U.S. Food and Drug Administration
FDA Consumer magazine
March-April 2001
Table of Contents
Type 2 diabetes is characterized by abnormal handling of nutrients by the body, particularly sugar (glucose). This is caused by a combination of an inability to produce sufficient insulin, as well as to respond fully to the insulin that is produced. In addition to elevations in fasting glucose, people with Type 2 diabetes have an ineffective response to the rise in blood sugar (glucose) that occurs normally after eating a meal.
In December, FDA approved Starlix (nateglinide), an amino acid derivative and the second in a relatively new class of oral drugs that stimulates the patient's pancreas to secrete additional insulin. In this respect, Starlix shares a common mechanism of action with a much older class of drugs called sulfonylureas (glyburide and glipizide, for example). Starlix and the related drug Prandin (repaglinide), differ from the sulfonylureas in their relatively rapid onset and short duration of action. As such, if taken three times daily immediately before meals, they exert their glucose-lowering effects mostly on the fluctuations in blood sugar that follow in the several hours following each meal.
Starlix alone has quite modest effects on overall glucose control. When given in combination with another diabetes drug, Glucophage (metformin), the two drugs give greater control of blood sugar than either drug alone (that is, the effect appears approximately additive).
Starlix and Prandin at recommended doses generally will have less effect on glucose control than sulfonylureas. Because of Starlix's modest efficacy, the incidence of hypoglycemia, the main acute complication of therapy aimed at lowering blood glucose in Type 2 diabetes, was low in the clinical trials of the drug. Starlix is made by Novartis AG of Basel, Switzerland.
Glucose control can help prevent serious complications of diabetes, such as kidney failure, blindness, and amputations. To control their blood sugar, people with diabetes must frequently test their blood glucose levels. Of the many types of home blood-glucose monitors available to help patients manage their diabetes, Sof-Tact is one of the most recent to come on the market. Manufactured by Abbott Laboratories of Bedford, Mass., and cleared by FDA in November, Sof-Tact is a semi-automated system that uses a light-suction vacuum to hold the skin in place while an integrated apparatus lances the skin. The device automatically transfers a small amount of blood to a biosensor strip, and the blood glucose test result is delivered in 20 seconds. The device can be used on the forearm or upper arm, eliminating the need for the traditional finger-sticking method.
Nearly 16 million people in the United States, or 6 percent of the population, have diabetes, according to the American Diabetes Association. Approximately 90 to 95 percent of diabetes patients have Type 2 diabetes.
FDA has approved a new treatment for eczema, a skin condition that can cause redness, itching, and oozing lesions. Protopic Ointment is for patients with moderate to severe eczema who are unable to tolerate or benefit from standard eczema therapies.
FDA based its approval on results of three 12-week studies that indicated that 28 to 37 percent of patients using Protopic experienced greater than or equal to 90 percent improvement of their skin condition. Two one-year studies indicated the drug is safe for intermittent long-term use. Common side effects associated with this drug include temporary stinging or burning sensations where the drug is applied.
An animal study revealed that Protopic Ointment may accentuate adverse effects of ultraviolet light on the skin. So patients should avoid sunlight and sunlamps, tanning beds, and treatment with ultraviolet A (UVA) or ultraviolet B (UVB) light. Patients who need to be outdoors after applying Protopic should wear loose-fitting clothing that protects the treated area from the sun. Patients should also ask their health-care providers about other sun protection to use.
Protopic Ointment should not be used by patients who are allergic to its active ingredient, tacrolimus, or to its inactive ingredients. Women who are breast-feeding should also avoid using the ointment, and women who are pregnant or planning to become pregnant should check with their physicians before using this product.
Protopic will be marketed by Fujisawa Healthcare Inc. of Deerfield, Ill.
FDA has proposed a new, user-friendly format for the package inserts that give physicians information on prescription drugs. FDA believes the new labeling format will help reduce medical errors in drug prescribing.
Product labeling represents a primary way to share critical drug information with physicians, and one FDA study revealed that practitioners found current labeling lengthy, complex, and hard to use.
The proposed labeling will cut down the time physicians spend looking for information and make it easier to spot warnings. One major proposed change is the addition of a bulleted "Highlights" section that would include information that practitioners consider most important and need to refer to frequently.
Because these labeling changes are most critical for newer and less familiar drugs, the proposal will apply only to relatively new prescription drug products. FDA reviews and approves drug product labeling that manufacturers propose.
FDA Consumer previously reported on the risk of people getting antibiotic-resistant bacteria from eating poultry or other food contaminated from contact with raw poultry that has been treated with a fluoroquinolone (antibacterial) drug. (See "Antibiotic Resistance From Down on the Chicken Farm," January-February 2001 FDA Consumer.) FDA's Center for Veterinary Medicine (CVM) proposed to withdraw approval of Bayer Corporation's fluoroquinolone product, Baytril, for use in poultry. This action was based, in part, on a national surveillance program that showed an increasing number of drug-resistant Campylobacter infections in people who ate poultry or other food contaminated by poultry treated with the drug.
The company was originally required to submit data and information by Jan. 2, 2001, to support its request for a hearing to keep its drug on the market. CVM has extended the deadline to Feb. 21 because some of the data cited in the Notice of Opportunity for Hearing (NOOH), published in the Federal Register Oct. 31, 2000, were found to be incorrect. These data were taken from a CVM risk assessment entitled "The Human Health Impact of Fluoroquinolone Resistant Campylobacter Attributed to the Consumption of Chicken," published Oct. 18, 2000. CVM discovered that corrections were needed in the risk assessment model, which affected the estimate of the number of persons infected with fluoroquinolone-resistant Campylobacter from chicken and subsequently prescribed a fluoroquinolone.
As a result of the correction, along with incorporation of final data from a database called FoodNet, the estimated number of persons infected with fluoroquinolone-resistant Campylobacter from chicken who were prescribed a fluoroquinolone drug in 1999 was 9,261 (revised from 11,477).
CVM does not believe that the revisions alter the premise of the NOOH. The Center has made the risk assessment and the program to run the calculations publicly available through its Web site at www.fda.gov/cvm/antimicrobial/Risk_asses.htm.
Consumers are still satisfied with FDA's performance in food labeling and with its consumer alerts on food safety issues, according to the second government-wide customer satisfaction survey released in December. Consumers also continue to trust FDA to ensure food safety. The agency received an index score of 68, just slightly above last year's rating.
Survey questions targeted principal grocery shoppers and food preparers, and asked about FDA's mission to ensure food safety, the usefulness and clarity of nutrition labeling, customer awareness, and views of effectiveness of inspecting, testing, and labeling efforts. As in the 1999 report, the survey calls for an increase in public awareness of how FDA food safety activities affect consumers.
Initiated last year by the National Partnership for Reinventing Government, this survey was developed to measure how well key government agencies serve the public and to set a baseline for measuring customer satisfaction. The University of Michigan conducted the survey using a model established for the American Customer Satisfaction Index, which measures satisfaction with various industries.
Talking on cell phones isn't linked to an increased risk of brain cancer, suggests a recent study supported by Wireless Technology Research and the National Cancer Institute.
Researchers interviewed 469 men and women aged 18 to 80 with brain cancer and 422 matched controls without brain cancer between 1994 and 1998. Researchers asked subjects if they had ever subscribed to a cell phone service, and they gathered such information as the number of years of use, the amount of time used per month, and the year of first use.
The median number of hours per month of cell phone use was 2.5 for the cancer patients and 2.2 for those without cancer. The mean duration of use was 2.8 years for cancer patients and 2.7 years for those without cancer. The differences between the cancer patients and those without the disease were not statistically significant. Researchers concluded there was no association with brain cancer according to duration of use, but also stated that more studies on long-term use of cell phones are needed. (Journal of the American Medical Association, Dec. 20, 2000)
Women who suffer from migraine headaches are more likely to experience a migraine in the four days closest to the onset of their menstrual periods, according to recent research. The study, conducted by researchers at the Johns Hopkins School of Hygiene and Public Health and several other institutions, was one of the few that have looked into the relationship between migraines and women's menstrual cycles in the general population.
Researchers had 81 migraine sufferers, selected randomly from households in Baltimore County, Md., keep diaries that documented when in their menstrual cycles their migraines occurred, noting specific symptoms and the severity of the headaches. Women experienced headaches without aura (the visual and physical symptoms that sometimes presage a migraine) more than two times more often in the two days after the start of menstruation. Participants did not have the same cyclical increase in headaches with aura. The study group also had an increase in tension-type headaches at the onset of menstruation. Migraines that occurred at this time, however, were not more severe than those experienced at other times.
Researchers concluded that the women's cyclical hormone changes, especially the drop in estrogen levels that occurs just before menstruation, are a trigger for migraines without aura, and that tension-type headaches may be triggered in the same way. (Neurology, Nov. 28, 2000)
Serious Product Problem? Report ItHealth professionals can report serious adverse reactions or other product problems to FDA's MedWatch program by:
FDA encourages consumers to report through their doctors, but if they prefer, they may submit the MedWatch form themselves. |
Pregnant women who drink five or more cups of coffee a day may double their risk of miscarriage, according to a new study that examined the relationship between miscarriage and consumption of caffeine. Researchers in Sweden and the United States compared the caffeine intake of a group of Swedish women who had miscarriages in early pregnancy with that of women who had normal pregnancies. Consuming the amount of caffeine in one to three cups of coffee raised miscarriage risk by 30 percent; three to five cups, by 40 percent.
These conclusions support results of previous studies that showed increased miscarriage risk from high caffeine consumption. Researchers also collected data on smoking by mothers and whether fetuses had genetic abnormalities, two separate factors that increase the risk of miscarriage. They concluded that caffeine consumption could increase miscarriage risk for genetically normal fetuses. Because they couldn't determine how smoking would change the risk for caffeine drinkers, the study's conclusions are made only for non-smoking mothers.
The researchers acknowledged, in addition, that study results could be skewed because morning sickness in early pregnancy may affect how much caffeine is consumed. Mothers with healthy fetuses tend to have more severe nausea, and often develop an aversion to coffee, so women with less viable pregnancies may be able to drink more coffee without discomfort. (New England Journal of Medicine, Dec. 21, 2000)
Caffeine is a natural component of coffee, tea, and chocolate. It is added to some soft drinks, and appears in the ingredient listing on the label when it is added to a food product. Some over-the-counter and prescription medicines contain caffeine, as well. FDA has advised women since 1980 to avoid caffeine or consume it only moderately throughout pregnancy.
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