News Briefs
CDC announces strategy for 2005-06 flu season
The Centers for Disease Control (CDC) in Atlanta has announced that the supply of inactivated influenza vaccine projected for the 2005-06 season should be adequate to meet the historical demand from persons in the priority groups established by Advisory Committee on Immunization Practices (ACIP) during the 2004-05 season. The announcement was published in the April 1 issue of Morbidity and Mortality Weekly Report.
Sanofi Pasteur and MedImmune produced approximately 61 million doses of influenza vaccine for distribution in the United States during 2004-05; the companies predict producing approximately the same amount or slightly more doses for the upcoming season. The production of Chiron Corp. is unknown. On March 2, the British Medicines and Healthcare products Regulatory Agency lifted its Oct. 5, 2004, suspension of Chiron’s license to manufacture influenza vaccine. The FDA must also give its approval before this vaccine can be distributed in the United States. In addition, the CDC says, other manufacturers are discussing with FDA the possible licensure of influenza vaccine for the 2005-06 influenza season and beyond.
The CDC is encouraging implementation of a two-tiered pre-booking strategy by manufacturers, distributors, and customers of inactivated vaccine. This strategy requires customers of inactivated vaccine to provide two requests for supplies, using 1) the number of doses needed based on anticipated demand among persons in the priority groups, in case vaccine supply is limited; and 2) the number of doses needed based on priority group use, plus other groups, if supplies prove sufficient to meet demand from other people seeking vaccination.
Here are the following priority groups to be used as a guide for prebooking orders for inactivated influenza vaccine:
- People ages > 65 years.
- People ages 2-64 years with underlying chronic medical conditions.
- All women who will be pregnant during the influenza season.
- All children ages 6-23 months.
- Health care workers involved in direct patient care.
- Out-of-home caregivers and household contacts of children ages < 6 months.
- Residents of nursing homes and long-term-care facilities.
- Children ages 6 months to 18 years on chronic aspirin therapy.
- For more information, see www.cdc.gov/mmwr/preview/mmwrhtml/mm5412a4.htm.
One-quarter of warfarin response variation linked to single gene
Researchers at the University of Washington in Seattle and Washington University in St. Louis wanted a clearer picture of why patients respond so differently to the anticoagulant drug warfarin (Coumadin).
Studies have shown that variations in a gene encoding the CYP2C9 enzyme that metabolizes warfarin explain about 10% of the difference in people’s responses to the drug. These researchers instead focused on another gene: vitamin K epoxide reductase (VKORC1). The researchers analyzed the VKORC1 gene’s DNA sequence in 186 patients on a stabilized dose of warfarin. They searched for common DNA variations responsible for changing the gene’s activity and the amount of protein it produced.
By matching the genetic variations to actual warfarin doses, the scientists discovered that people with a particular variation of the VKORC1 gene generally took similar doses of warfarin, according to the National Institutes of Health (NIH). The study was part of NIH’s Pharmacogenetics Research Network and was supported by the NIH components National Institute of General Medical Sciences; the National Heart, Lung, and Blood Institute; and the National Institute of Environmental Health Sciences.
The researchers found that about 25% of the overall variance in warfarin dose can be attributed to VKORC1. "This is possibly the single biggest contributor to variability in people’s responses to the drug and could be a central factor in setting the initial dose," said Allan E. Rettie, PhD, professor of medicinal chemistry at the University of Washington, in a statement.
The researchers also discovered that certain population groups tended to have a higher prevalence of a particular VKORC1 variation. While Asian Americans generally had the low-dose variation, African Americans had the high-dose version. European Americans fell in the middle.
The researchers agreed that more studies should be done before screening for the VKORC1 gene for better warfarin dosing. "What we’ve done is the basic science," said Rettie. "This complete genetic analysis of VKORC1 provides the mechanistic framework and impetus for prospective studies in a clinical setting."
The results of the study were published in the June 2 issue of the New England Journal of Medicine.
Breast cancer trial halts chemo regimen after patients’ deaths
A breast cancer chemotherapy regimen that involved simultaneous administration of docetaxel and doxorubicin suppressed white blood cell activity in 40% of patients and led to two treatment-related deaths, said a report on the European RAPP-01 clinical trial published in the May 18 Journal of the American Medical Association.
The rates of neutropenia in the docetaxel arm were high because, unlike similar studies conducted in the United States, the French trial did not employ prophylaxis for neutropenia, noted investigators in the National Cancer Institute’s Cancer Therapy Evaluation Program. Patients received granulocyte colony-stimulating factor only after their white cell count had already dropped.
While the docetaxel regimen caused less nausea and vomiting than the standard therapy, it was responsible for 72 of the 87 severe adverse events (82.8%) reported to the French Medicines Agency. Most of these events (87.5%) were related to febrile neutropenia.
Able Laboratories recalls all drugs, ceases production
The FDA has notified consumers and health care professionals of a nationwide recall of all manufactured drugs (mostly generic prescription drugs, including drugs containing acetaminophen) from Able Laboratories of Cranbury, NJ, because of serious concerns that they were not produced according to quality assurance standards. Able Laboratories has ceased all current production.
The FDA recommends that people who have been taking drugs produced by this firm speak with their health care provider or pharmacist to obtain a replacement drug product. Consumers should continue taking the medication until they have spoken with their health care provider. The FDA has provided a list with the names of the recalled drugs and their imprint codes, marks (usually letters and numbers) found on the surfaces of drugs.
For more information, see www.fda.gov/medwatch/SAFETY/2005/safety05.htm#Able.
Scios revises nesiritide, mitoxantrone labels
Scios has revised the label of nesiritide (Natrecor) after published reports questioned whether the drug may have adverse effects on survival and kidney function compared to control agents (generally nitroglycerin and diuretics).
The revised label language is based on the analyses of survival data from seven controlled studies, including three studies used in the meta-analysis that recently appeared in The Journal of the American Medical Association (JAMA). The label now includes 30-day mortality data in addition to the 180-day data that previously appeared in the label.
The analyses show a nominal increase in mortality, but the increases are not statistically significant, and therefore remain of uncertain clinical significance, Scios says.
For more information, see www.fda.gov/medwatch/SAFETY/2005/safety05.htm#natrecor.
Serono and the FDA also have notified health care professionals of revisions to the boxed warning, warnings, and dosage and administration sections of the prescribing information of mitoxantrone for injection concentrate (Novantrone).
Mitoxantrone is indicated for reducing neurologic disability and/or the frequency of clinical relapses in patients with secondary (chronic) progressive, progressive relapsing, or worsening relapsing-remitting multiple sclerosis (MS).
Reports received through post-marketing surveillance have shown that diminished cardiac function may occur early on in the treatment with mitoxantrone.
Cardiotoxicity can occur at any time during mitoxantrone therapy, and the risk increases with cumulative doses. Congestive heart failure, potentially fatal, may occur either during therapy with mitoxantrone or months to years after termination of therapy. Therefore, the product labeling for mitoxantrone was updated in March to state that cardiac monitoring of MS patients should be performed at baseline and prior to administration of every dose of mitoxantrone.
The revised label also provides supplemental information regarding secondary acute myelogenous leukemia (AML) reported in MS patients treated with mitoxantrone. Cases of the secondary AML have been reported in peer-reviewed literature, through the collection of spontaneous reports, and in a prospective observational study.
Because the number of MS patients exposed to mitoxantrone in post-marketing is unknown and spontaneous reporting of adverse events can be subject to underreporting, it is not possible to determine incidence — or relative risk to an MS patient — of developing secondary AML.
For more information, see www.fda.gov/medwatch/SAFETY/2005/Novantrone_dearhcp.pdf.
The Centers for Disease Control (CDC) in Atlanta has announced that the supply of inactivated influenza vaccine projected for the 2005-06 season should be adequate to meet the historical demand from persons in the priority groups established by Advisory Committee on Immunization Practices (ACIP) during the 2004-05 season.Subscribe Now for Access
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