News Briefs
News Briefs
Blood-clotting breakthrough
Researchers have found more details for how a key blood-clotting protein works. The new information could lead to new treatments for hemophilia, strokes, and heart attacks. The protein, known as human factor VIII, is partly responsible for stopping bleeding after injuries. Hemophiliacs are often treated with infusions of that protein, but sometimes develop an immune reaction that causes factor VIII to cease working. One in 10,000 American men have hemophilia, which is carried by women but does not affect them.
Mapping the protein at the atomic level showed scientists how it interacts with other molecules to form blood clots, or, as in the case of hemophiliacs, why bleeding does not stop. It appears that a specific region of the protein is responsible for finding injury to the circulatory system and triggering the clotting response. A detailed "map" of the region may be used to help design drugs to target those areas, possibly enabling drug developers to create new variations of the protein that can outfox the patients’ immune systems.
Developing drugs that have the opposite effect for patients at risk of stroke or heart attack may also be expedited by factor VIII. Unlike current blood thinners, drugs that only target the factor VIII protein would likely have few side effects.
ZYVOX seems safe through Phase III trials
"There is currently a very real clinical need for a well-tolerated antimicrobial available in both IV and oral formulations that is effective against gram-positive bacteria that are resistant to currently licensed drugs. Such a medication in both IV and oral formulations would help ensure that patients could complete their course of therapy in the most convenient way possible," says Robert Moellering, MD, physician-in-chief and chairman, the Department of Medicine, Beth Israel Deaconess Medical Center in Boston.
Moellering, speaking at the 37th annual meeting of the Infectious Disease Society of America, also commented that "the safety profile for ZYVOX is promising."
ZYVOX has been developed in both IV and oral formulations. The oral formulation is 100% bioavailable, meaning no dose adjustment was necessary when switching from IV to oral dosing in clinical trials. Phase III clinical trial data released last September suggest that ZYVOX is effective in treating infections caused by gram-positive bacteria. The availability of an IV, tablet, and oral suspension formulation of ZYVOX would allow physicians to select the appropriate administration route for their patients.
Data collected during several large Phase III clinical trials for ZYVOX (linezolid), an investigational new antibiotic under development by Pharmacia & Upjohn, evaluated the safety of ZYVOX in the treatment of infections caused by gram- positive bacteria. The incidence of all individual drug-related adverse events in patients treated with ZYVOX and patients treated with active comparators was less than 5%.
Information presented included summaries of adverse events for 2,046 patients treated with ZYVOX and pooled results for 2,001 patients treated with active comparators. The most common side effects reported for patients treated with ZYVOX were similar in incidence and severity to the most common side effects reported for patients treated with commonly used antibiotics selected as the active comparators in the trials. The most frequent drug-related adverse events in both the group treated with ZYVOX and the group treated with comparators included mild to moderate diarrhea, nausea and headache, which each occurred in 5% or fewer patients in both groups. The comparators included ceftriaxone and cefpodoxime proxetil (cephalosporins), dicloxacillin and oxacillin (beta-lactams), clarithromycin (a macrolide), and vancomycin (a glycopeptide).
I-Flow incision pain product gets FDA approval
I-Flow Corp., manufacturer of drug infusion systems, recently announced that the Food and Drug Administration has approved marketing of the company’s Soaker Catheter, used for pain management of large surgical incisions. The catheter distributes fluid in the same manner that a soaker hose saturates a lawn, allowing the delivery of local anesthetic without the undesirable side effects of narcotic pain relievers. "I-Flow’s Soaker Catheter provides a continuous, even infusion of a non-narcotic, local anesthetic directly across long incisions for post operative pain management for such surgeries as hysterectomies, C-sections and open-heart procedures," says Donald Earhart, I-Flow’s CEO.
Liver cell infusions look promising
Two studies presented at the Radiological Society of North America annual meeting in November indicate that infusions of liver cells can keep patients alive while they are waiting for hard-to-find liver transplants. Compatible liver cells from donated livers or parts of livers that were left over after a transplant were injected into either the liver or spleen of 12 patients in Virginia. Four patients died while waiting for a transplant, but the others lived and received transplants.
The second study done at the University of Nebraska Medical Center in Omaha, NE, involved five patients. One, an infant born with a liver defect, was kept alive with an infusion for five months before receiving a successful transplant. Another, an 11-year-old girl with a genetic liver defect, is still alive two years after receiving a cell infusion and does not need a transplant. Three others in that study died.
Shortage of one type of penicillin
The shortage of one type of intravenous penicillin, which began last spring, has grown —causing the government to urge doctors to use remaining supplies carefully. However, officials of the Food and Drug Administration (FDA) say there is no cause for alarm as intravenous penicillin G is the preferred therapy for only a handful of rare infections, for which other types of penicillin or newer antibiotics can also treat successfully. Those conditions include babies born with syphilis and people whose syphilis has spread to the nervous system, and prevention of group B streptococcus from spreading in pregnant women to the fetuses they carry.
The shortage began in June, when Marsam Pharmaceuticals ceased to manufacture the drug and called its supplies due to an inspection that cited serious manufacturing deficiencies the FDA said raised questions about the drug’s safety. Pfizer Inc., the other major manufacturer of IV penicillin G, has back orders with pharmacies awaiting new supplies as soon as it can make them. The FDA is working to increase IV penicillin G supplies by helping Pfizer and other suppliers increase their production. It is also considering imported supplies.
Medicare should pay for diet advice
The Institute of Medicine, the medical arm of the National Academy of Sciences, says Medicare should pay for coverage of patients sent home with feeding tubes for intravenous feeding. Currently, Medicare treats the feeding as a device, not a service.
Three separate panels reported on whether Medicare should pay for immune-suppressing drugs for transplant patients, nutritional services, skin cancer screening, and patients taking part in clinical trials.
Congress recently extended coverage of the immune-suppressing drugs that must be taken by patients for life after an organ transplant from three years to 44 months, or just over three and a half years. The Institute’s report calls for eliminating this time limit, and says that Medicare benefits should include nutritional counseling for some patients and should pay for pricey but vital transplant drugs for a patient’s life.
"The committee recommends that nutrition therapy, upon referral by a physician, be a reimbursable benefit for Medicare beneficiaries," the report said, noting that it is very hard to change to a healthy and many elderly patients cannot make the changes without help.
Clinical point-of-care documentation system improved
Simione Central Holdings Inc. has released version 2.5 of The Smart ClipBoard clinical information system.
The Smart ClipBoard is the home health care industry’s leading Windows 95, pen-compatible, clinical information system. It provides a clinical solution designed to assist home health care providers in co-managing the cost and quality of the care they deliver through an understanding of their clinical and administrative processes. Version 2.5 offers improvements to the existing Smart ClipBoard functionality including improved replication, plan-of-care merge function, user-defined ICD-9 subsetting, revised order screens, and several new report options.
For further information, contact R. Bruce Dewey, president and CEO, at (770) 644-6700. Web site: www. simcen.com.
CINA relocates
The Canadian Intravenous Nurses Association (CINA) has relocated its office to 18 Wynford Drive, Suite 516, North York, Ontario, M3C 3S2, Canada. Telephone: (416) 445-4516. Fax: (416) 445-4513. E-mail: [email protected]. Web site: www.web.idirect.com/~csotcina.
Latex gloves used in handling food an allergen contaminant
The latest research in latex allergy points to food handlers who wear latex gloves as a potential danger.
According to a study presented by D.H. Beezhold at the 1999 annual meeting of the American College of Allergy, Asthma, and Immunology, latex glove use by food handlers can be the source of latex allergen contamination. Immunodetection showed that fingerprints of latex protein could be lifted on cheese touched with powdered latex gloves, but not with vinyl gloves.1,2 Transfer of latex protein to lettuce was also tested using an inhibition ELISA for latex protein. Again, traces were detected on lettuce handled with powdered gloves.
Since patient avoidance is currently the only method of preventing adverse reactions to latex, the results of those tests are especially significant. To avoid such unsuspected exposure, food handlers should either follow appropriate hygienic procedures or use nonlatex gloves.
References
1. Beezhold DH, Reschke J, Allen J, et al. Latex protein: A hidden food allergen. Abstract 50. Program and abstracts of the 1999 annual meeting of the American College of Allergy, Asthma, and Immunology. Chicago; November 1999.
2. Bahna S. New Findings in Food Allergy Research. Program and abstracts of the 1999 Annual Meeting of the American College of Allergy, Asthma, and Immunology. Chicago; 1999.
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