule (NDC 10019-0033-72) 20
Page 31 and 32: Article Link: http://www.ashp.org/D
Page 33 and 34: Lidocaine 2% (with epinephrine 1:10
Page 35 and 36: Source: http://www.a ashp.org Halop
Page 37 and 38: ecome unavailable for an extended t
Page 39 and 40: American Regent resumed manufacturi
Page 41 and 42: Trandate tablets, Prometheus 100 mg
Page 43 and 44: Article link: http://www.ashp.org/D
Page 45 and 46: Bedford Laboratories has multiple p
Page 47 and 48: Thiothixene capsules, Mylan 2 mg ca
Page 49 and 50: 20 mL vials (NDC 10019-0905-03) - d
Page 51 and 52: 500 mg extended release, 500 count
Page 53 and 54: 1 mg/mL, 4 mL vial (NDC 25021-0781-
Page 55 and 56: West-Ward states the shortage is du
Page 57 and 58: 150 mL bottle (NDC 63304-0954-02) C

February 2012 Drug Update Information - Pharmacy Benefits ...

Create successful ePaper yourself

Delete template?

Save as template?