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Drug Information Center – Forum
Volume 1, Issue 2

Thursday, October 5, 2000


  • Cindy Johnson
  • Heather Johnson
  • Susan Nguyen
  • Nguyet Dang
  • Jimmy Tran
  • Ana Mata
  • Chris Ellison


New Drug Approvals

  • Cetrotide: 08-11-00
    • Cetrorelix-Injectable
    • Approved for prevention of premature LH surges in women undergoing controlled ovarian stimulation
    • Manufactured by Asta Medica Inc.

New Drug Indications

  • Vivelle: 08-11-00
    • Indications: Used to prevent postmenopausal osteoporosis
    • Manufactured by Novogyne
  • Amphotericin B (AmBisome): 08-01-00
    • Indications: treatment of cryptococcal meningitis in HIV-infected patients
    • Manufactured by Fujisawa Healthcare/Gilead Sciences'
  • Ciprofloxacin: 09-01-00
    • Indications : For post exposure inhalation of anthrax, which is most likely to occur during a bioterrorist attack.
    • Manufactured by Bayer

Drug Recalls


  • Orasone™
    • Lot Number 89335
    • Solvay Pharmaceuticals Inc.
    • Dissoulution Failure – only had 18 months stability
  • New Life Colostrum Cream
    • Lot Number A2106990
    • Vege-Kurl
    • Microbial Contamination
  • Marquee Brand Menthol Throat Spray
    • Lot Number 9JV0178
    • Perrigo Co
    • Missing Tamper Resistant Protection

Primary Literature Reviews

Update on preventing vertical transmission of HIV type 1

Fonda Chen, Alice K. Pau, and Stephen C. Piscitelli

Am J Health-Syst Pharm Sept 1, 2000; 57:1616-1623

There are numerous clinical trials underway studying the prevention of vertical transmission of HIV-1, which occurs in utero, intrapartum, and postpartum. The PACTG 076 trial, a landmark study for prevention of perinatal transmission using zidovudine and nevirapine, and HAART (highly active antiretroviral therapy) have dramatically changed the outcomes in percentage of transmissions from mother to baby. However, more affordable and less complex regimens are still in need, especially for the developing nations most afflicted by perinatal HIV-1. This article lists several selected studies of antiretroviral therapy for the prevention of this virus transmission in both the United States and other countries as study sites. The dosages and therapies are divided up between antepartum, intrapartum, and postpartum for both mother and newborn. The rate of vertical transmission has fallen from over 20% to 3-10% since these studies began. Much progress has been made yet the efforts continue for the search for relatively simple, inexpensive, and effective regimens.

Duration of Symptoms and Plasma Cytokine Levels in Patients with the Common Treated with Zinc Acetate

Ananda S. Prasad, MD, PhD; James T. Fitzgerald, PhD; Bin Bao, MD, PhD; Frances W.J. Beck, PhD; and Pranatharthi H. Chandrasekar, MD

Annals of Internal Medicine August 15, 2000; Vol.133:245-252.

This study was done at the Detroit Medical Center to test the efficacy of zinc acetate lozenges in reducing the duration of symptoms of the common cold. The trial was randomized, double blind, and placebo-controlled. Forty-eight subjects were given 12.8mg of zinc acetate or placebo every two to three hours for as long as they had cold symptoms. The results were compiled from the patients' daily documentation of the severity of their cold symptoms. Compared to the placebo group, the treatment group had reduced severity and a shorter duration of cold symptoms. However, the differences between proinflammatory cytokine levels in zinc versus placebo subjects were not significant.

Determination of Up-to-Date Vaccination Status for Preschool-Aged Children: How Accurate Is Manual Assessment Conducted by Paraprofessional Staff?

Abigail Shefer, MD; Elisa Webb, MSN; and Terri Wilmoth, RN, MPH

Pediatrics September 2000; Vol. 106(3): 493-496.

Over the years, the increased use of vaccination has led to a decrease in vaccine-preventable diseases in the United States. However, more than 1 million preschool-aged children still remain underimmunized and at risk for disease. One of the reasons for this is that health care providers sometimes do not accurately identify which children are in need of vaccination. Previous studies have found a low accuracy rate when nurses manually determine a child's immunization status from the child's personal vaccination record. This study's objective was to determine the accuracy of immunization status assessment conducted manually by paraprofessional staff in the Women, Infants, and Children (WIC) program, as compared to a computerized assessment based on actual immunization data contained in the WIC database. The subjects were children 32 months old or younger, seen during a 1 year time period at one of 12 WIC sites in San Diego, California. This study found that the children's vaccination status was assessed correctly 80% of the time. The authors concluded that manual immunization assessment is specific but only moderately sensitive in identifying an underimmunized child, thus many underimmunized children are missed. The authors recommend that computer-assisted assessment be used to reduce error.

Failure To Develop HIV Infection After Receipt of HIV-Contaminated Blood and Postexposure Prophylaxis

Terese L. Katzenstein, MD, PhD; Ebbe Dickmeiss, MD, DrMedSci; Hassan

Aladdin, MSc; et al.

Annals of Internal Medicine July 4 2000; Vol.133:31-34.

The screening of donated blood for the HIV-antibody has greatly reduced the risk for HIV transmission from blood transfusions. However, due to an estimated three week window period between HIV infection and development of HIV antibodies, some HIV-infected blood is not detected in this screening process. In this case report, a 13 year old underwent transfusion with HIV RNA-positive blood. Two days after the transfusion, the blood was discovered to be infected with HIV, and the patient was started on postexposure prophylactic antiretroviral therapy which was continued for 9 months. The patient was repeatedly tested for HIV RNA, HIV DNA, HIV antibody, and HIV p24 antigen, and all tests were found to be negative.

Association Between Administration of Hepatitis B Vaccine at Birth and Completion of the Hepatitis B and 4:3:1:3 Vaccine Series

Hussain R. Yusuf, MBBS, MPH; Danni Daniels, MS; Phil Smith, PhD; Victor Coronado, MD, MPH; Lance Rodewald, MD

The Journal of the American Medical Association August 23/30, 2000; Vol. 284, No. 8: 978-983.

This study was done to assess whether there is a greater likelihood of a child completing the entire 3 dose hepatitis B vaccination series as well as the 4:3:1:3 (diphtheria, tetanus, pertussis, polio, measles, and Haemophilus influenzae type b) vaccination series if the child receives the first dose of hepatitis B vaccine within 7 days of birth. Data from the 1998 National Immunization Survey, which consisted of a telephone survey of parents in the United States and a mail survey of their vaccination providers, was used. The study found that 89.6% of children aged 19 to 35 months in 1998 received 3 or more doses of Hepatitis B vaccine and 79.9% completed the 4:3:1:3 vaccine series. Children who received the first hepatitis B vaccine dose within 7 days of birth were much more likely to complete both vaccine series than children who did not.

Contact Information:
H. Glenn Anderson, Jr Pharm.D.
Ann L. McIlvain Pharm.D
Texas Tech University HSC
Drug Information Center