A new genetic test to help doctors assess whether a patient may be especially sensitive to the blood thinning drug warfarin has been approved for use in the United States, the Food and Drug Administration said Tuesday.
Warfarin is used to prevent potentially fatal blood clots but about one-third of patients who receive it metabolize the drug differently than expected and are at an increased risk of bleeding. Warfarin is the second most common cause (behind insulin) of emergency room visits for adverse drug events.
Variants of two genes -- CYP2C9 and VKORC1 -- are known to play a role in some of the unexpected patient responses to warfarin. The new Nanosphere Verigene Warfarin Metabolism Nucleic Acid Test is able to detect some variants of both genes.
The FDA approved the test for use on a clinical laboratory test system called the Verigene System. Both products are made by Nanosphere Inc. of Northbrook, Ill.
The approval "offers physicians the first FDA cleared genetic test for warfarin sensitivity, which is another step in our commitment to personalized medicine," Dr. Daniel Schultz, director of the FDA's Center for Devices and Radiological Health, said in a prepared statement. "With this test, physicians may be able to use genetic information along with other clinical information to treat their patients."
Revised Warnings Section on Haloperidol Label
Doctors are being advised that there's a revised warnings section of the prescribing information for the antipsychotic drug haloperidol, drug maker Johnson and Johnson and the U.S. Food and Drug Administration said Monday.
The revision includes a new subsection alerting doctors about cases of sudden death, or heart troubles known as QT prolongation and Torsades de Pointes (TdP) in patients treated with haloperidol, especially when the drug is given intravenously or at higher-than-recommended doses.
Injectable haloperidol is only approved by the FDA for intramuscular injection. However, the agency said there is considerable evidence that intravenous administration of haloperidol is a relatively common off-label clinical practice.
There have been at least 28 case reports of QT prolongation and TdP, including some deaths, after haloperidol has been given intravenously. Doctors should consider this new information when making treatment decisions for patients, the FDA said.
Smoking May Boost Women's Acne Risk
Female smokers may be much more likely to develop non-inflammatory acne (NIA) than women who don't smoke, says an Italian study in the British Journal of Dermatology.
Researchers looked at more than 1,000 women and found that 40 percent of those who smoked had NIA, compared with 10 percent of nonsmokers. Blocked pores, large white heads and small cysts are characteristic of NIA, BBC News reported.
The team at the San Gallicano Dermatological Institute in Rome said they conducted the study in women because the condition seems to be more prevalent in women than in men. Compared to nonsmokers, smokers in the study had half the levels of skin secretions of vitamin E and had other skin-related variations. The study also found that smokers who had acne in their teens were four times more likely to suffer NIA than nonsmokers who experienced teen acne.
The findings add to previous research that links smoking with acne, Colin Holden, president of the British Association of Dermatologists, told BBC News.
E. coli Prompts Dole Salad Mix Recall
Packages of Dole salad mix have been recalled in at least nine U.S. states and in a number of Canadian provinces after a package in Canada tested positive for E. coli bacteria, the Associated Press reported.
The recall covers all packages of Dole's Hearts Delight salad mix with a "best if used by" date of Sept. 19, 2007, and a production code of "A24924A" or "A24924B." They were sold in Ontario, Quebec and the Maritime provinces in Canada, and in Illinois, Indiana, Maine, Michigan, Mississippi, New York, Ohio, Pennsylvania and Tennessee starting around Sept. 8, said Dole spokesman Marty Ordman.
He said that 755 cases containing 4,530 bags of the salad mix were distributed in the United States and 88 cases with 528 bags were distributed in Canada, the AP reported. The romaine, green leaf and butter lettuce hearts used in the salad mix were grown in California, Colorado and Ohio and processed at Dole's plant in Springfield, Ohio.
This recall comes one year after an outbreak of E. coli linked to bagged baby spinach sold under the Dole brand killed three people and sickened hundreds in the United States.
U.S. Per Capita Health Spending Highest in Northeast
New England and the rest of the northeastern United States had the highest annual health-care spending per person in the country in 2004, a new study says.
The report said annual health-care spending per person was $6,409 in New England and $6,151 in the rest of the Northeast, compared to a national average of $5,283 in 2004, the year for which the most recent figures are available, the Associated Press said.
Those costs covered spending on all individual health care from all sources, including personal expenses, insurance, Medicare and Medicaid. Leading per capita spending in the Northeast were: the District of Columbia ($8,295); Massachusetts ($6,683); Maine ($6,540); and New York state ($6,535).
Outside of the Northeast, Alaska ($6,450) was the only state where spending was above $6,000. In the Southwest and Rocky Mountain regions, per capita health-care spending was below the national average. Utah had the lowest annual health-care spending per person ($3,972), the AP reported.
The study, by the Centers for Medicare and Medicaid Services, was published Tuesday in the journal Health Affairs.
Mutant Gene Hinders Brain Cells in People With Fragile X Syndrome
A mutant gene that causes fragile X syndrome -- the most common cause of inherited mental retardation -- hinders communication between brain cells, say Emory University researchers, who were able to use drugs to reverse the mutation in rats' brain cells.
They say their findings, published in the journal Proceedings of the National Academy of Sciences, may help in efforts to develop a treatment for fragile X syndrome, BBC News reported.
In 1991, Emory researchers first identified a mutant form of the FMR1 gene as the cause of fragile X syndrome. People with this mutation can't produce an important protein called FMRP.
In this new study, the researchers found that the lack of FMRP results in a chemical imbalance that leads to a breakdown in communications between brain cells. This results in the mental deficits typically seen in people with fragile X syndrome, BBC News reported.