New hepatotoxicity warning added to nevirapine (Viramune)
Boehringer Ingelheim Pharmaceuticals is informing health care professionals about new labeling information being added to the boxed warning for nevirapine (Viramune), a non-nucleoside reverse transcriptase inhibitor indicated for the treatment of HIV-1 infection in combination with other antiretroviral agents. Specifically, the company gives these warnings:
- Women with CD4+ counts greater than 250 cells/mm3, including pregnant women receiving chronic treatment for HIV infection, are at considerably higher risk (twelvefold) of hepatotoxicity. Some of these events have been fatal. This subset of patients was identified by analyses of CD4 count at the time of initiation of nevirapine therapy.
- The greatest risk of severe and potentially fatal hepatic events (often associated with rash) occurs in the first six weeks of nevirapine treatment. However, the risk continues after this time and patients should be monitored closely for the first 18 weeks of treatment with nevirapine.
- In some cases, hepatic injury progresses despite discontinuation of treatment.
This new information is the result of recent post-marketing surveillance data and further analysis of the nevirapine clinical trial database.
The company reports that some experts recommend clinical and laboratory monitoring more often than once a month. They would include monitoring of liver function tests at baseline, at the time of dose escalation, and two weeks after dose escalation. All patients developing a rash, at any time during nevirapine treatment, but particularly during the first 18 weeks, should have liver function tests performed at that time. After the initial 18-week period, frequent clinical and laboratory monitoring should continue throughout nevirapine treatment.
FDA announces improved drug approval results in 2003
The U.S. Food and Drug Administration announced improved results over last year on overall drugs and biologics approvals for calendar year 2003, and decreases in the time it took the agency to review and approve most applications.
The agency’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) approved 466 new and generic drugs and biological products.
In 2003 CDER approved 72 new drug applications (NDAs), compared with 78 in 2002 and 66 in 2001. Of these NDA approvals, 21 were New Molecular Entities (NMEs), with active ingredients never before marketed in the United States. This is up from the calendar year 2002 total of 17. Priority approvals — approvals for priority products of special medical importance — increased to 14 priority NDAs and nine priority NMEs in 2003, compared to 11 and seven, respectively, in 2002.
Median total approval time for CDER’s priority NDAs was 7.7 months, compared with 19.1 months for 2002. FDA has attributed the 2002 figure to the effect of a few applications with unusually long regulatory histories. The median total approval time for standard NDAs was 15.4 months, also in line with the previous year (15.3 months).
For more details about 2003 CDER and CBER approvals, see www.fda.gov/bbs/topics/NEWS/2004/NEW01005.html.
Savings noted with increased use of beta-blockers
Using a decision model, researchers estimate that Medicare costs would decrease if the use of beta-blocker drugs were more widespread, according to a new study sponsored by the Agency for Healthcare Research and Quality (AHRQ). The study, "Economic Effects of Beta-Blocker Therapy in Patients with Heart Failure," is published in the January issue of American Journal of Medicine.
Researchers from the AHRQ-sponsored Duke Center for Education and Research on Therapeutics in Durham, NC, estimated that treatment for heart failure without beta-blocker drugs would cost Medicare an estimated $39,739 per-patient over a five-year period; however, treatment with beta-blockers would cost an estimated $33,675 — a per-patient savings of $6,064. In contrast, beta-blocker therapy would increase expenses to Medicare patients by an estimated $2,113 over five years.
Although at the time of the study, Medicare did not cover prescription drugs, researchers estimated that program savings would remain positive even if Medicare reimbursed patients for the cost of beta-blockers.
Estimates in the study were calculated using a Markov decision model. Calculations were based on clinical trial data on rates of hospitalization/ death and effectiveness of beta-blockers, Duke University Medical Center estimates of hospital costs and reimbursement, and physician fees from the Medicare fee schedule.
First TB vaccine trial in 60 years to begin
A new vaccine, made with several proteins from the bacterium that causes tuberculosis (TB), will soon enter the first phase of human safety testing. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has supported research on the candidate vaccine from its earliest stages.
Corixa and GlaxoSmithKline Biologicals will conduct the trial in the United States. The vaccine combines two TB proteins known to stimulate strong immune responses in humans. The proteins initially were identified by screening blood taken from volunteers who never became ill with TB despite long-term infection with M. tuberculosis bacteria. Using recombinant DNA technology, the TB proteins were fused and then combined with adjuvants. NIAID grants awarded in the late 1990s supported research that uncovered the most effective adjuvant-protein combination.
Study: Consumers don’t understand drug formularies
Many Americans do not understand one of managed care’s most basic and universal tools to control prescription drug costs, according to a recent study.
The study, published in the January issue of Managed Care Interface, explained that the general public does not know the answers to most prescription drug questions such as "Why does one medication have a higher copayment at the pharmacy than another?" "Why are some drugs so much more expensive than others?" and "What is a formulary?" The authors believe that this lack of knowledge fuels health plan member dissatisfaction and frustration.
In the article, "Consumer Knowledge and Perceptions of Formularies" Sangit Sansgiry, PhD, and his team from the University of Houston College of Pharmacy noted that only 25% of 714 Houston health plan members responding to a survey had a copy of their drug formulary.
Once formularies were explained to members, the most prevalent attitude toward them was negative: 73% of the consumers believed that formularies compromised the quality of their medications; and 72% believed that the use of formularies encouraged the use of less effective medications. In addition, only 30% of the survey respondents were aware of the kind of information that was in their formulary.
One interesting finding in the study is that consumers generally were happy with their health plans, yet had negative attitudes toward formularies. The implementation of effective and consistent educational initiatives may be the answer to informing consumers about formularies and their role in the health care continuum.
Vantin antibiotic batch recalled
Graham Development, a distributor in Oneonta, NY, has begun a voluntary recall of one lot of Vantin 200 mg tablets (Lot #K08210301), a prescription antibiotic. There is a possibility that product dispensed from this lot may contain the heart medication digoxin (Lanoxin). Consumers who inadvertently take digoxin while assuming it is Vantin are at risk of serious health consequences such as ventricular arrhythmia and death. Affected drug distributors and pharmacies are being notified.
The bottles in question may identify Graham Development or Pharmacia & Upjohn Co. as the source of the product and were dispensed after Dec. 12, 2003. Vantin tablets and digoxin tablets are different in color, size, shape, and markings. Vantin tablets are football shaped, orange/red, film-coated, and embossed with "U" and "3618," and Lanoxin tablets are round, white tablets, scored, and embossed "LANOXIN" and "X3A."
The approximately 420 bottles in distribution were shipped to pharmacies and distributors in the northeastern United States, Kentucky, Minnesota, Missouri, and South Dakota.