Table of Contents
FDA Consumer magazine
September-October 2000
A new type of fetal monitoring device that measures the level of oxygen in the baby's blood during labor and delivery will give more information about the fetus's condition than is possible with currently used electronic fetal monitors.
Conventional monitors measure fetal heart rate and uterine contractions. Health professionals interpret these measurements, along with other factors, to decide if labor can continue, or if a Cesarean delivery is indicated. It's anticipated that being able to monitor the fetal blood oxygen level will give health professionals a more complete picture of how the baby is responding to labor.
The new monitor, the OxiFirst Fetal Oxygen Saturation Monitoring System, was approved by the Food and Drug Administration on May 12, and represents the first major technological development in fetal monitoring since electronic monitoring was introduced in the 1960s and 1970s. The system measures the level of oxygen in the fetus's blood using pulse oximetry, a technology first developed in the 1970s that detects the amount of red and infrared light reflected by oxygen-carrying red blood cells. The device uses a sensor that is inserted into the mother's uterus and placed against the fetus's temple or cheek. It is only to be used along with conventional electronic fetal monitoring when the fetal heart rate is "non-reassuring," meaning that the baby may not be responding normally to the stress of labor. It is intended for use only with single, not multiple, fetuses of at least 36 weeks gestation, where the mother's water has broken and the baby is in the head-down position for delivery.
Studies done before approval assessed whether use of the new monitor would reduce the number of Cesareans done due to a non-reassuring heart rate. These studies showed that the Cesarean rate for non-reassuring heart rate did decline when the OxiFirst monitor was used. But the overall Cesarean rate stayed about the same, because more women using the new monitor had Cesarean deliveries due to difficult or prolonged labor. Analysis of the study data showed that the increase was not related to the device itself. The manufacturer will conduct a large study as the device is used in general medical practice to further understand how its use will impact the Cesarean rate in this country. Currently, about one-fifth of the 3.9 million births in the United States each year are Cesarean deliveries.
The rate of adverse events in pre-approval studies was comparable between births using the OxiFirst monitor and those managed with conventional monitoring, showing that the monitor is safe for both mother and baby.
The OxiFirst Fetal Oxygen Saturation Monitoring System is manufactured by Mallinckrodt/Nellcor Perinatal Business, Pleasanton, Calif.
The popular antidepressant Prozac now has another use and another name. FDA approved fluoxetine (Sarafem) in July for the treatment of Premenstrual Dysphoric Disorder (PMDD). Fluoxetine was approved in 1987 under the name of Prozac for treating depression, and has also been approved for treating obsessive-compulsive disorder and bulimia. The manufacturer, Eli Lilly, of Indianapolis, Ind., renamed the drug Sarafem for its new use to treat PMDD.
A woman is diagnosed with PMDD when she experiences at least five of eleven symptoms regularly between ovulation and menstruation (about one to two weeks before her period). One of the five symptoms must be: markedly depressed mood, noticeable anxiety or tension, sudden sadness or tearfulness, or persistent anger or irritability. The other symptoms may include: decreased interest in activities, difficulty concentrating, lack of energy, change in appetite, sleeping too much or too little, a sense of being overwhelmed, or physical symptoms (headache, joint and muscle pain, weight gain, bloating, or breast tenderness).
"Women who have PMDD are likely to miss work or school, and have increased interpersonal and domestic problems," says Thomas Laughren, M.D., a medical officer in FDA's Center for Drug Evaluation and Research. The symptoms of PMDD are more severe than those of premenstrual syndrome (PMS), according to Laughren. About 3 to 5 percent of women of child-bearing age are estimated to have the condition.
Available by prescription only, Sarafem comes in packages of 28 pills and is priced the same as Prozac, according to the manufacturer. The drug is to be taken daily--not just on the days the patient isn't feeling well.
In studies, Sarafem was found to be significantly more effective than a placebo. Its effectiveness in women taking birth control pills is not yet known, since this group was excluded from the studies. Side effects of the drug include nausea, tiredness, nervousness, dizziness, and difficulty concentrating.
A new cancer drug may extend the lives of some leukemia patients who are poor candidates for more traditional chemotherapy. The Food and Drug Administration approved Mylotarg for older patients with CD33 positive acute myeloid leukemia whose cancer has returned after chemotherapy treatment. Patients with this type of leukemia quickly accumulate abnormal white blood cells in the blood and bone marrow, causing severe anemia, infection, and hemorrhage during the course of the disease. Acute myeloid leukemia is more commonly found in older adults, and requires aggressive, immediate treatment.
The standard treatment for leukemia, chemotherapy, is given in the hospital for seven days and requires the patient to remain in the hospital for an extended period of time following treatment. The new Mylotarg treatment, which is given in place of chemotherapy, is a two-hour intravenous infusion delivered in two doses, 14 days apart. Although it does not always require a hospital stay, the majority of patients are hospitalized over the course of treatment.
Mylotarg works by attaching itself to an antigen found on the surface of the tumor cells. Antigens are proteins that the body's immune system recognizes as foreign and destroys. The leukemia cells then die after absorbing the drug's toxic chemical. The major side effects of Mylotarg include prolonged myelosuppression (inhibited bone marrow activity causing decreased production of blood cells and platelets) and liver toxicity. Rare allergic reactions have also been reported.
The drug is approved only for patients 60 years and older, since the prognosis in younger patients may be better with conventional treatments.
Mylotarg (gemtuzumab ozogomicin for injection) is manufactured by Wyeth-Ayerst of Philadelphia, Penn.
Most parents of overweight children do not consider them to be overweight, say researchers from the Bassett Healthcare Research Institute in Cooperstown, N.Y., and Columbia University. This conclusion was drawn from a survey of over 1,400 parents or guardians of children aged 1 to 5 who were participants in the Supplemental Nutrition Program for Women, Infants, and Children (WIC) in New York state. Study results were reported at the Pediatric Academic Societies 2000 meeting in Boston.
The researchers found, for example, that 68 percent of parents of children with a Body Mass Index above the 95th percentile, which is considered to be obese, reported that their child's weight was "OK, just right" and 8 percent even reported their child was "underweight." Body Mass Index, or BMI, is a measurement of overweight and obesity that is calculated using height and weight.
In other results of the study, the researchers found that the prevalence of childhood obesity was more than twice as high as the national rate in the 1970s. Lead researcher Barbara A. Dennison, M.D., observed that, where one would expect about 15 percent of all children to be overweight, instead more than 35 percent of the children in the study were overweight. "Increasing rates of child obesity have been noted before, but these rates are even higher than previously reported," Dennison noted.
The study also suggested that parents of obese children who believe their child is overweight more often limit how much food their child eats and they report more frequently using dessert as a reward for finishing dinner. Researchers found, in addition, that overweight children watched significantly more television than non-overweight children, and that the risk of being overweight was directly related to the number of hours of television per week that the children watched. (Pediatric Academic Societies, May 14, 2000)
"Ad Nauseam," a campaign launched in May by the Partnership for Healthy Weight Management, focuses attention on dubious weight-oss claims and the media that carry advertisements touting the claims. The Partnership is a coalition of scientific, academic, health-care, government, commercial, and public interest representatives that promotes the responsible marketing of weight loss products and programs. Its other goals include encouraging more effective screening of ads for weight-loss products and services, and increasing public awareness of the obesity epidemic in the United States.
To launch the Ad Nauseam campaign, the Partnership contacted nine major media sources that carried 12 dubious weight-loss claims, asked the publications to explain their ad screening policies, and urged them to adopt policies that require proof of extravagant claims. The Partnership contacted the magazines Cosmopolitan, Esquire, McCall's, Redbook, and Woman's Day, The Atlanta Journal-Constitution, The [Denver] Rocky Mountain News, USA Today, and Smart Source. Only one publication, USA Today, responded to this inquiry, and no publishers provided information showing an effective ad screening policy. The Partnership will follow up by encouraging all mainstream media to demand proof before accepting advertising copy that contains extravagant promises of weight-loss success.
The public is invited to assist by collecting examples of dubious ads and sending them to the Partnership for Healthy Weight Management, Federal Trade Commission, S-4302, 601 Pennsylvania Ave., N.W., Washington, DC, 20580. Or call FTC's toll-free helpline at 1-877-FTC-HELP (1-877-382-4357), or e-mail the information using FTC's online complaint form at https://www.ftc.gov/ftc/complaint.htm.
Consumers can get the Partnership's brochure, "Finding a Weight Loss Program that Works for You," from the Partnership's Website at www.consumer.gov/weightloss/. Copies can also be requested by writing to the FTC mailing address above.
Caffeine drinks such as cola, coffee and tea may lower the risk of developing Parkinson's disease (PD). Researchers at the Veterans Administration Medical Center in Honolulu can't explain how beverages that make people jittery can help prevent a disease that results in tremors. Nevertheless, they found that men who drank coffee were less likely to get PD. And the more coffee they drank, the better. Non-coffee-drinking men were two to three times more likely to get PD than those who drank from 4 ounces to 28 ounces a day. But they were five times more likely to develop PD than those who drank 28 ounces or more a day, or about 4 1/2 6-ounce cups.
Caffeine was identified as the protective ingredient in coffee after niacin and eight other nutrients were determined to be unrelated to PD. The addition of milk or sugar to coffee did not make any difference in the findings.
Lead researcher G. Webster Ross, M.D., suggests several theories to explain the findings. Men who have a propensity to develop PD may have an intolerance to caffeine. Another possibility is that caffeine may protect against the nerve cell destruction that causes PD.
The findings were based on data from the Honolulu Heart Program, an ongoing study of 8,004 Japanese-Americans, which began in 1965. As the study considered only men with this ethnic background, the researchers said it is unclear whether the same results would be found in women and other ethnic groups. "It is too early to recommend coffee drinking to prevent Parkinson's disease," says Ross. (Journal of the American Medical Association, May 24/31, 2000)
Carbonated beverages and physical activity may not mix, according to a study by the Harvard School of Public Health and Harvard Medical School. The study concluded that active girls who drink carbonated beverages, especially cola, are five times more likely to have bone fractures than those who don't drink these beverages. The study was done on 460 ninth- and tenth-grade girls who reported their activity levels, carbonated beverage drinking habits, and history of bone fractures. The greatest increases in likelihood of bone fractures were for those who drank carbonated beverages and engaged in high-level or vigorous physical activity. In previous studies, the researchers also found a similarly strong relationship between carbonated beverage consumption and bone fractures in active postmenopausal women and teenagers.
The researchers don't know why this occurs, but allow for the possibility that cola and other carbonated drinks contain phosphoric acid, which affects calcium metabolism and bone mass. Another theory is that more young people replace milk in their diets with soda, giving bodies less calcium with which to build strong bones. (Archives of Pediatric and Adolescent Medicine, June 2000)
A surgical "glue" recently approved by FDA offers a new option for patching air leaks that commonly occur in patients' lungs after the removal of cancerous tumors.
Approved in May after an expedited review of safety and effectiveness studies, the FocalSeal-L Surgical Sealant can complement standard tools for closing air leaks, such as stitches and staples. The product is painted on the lung and forms a seal after light activates a chemical process called polymerization.
The main clinical study of FocalSeal involved 180 patients being treated at four U.S. medical centers. Of the 125 patients treated with FocalSeal plus standard sealing techniques, 39 percent remained free of air leaks through their discharge from the hospital, compared to 11 percent of the 55 patients who received only standard treatments.
Side effects were similar in the two groups, but infections were more frequent in FocalSeal patients.
FocalSeal is made by Focal Inc., Lexington, Mass. As a condition of approval, the company will conduct five years of follow-up studies to see whether the product affects the rate of cancer recurrence.
A manufactured skin made from living human cells is now available to help heal open wounds in the feet of individuals with diabetes. Previously approved in 1998 to treat leg ulcers caused by circulatory problems, Apligraf was approved by the Food and Drug Administration in June to treat hard-to-heal diabetic foot ulcers. /p>
Apligraf is a wound dressing that contains human skin cells combined with collagen from cattle to simulate human skin. This skin substitute is bi-layered; that is, it has both an upper epidermal and a lower dermal layer. Its unique composition is purported to protect the wound while promoting the growth of new, healthy skin. /p>
Apligraf is to be used along with standard procedures for treating diabetic foot ulcers, which include cleansing the wound, treating infection, and keeping weight off the affected foot.
In clinical studies of 208 patients, 112 were treated with Apligraf and standard care and 96 were treated with standard care alone. After three months, 56 percent of the patients in the Apligraf group had complete wound closure compared to 39 percent of the patients who received the standard care alone. More than 80 percent of the ulcers remained closed after four weeks for both groups.
Apligraf is manufactured by Organogenesis Inc. of Canton, Mass.
Magnetic resonance imaging (MRI) can accurately detect re-narrowed heart arteries in patients who have had balloon angioplasty or other artery-clearing procedures, according to researchers at Wake Forest University Baptist Medical Center and the University of Texas Southwestern Medical Center. The researchers tested 17 patients with chest pain at least three months after balloon angioplasty. Testing was done with both non-invasive MRI and invasive heart catheterization. Catheterization, which is the current standard test to evaluate artery blockage, involves passing a tube through the blood vessels into the heart, releasing dye into the vessels, and taking x-rays to view any narrowing. The two tests were found to be equally accurate at detecting blockages.
One-third of the people who undergo balloon angioplasty will develop re-narrowed arteries within six months, according to the American Heart Association.
Although this study applies MRI technology to patients with re-narrowed arteries, researchers predict it can also be used in seemingly healthy people to detect heart disease in time to prevent heart attacks or angina. (Circulation, May 23, 2000)
Mosquitoes seem to be attracted to pregnant women, according to scientists at the University of Durham, England, and the Medical Research Council, Gambia, who found that pregnant women are bitten by mosquitoes twice as often as non-pregnant women. The particular mosquito studied was the African malaria-carrying mosquito. The researchers suggest that the physiological changes that take place during pregnancy could cause the increased mosquito-biting. For example, women in later stages of pregnancy exhale greater volumes of air than non-pregnant women, and the several hundred components in exhaled human breath may help mosquitoes track their targets. In addition, mosquitoes can zoom in on the bacteria that form on the warm skin of pregnant women, who have a slightly higher body temperature and sweat more easily.
The researchers hope these findings will lead to the development of more effective repellents that block the mosquito-attracting odors. The study, which took place in rural Gambia, shows that pregnant women in this part of the world are at increased risk for malaria, a disease that kills over 1 million people each year. (The Lancet, June 3, 2000)
If your child could be infected with E. coli bacteria (found, for example, in raw or undercooked hamburger), get expert medical advice before giving antibiotics, say researchers at the University of Washington School of Medicine. A study found that children with gastrointestinal infections from the E. coli O157:H7 strain of bacteria are seven times more likely to develop a potentially fatal kidney disease, hemolytic uremic syndrome (HUS), when given antibiotics. HUS developed in five of the nine children in the study infected with O157:H7 and given antibiotics (56 percent) as compared with five of the 62 children who were infected and not given antibiotics (8 percent). The researchers suspect that antibiotics cause the toxic bacteria to be released from the intestine, making the toxin more available for absorption by the body. Antibiotics should not be given, they add, until a stool culture rules out E. coli infection.
FDA reports that up to 15 percent of all people who get hemorrhagic colitis, the acute disease caused by O157:H7, develop HUS, which can lead to permanent kidney failure and death.
Symptoms of E. coli O157:H7 bacterial infection include bloody diarrhea, severe abdominal cramps, and dehydration. It can occur a few days after eating bad meat, raw milk, contaminated water, unpasteurized ciders and juices, or tainted produce. (New England Journal of Medicine, June 29, 2000)
Dogs love them. They're blissfully chewy and delightfully smelly to your pet--but treats made from the leftover parts of food-producing animals can make you and your family very sick.
Pet treats made from the dried ears, hooves, lungs, and bones of pigs and cows have been implicated in Salmonella poisoning in humans. In late 1999, Canadian health officials alerted the Food and Drug Administration to more than 35 human cases of Salmonella poisoning that occurred in Canada over the past year and were linked to contact with pig ears produced in that country. Some of these illnesses required children to be hospitalized.
"It's alarming to find that number of serious illnesses," says Gloria Dunnavan, the director of the Division of Compliance in FDA's Center for Veterinary Medicine. "We want to make sure there is no Salmonella in dried animal parts being sold as pet treats in the United States."
Earlier this year, FDA alerted U.S. distributors of both the suspect Canadian products and U.S.-manufactured dried animal parts. After U.S. retail store Costco tested and found Salmonella in samples of Medalist brand pig ears produced in this country, manufacturer Treat Makers L.L.C. recalled the products in May. The recall covers treats sold at Costco stores in 11 states: Washington, Oregon, California, Arizona, New Mexico, Nevada, Utah, Colorado, Idaho, Montana, and Hawaii. The products are packaged in 25-count plastic bags and stamped with lot numbers 07600EXU3 or 08300EX01 on a white sticker on the back of the bag.
In June, another U.S. manufacturer, Products Carousel, Inc., recalled its Pets Carousel 100% Choo-Hooves Pressed Sticks--Item #90010-S because of possible contamination with Salmonella. The Pets Carousel products were sold by Petsmart in Ohio and Arizona.
Although no illnesses from these products have been reported in the United States, consumers should handle dried animal parts like they would handle raw meat, according to Dunnavan. In other words, wash your hands with soap and hot water after handling, avoid putting the treats on food contact surfaces (such as kitchen countertops), and don't allow children to touch their mouths after handling until they've washed their hands. Dunnavan also advises consumers not to purchase unpackaged dried treats, which are more likely to be contaminated by Salmonella.
While healthy pets rarely become ill from the bacteria, they can become carriers of Salmonella and infect humans or other animals. This means that you could become infected if Fido licks your face after chewing a contaminated product.
Salmonella can cause vomiting, diarrhea, fever and stomach cramps in otherwise healthy individuals and can be fatal in young children, the elderly, or people with weakened immune systems.
Consumers may return the recalled Medalist and Pets Carousel products to the store where they purchased them for a full refund. Customers with questions about the recall should call Treat Makers at 1-888-250-7369 or Products Carousel at 800-231-3572. FDA continues to work with pet treat manufacturers to investigate the cause of the problem and ways to prevent it in the future.
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