Health Highlights: Sept. 18, 2007
Here are some of the latest health and medical news developments, compiled by editors of HealthDay:
FDA OKs Gene Test for Warfarin Sensitivity
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."
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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.
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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.
