The Wall Street Journal (12/13, D4, Dooren) reports that the FDA "strengthened warnings on certain drugs used to treat epilepsy, bipolar disorder, and nerve pain, discussing the possibility of rare skin disorders, and recommending that patients with Asian ancestry undergo genetic testing before using the drugs." The drugs are "sold under the brand names Carbatrol (carbamazepine) by Shire PLC, Tegretol (carbamazepine) by Novartis AG, and Equetro (carbamazepine) by Validus Pharmaceuticals Inc., a privately held firm." According to the FDA, "the prescribing information for the drugs already carries a warning about the possibility of rare but severe -- and sometimes life-threatening -- skin reactions for all patients starting carbamazepine therapy." Such "reactions include toxic epidermal necrolysis and Stevens-Johnson syndrome, characterized by multiple skin lesions, blisters, fever, and itching, the agency said."

        According to the UPI (12/13), the "risk of such skin reactions is about one to six per 10,000 patients in countries with mainly white populations." But," the risk is estimated to be about 10 times higher in some Asian nations."

        MedPage Today (12/13, Mattera) reports that the gene, called "HLA-B*1502 allele, is found almost exclusively in patients of Asian ancestry, and is particularly prevalent in China, Thailand, Malaysia, Indonesia, the Philippines, and Taiwan, and to a lesser degree, in South Asia, including India."

        In the Wall Street Journal's (12/12) Health Blog, Jacob Goldstein wrote that the "world took another baby step toward personalized medicine today, as the FDA said people of Asian descent should be screened for a particular genetic variation before they take carbamazepine." Therefore, "the agency recommends that Asian patients be tested for the genetic variant before being given the drug." Should "the patient carr[y] the gene, a doctor should carefully weigh the heightened risk of reaction." Still, Robert Nussbaum, M.D., chief of medical genetics at the University of California, San Francisco, "downplayed the significance of ethnicity or geographic origins," because everyone has certain risk factors. HealthDay (12/13) also covers the story in its Health Highlights section.

        Genetic tests may not provide solutions for consumers. The Wall Street Journal (12/13, D1, Naik) reports that while "companies have been rushing to sell genetic tests directly to consumers" since the "human genome was deciphered seven years ago," a number of the "claims that accompany these tests are not fully supported by science." Oftentimes, the "link between certain genes and a condition can be fuzzy." For example, "some of the most popular tests claim to identify a person's risk of getting a common ailment such as heart disease or diabetes," but the "roots these conditions often lie in multiple genes, many of which scientists think haven't even been discovered yet." Furthermore, certain "[l]ifestyle factors -- such as diet and exercise -- can have an impact on risk" as well. According to some genetic counselors, "people may be no better off when they learn the results" of the tests, because it is not often "clear what" they "should do with the information." The Journal also notes that "most genetic tests are only loosely regulated, and aren't required to provide the type of rigorous scientific studies to back up their claims that the pharmaceutical industry must provide," according to experts.