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Drug Information Center – Forum
Volume 1, Issue 3

Thursday, October 19, 2000


  • Joe Silivongxay
  • Osita Osaji
  • Cynthia Truong
  • Loan Mai
  • Sara Gibbons
  • Quoc Nyugen


New Drug Approvals

  • Kaletra Oral Solutionâ 9-15-00
    • Lopinavir oral solution, (80mg lopinavir/20 mg ritonavir)
    • Approved for the treatment of HIV-1 infections in adults and pediatric patients age six months and older.
    • Manufactured by Abbott Laboratories
    • NDA 21-251
  • Kaletra Capsulesâ 9-18-00
    • Lopinavir capsules, (133.3 mg lopinavir/33.3 ritonavir)
    • Approved for the treatment of HIV-1 infections in adults and pediatric patients age six months and older.
    • Manufactured by AstraZeneca Pharmaceuticals
    • NDA 21-226
  • QVar Inhalation Aerosolâ 9-15-00
    • Beclomethasone dipropionate HFA 40 mcg and 80 mcg
    • Approved for prophylactic treatment of asthma. QVar is also indicated for asthma patients who require systemic corticosteroid administration, where adding Qvar may reduce or eliminate the need for the systemic corticosteroids.
    • Manufactured by 3M Pharmaceuticals
    • NDA 20911
  • Trisenox Injectionâ 9-25-00
    • Arsenic trioxide injection, 10 mg/ml & (1 mg/ml) ampule
    • Approved for the treatment of acute promyelocytic leukemia (APL) who are refractory to, or have relapsed from, tetinoid and anthracycline chemotherapy.
    • Manufactured by Cell Therapeutics Inc.
    • NDA 21-248
  • Ovidrelâ 9-18-00
    • Ovidrel (choriogonadotropin alfa) powder for injection
    • Approved for the induction of final follicular maturation and early luteinization in infertile women who have undergone pituitary desensitization and who have been appropriately pretreated with follicle stimulation hormones as part of an assisted reproductive technology program such as in vitro fertilization and embryo transfer. Ovidrel is also indicated for the induction of ovulation and pregnancy in anovulalory infertile patients in whom the cause of infertility is functional and not due to primary ovarian failure.
    • Manufactured by Serono
    • NDA 21-149

New Drug Indications

  • Arimidexâ 9-21-00
    • Anastrozole Tablets (strength approved was not indicated)
    • Approved for the first-line treatment of postmenopausal women with hormone receptor positive or hormone receptor unknown locally advanced or metastatic breast cancer
    • Manufactured by AstraZeneca Pharmaceuticals
    • NDA 20-541/S-006
  • Accolate Tablets â 9-24-00
    • Zafirlukast 10 mg tablets
    • Approved for treatment of prophylaxis and chronic treatment of asthma in pediatric patients 7-11 years of age
    • Manufactured by AstraZeneca Pharmaceuticals
    • NDA 20-547/S-007
  • Astelinâ 9-22-00
    • Azelastine HCl nasal spray
    • Approved for the treatment of seasonal allergic rhinitis symptoms such as rhinorrhea, sneezing, and nasal pruritus in adults and children 5 years of age and older. Astelin was formerly approved for adults and children 12 years of age and older.
    • Manufactured by Wallace Laboratories

Drug Recalls: SEPTEMBER 2000

  • 10/10 Etodolac 300 mg Capsules Lot Number 9991052
  • 9/1 Homatropine hydrobromide Ophthamic Solution 5% 1m
    • Reason: Potency not within USP specification (stability)
    • Manufacturer: OMJ- Puerto Rico
  • 9/6 Haemophilus b Conjugate Vaccine (HibTITER)
    • Reason: Products were airfreighted without a documented freeze indicator.
    • Manufacturer: Wyeth-Ayerst Pharmaceutical
    • 9/6 Anthrax Vaccine Adsorbed
    • Reason: Wrong expiration date
    • Manufacturer: Bioport Corp
    • 9/13 Diphtheria & Tetanus Toxoids Adsorbed
      • Reason: Cannot be assured the product is sterile
      • Manufacturer: Bioport Corp
        • 9/14 Collagenase, Santyl Oilment 30gram tube, 250 ABC units per gram
          • Reason: The bulk ointment failed sterility testing
          • Manufacturer: Avanced Biofactures Corporation
            • 9/14 Sterile Talc Powder, 4g in 100ml amber vial
              • Reason: Product may be non-sterile, misbranded and considered by FDA to be an unapproved New Drug
              • Manufacturer: Bryan Corporation
                • 9/20 Digoxin Injection USP 0.25mg per 1ml
                  • Reason: Product may be chipped or cracked
                  • Manufacturer: Wyeth-Ayerst
  • 9/20 Leucovorin Calcum Injection
    • Reason: Particulates in solution
    • Manufacturer: Gensia Sicor
      • 9/27 Lavoptik Eye/Face/Body/Wash
        • Zee Protector II Refill Eye Wash Solution in 5qt. Size
        • Zee Normal Saline Solution in 16oz.
        • Rapid Clear Eye
        • Reason: Potential non-sterility and could represent serious health hazard
        • Manufacturer: H.L. Bouton


Primary Literature Reviews

Use of Sympathomimetic Drugs Leads to Increased Risk of Hospitalization for Arrhythmias in Patients With Congestive Heart Failure

Marcel L. Bouvy, Eibert R. Heerdink, Marie L. DeBruin, Ron M.C. Herings, et al.

Archives of Internal Medicine Sept. 11, 2000;160: 2477-2480.

Sympathomimetic agents have a direct positive chronotropic effect on heart rate, which can lead to arrhythmias in patients with congestive heart failure. This can lead to extended hospital stays for some patients. A study of 1208 patients with CHF was conducted. Of these, 149 patients were readmitted to the hospital for arrhythmias. A control group of 149 patients who had no hospital readmission for any cardiac cause was used for comparison in a case-control design. 22.1% of the 149 arrhythmia patients versus 11.4% of the control patients were treated with a sympathomimetic agent. The study concluded that the data supports an increased risk of hospitalization for arrhythmias in CHF patients who are treated with sympathomimetic drugs. The researchers recommend close surveillance of patients with CHF who are using these drugs.

Type of Alcohol Consumed and Mortality from All Causes, Coronary Heart Disease and Cancer

Morten Gronbaek, Ulrik Becker, Ditte Johansen, Adam Gottschau, et al.

Annals of Internal Medicine Sept 19, 2000;133(6): 411-419.

This study, performed in Denmark, examined the effects of different types of alcoholic beverages on mortality. A population of 13,064 men and 11,459 women was studied using a pooled cohort design. Intake of beer, wine, and spirits, smoking status, educational level, physical activity, and body mass index were assessed at baseline. The outcome measures were the number of deaths and the time to death from all causes, coronary heart disease, and cancer. Light drinkers had a reduced risk of death compared with nondrinkers. The researchers concluded that wine intake may have a beneficial effect on mortality.

Conversion of Patients from Simvastatin to Lovastatin in an Outpatient Pharmacy Clinic

Randolph V. Fugit, Nina D. Resch

Am J Health-Syst Pharm Sept 15, 2000; 57:1703-1708.

Lovastatin and simvastatin were the HMG-CoA reductase inhibitors approved for the Department of Vetarans Affairs national formulary in 1996. Other studies have supported the conclusion that simvastatin has, on a milligram per milligram basis, two times the LDL-C lowering potential of lovastatin. The Albuquerque Veterans Affairs Medical Center approved the conversion of patients receiving low dose simvastatin (5 and 10mg/ day) to lovastatin (10 and 20mg / day) in an attempt to reduce costs associated with HMG-CoA reductase inhibitor therapy. A descriptive study was performed at the Albuquerque VAMC in a pharmacist managed outpatient hyperlipidemia clinic. The analysis of 96 patients with hyperlipidemia revealed that most patients could easily be converted to a more cost effective regimen with similar lowering potential.

Cyclosporine-Drug Interactions and the Influence of Patient Age

Jennifer Lill, Larry A. Bauer, John R. Horn, and Philip D. Hansten

Am J Health-Syst Pharm Sept 1, 2000; 57: 1579-84.

This study examines the impact of age on cyclosporine-drug interactions in adult transplant patients. A retrospective medical record review was done on 100 transplant patients receiving cyclosporine. Twelve drugs with previously unconfirmed interactions with cyclosporine were identified as interacting. Patients 60-75 years of age had cyclosporine-drug interactions similar to those in younger patients.

Minimum Effective Intensity of Oral Anticoagulant Therapy in PrimaryPrevention of Coronary Heart Disease

Peter MacCallum, Patrick Brennan, Thomas Meade

Arch Intern Med Sep 11, 2000; 160(16): 2462-8

This study examines whether low-dose warfarin is effective in the primary prevention of coronary heart disease. Data from the Thrombosis Prevention Trial, comparing low-intensity warfarin with low-dose aspirin, were used to determine the minimum effective intensity of warfarin therapy needed to prevent coronary heart disease. Subjects were 2545 men at risk of suffering coronary events who were receiving warfarin with or without aspirin. The study concludes that warfarin alone is effective in the primary prevention of coronary heart disease when the dose is adjusted to maintain an INR of 1.4 or more.

This Issue's Review Article

Raloxifene Hydrochloride

Kelly R. Snyder, Nicole Sparano, Jennifer M. Malinowski

Am J Health-Syst Pharm September 15, 2000;57(1):1669-1678.

This article reviews the indications, pharmacology, pharmacokinetics, clinical efficacy, adverse effects, and therapeutic role of raloxifene hydrochloride. This drug can be used as an alternative to traditional hormone replacement therapy for the prevention and treatment of osteoporosis in selected postmenopausal women. More study is needed to verify possible benefits related to heart disease and breast cancer.

Contact Information:
H. Glenn Anderson, Jr Pharm.D.

Ann L. McIlvain Pharm.D
Texas Tech Drug Information Center