The FDA has approved the GlucoWatch G2 Biographer (Cygnus Inc, Redwood City, Calif), a glucose monitoring device, for the detection and assessment of episodes of hyperglycemia and hypoglycemia in children and adolescents aged 7 to 17 years old. The device had been previously approved for the same use in adults.
The Biographer, which is worn like a wristwatch, obtains a glucose sample by periodically applying a very low level of electrical current to the skin. The sample is painlessly extracted into hydrogel disks that contain glucose oxidase, and the resulting hydrogen peroxide reacts on a platinum biosensor to produce an electric signal that is translated into an equivalent blood glucose level.
The safety and effectiveness of the Biographer in a juvenile population was demonstrated in a controlled, 15-hour clinical study with 66 persons aged 7 to 17 years with type 1 diabetes mellitus. The participants were unrestricted in their activities and wore up to three Biographers each, which automatically measured glucose levels every 10 minutes. The values were compared with hourly matching finger stick glucose meter results.
The study showed that, in general, the device values reflected those of finger stick glucose meter results, but up to 25% of the readings differed significantly (≤30%, or 20 mg/dL). Because these variations are unpredictable, the Biographer should be used only to supplement, not to replace, information obtained from standard home glucose monitoring devices. Interpretation of Biographer results should be based on the trends and patterns shown in several sequential readings.
The FDA has issued a guidance on its approach to regulating compounded drugs following court decisions that have invalidated the pharmacy compounding section 503A of the Food, Drug and Cosmetic Act.
The guidance does not affect the legitimate pharmacy compounding of reasonable quantities of human drugs on the receipt of valid prescriptions for individual patients. The document warns, however, that the FDA may seriously consider enforcement action if the scope and nature of a pharmacy's activities result in significant violations of rules protecting the integrity and labeling of pharmaceuticals.
Examples of potential violations include the following: excessive compounding of drugs in anticipation of receiving prescriptions; compounding drugs that were withdrawn or removed from the market for safety reasons; compounding finished drugs from bulk active ingredients that are not components of FDA-approved drugs; receiving, storing, or using drug components not guaranteed to meet official compendia requirements; using commercial scale manufacturing or testing equipment for compounding drugs; and compounding drugs for resale by third parties, or offering compounded drugs at wholesale to commercial entities. The guidance, which is open for comments, is posted on the Internet at http://www.fda.gov/ora/compliance_ref/cpg/default.htm.
In response to the results of the Women's Health Initiative (WHI) study of the combination of conjugated equine estrogen/medroxyprogesterone acetate (Prempro), the FDA reminds physicians that the drug is currently approved for three indications: treatment of moderate-to-severe vasomotor symptoms associated with the menopause; treatment of vulvar and vaginal atrophy; and prevention of postmenopausal osteoporosis.
Although the stopped WHI study did not target symptomatic women or those at risk for osteoporotic complications, it does provide data on the long-term risks of Prempro in postmenopausal women. They include increased risks of breast cancer and thromboembolic disease associated with estrogen and combination estrogen/progestin therapy, as well as increased risk of cardiovascular disease, including myocardial infarction and stroke, in healthy women.
Women taking Prempro or other combination estrogen/progestin therapy should consult with their physicians about the relevance of this new information to their treatment. Because of differences in estrogenic potency and product composition, it is not known whether the new findings about risks can be generalized to other combination estrogen/progrestin products. The long-term risks of lower doses of Prempro were not evaluated in the WHI trial.
The FDA and the NIH will host public sessions to be announced on their respective Web pages at http://www.fda.gov/cder/drug/safety/WHI_statement.htm and http://calendar.nih.gov. The meetings will consider the extent to which the WHI results might be extrapolated to other combination estrogen/progestin products and doses, assessment of known benefits for approved indications in the light of these new data, and the WHI trial's implications for future clinical trials of hormonal therapy.
The FDA has posted information on the Internet about the use of its authority in instances when it appears that a clinical investigator's misconduct poses ongoing risk to the safety and welfare of human subjects in a study involving human drug or biological products. For full text, see http://www.fda.gov/cber/guidelines.htm.
Written inquiries may be directed to Office of the Commissioner of Food and Drugs, HF-1, Room 14-71, 5600 Fishers Ln, Rockville, MD 20857.
Country-Specific Mortality and Growth Failure in Infancy and Yound Children and Association With Material Stature
Use interactive graphics and maps to view and sort country-specific infant and early dhildhood mortality and growth failure data and their association with maternal
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