High-risk groups include children, older adults, and people with compromised immune systems.
FDA's advisory, issued in August, reaffirms similar advice given by the national Centers for Disease Control and Prevention last year. FDA's advisory is among a number of steps the federal government and sprout growers are taking to address safety concerns of alfalfa sprouts.
Raw sprouts have been recognized as a source of food-borne illness in the United States since 1995. In California, they have recently been associated with three Salmonella and E. coli O157:H7 outbreaks affecting about 60 people.
An E. coli O157:H7 infection can cause hemolytic uremic syndrome, which can lead to kidney failure or death in children and equally serious complications in older adults. Salmonella can cause serious illness in children, older adults, and immune-compromised people. In healthy people, these bacteria can cause diarrhea, nausea, abdominal cramping, or fever for several days.
Consumers who have eaten raw sprouts and are experiencing severe diarrhea and other extreme symptoms of food-borne infections should see their health-care providers.
FDA's advisory is an interim measure while the agency and industry look for long-term solutions to ensuring the safety of raw sprouts. In 1997, FDA and CDC charged the National Advisory Committee on Microbiological Criteria for Foods (a scientific panel that advises the government on food safety) with reviewing data on sprout-associated outbreaks and recommending preventive methods. FDA is now working with the U.S. Department of Agriculture's Agricultural Research Service to identify possible interventions, including irradiation.
In addition, FDA has in place a nationwide field assignment to determine current sprout practices during plant growing, washing and packaging and is analyzing samples for microbes. FDA also is meeting with industry groups and the general public to discuss ways to ensure the safety of sprouts.
Sprouts lead beef in E. coli cases . . . Alfalfa sprouts, rather than ground beef, have been found to cause the greatest number of E. coli O157:H7-related illnesses, says the Centers for Disease Control and Prevention. The latest figures show that of the 285 reported cases of illness from the potentially dangerous bacterium, 108 were caused by alfalfa sprouts, while 20 came from eating tainted ground beef. Fifty-two cases of E. coli illness resulted from person-to-person contact, while wading pools accounted for 17.
FDA approved the drug for the skin lesions of a condition called erythema nodosum leprosum based on published literature, the historical experience of the Public Health Service, and other data that showed thalidomide's effect in treating the skin lesions.
The approval comes with unprecedented marketing restrictions to help guard against the severe birth defects that first showed up when thalidomide was marketed outside the United States as a sedative in the 1950s and early 1960s. The product was never approved for use in the United States until now. (See "Giving Thalidomide a Second Chance" in the September-October 1997 FDA Consumer.)
To prevent fetal exposure to thalidomide, the drug's manufacturer, Celgene Corp. of Warren, N.J., has developed the System for Thalidomide Education and Prescribing Safety (STEPS) program. Only doctors who are registered in the STEPS program may prescribe the drug, and both female and male patients must use contraceptives.
Women must use two reliable forms of contraception while on thalidomide and take regular pregnancy tests. Men will get written and oral warnings of the risk of contraception failure and the need to use condoms when having intercourse with women of childbearing age. It is not known if thalidomide is present in semen or if its presence in semen would affect fetal development.
Other possible side effects of thalidomide include a potentially irreversible kind of nerve damage known as peripheral neuropathy, which is more likely if the drug is used chronically for months, and drowsiness and dizziness.
Celgene Corp. will market thalidomide under the brand name Thalomid.
FDA licensed in August the first vaccine to immunize infants against rotaviral infection, a disease that, in the United States, results in the hospitalization of 55,000 infants and children and between 20 and 40 deaths each year. Worldwide, about 870,000 deaths a year are attributed to rotaviral disease.
About 80 percent of American children develop symptoms of rotavirus infection before they turn 5, with the most severe cases occurring before age 3. The oral vaccine is approved for infants in a three-dose schedule at ages 2, 4 and 6 months, when most other childhood vaccines are given. Common side effects include moderate fever, increased irritability, and decreased appetite and activity, all within five days of vaccination.
The vaccine is not recommended for children older than 6 months or for adults. Although adults can get rotavirus infections, most do not become sick or have only mild symptoms.
In controlled trials of about 2,000 infants, the vaccine prevented at least half of all cases of rotavirus disease and at least 70 percent of severe cases.
Wyeth Ayerst Laboratories, Marietta, Pa., will market the rotavirus vaccine under the trade name Rotashield.
A sticky matter . . . Children who are too young to understand the medical implications of swallowing chewing gum shouldn't be allowed to have it, say some doctors. After three young children were brought to the same Florida hospital, to clear wads of gum blocking their digestive tracts, researchers decided the subject needed more attention. One youngster who chewed and swallowed five to seven pieces of gum a day was constipated for two years. (Pediatrics, August 1998)
The Preven Emergency Contraceptive Kit, approved in September, is based on a regimen first described in 1974 in which a woman takes two oral contraceptive pills containing ethinyl estradiol and levonorgestrel within 72 hours of sexual intercourse and two pills 12 hours later. It is 75 percent effective in preventing pregnancy.
FDA's approval is based on a review of the medical literature that showed the regimen is safe and effective in preventing pregnancy when other contraceptive methods fail or when no contraception is used. The regimen does not work if a woman is already pregnant.
Emergency contraceptive pills are thought to work primarily by delaying or inhibiting ovulation.
Common side effects include nausea, vomiting, menstrual irregularities, breast tenderness, headache, abdominal pain and cramps, and dizziness. The risks, contraindications and warnings for emergency oral contraceptive use are the same as for birth-control pills taken daily.
Although certain birth control pills can be used "off-label" to prevent pregnancy following sexual intercourse, FDA's approval of the regimen allows for treatment information to be included in the drugs' labeling.
The kit, which also comes with a urine pregnancy test, will be marketed by Gynetics Inc., Belle Mead, N.J.
(For more on contraceptives, see "Protecting Against Unintended Pregnancy: A Guide to Contraceptive Choices" in the April 1997 FDA Consumer.)
Licensed by FDA Aug. 24, the new product, Remicade (infliximab), is the first approved treatment for Crohn's disease, a chronic, incurable inflammatory bowel disease that causes diarrhea, cramping and abdominal pain, and sometimes opened holes (fistulas) leading from the intestine to the skin.
Traditional treatments have included corticosteroids and other immune-suppressing drugs and antibiotics.
The new product is made from human and mouse cells. A "monoclonal antibody," it works against a protein--tumor necrosis factor alpha--that promotes inflammation in the body.
In one clinical trial, patients benefited most from Remicade two to four weeks following a single dose. Improvement was measured by the number of liquid or soft stools, number and severity of abdominal cramps, and overall sense of well-being. The percentage of patients who maintained benefits decreased over the next few months.
Another clinical trial showed that the treatment reduced for up to five months the number of draining fistulas that some Crohn's patients have.
Though usually temporary, side effects included rash, low blood pressure, chills, chest pain, and some serious infections that responded to antibiotic treatment. Some patients developed antibodies that in rare cases could have been associated with symptoms similar to those seen in patients with systemic lupus erythematosus. This also was temporary.
Remicade is made by Centocor Inc., Malvern, Pa.
Melts in your mouth . . . Migraine sufferers now have a pill they can take either with water or by dissolving on the tongue to ease headache pain. Approved by FDA in June, Maxalt (rizatriptan benzoate) is a prescription drug manufactured by Merck & Co., Inc. and used for short-term treatment of most types of adult migraine attacks. It is not, however, for preventing or decreasing the number of attacks. As many as 23 million Americans suffer from migraine headaches. (For more on migraine, see "Heading Off Migraine Pain," in the May-June 1998 FDA Consumer.)
FDA approved in August the Heart Laser System to treat people with coronary heart disease whose angina (chest pain) cannot be adequately controlled by medicine or effectively treated with balloon angioplasty or other surgical methods. (See "Balloons, Lasers and Scrapers: Help for Hearts and Blood Vessels" in the April 1991 FDA Consumer.) For use only by specially trained surgeons, the laser makes tiny holes in areas of the heart muscle with inadequate blood flow.
Clinical studies showed that 72 percent of patients treated with the laser reported significant reduction in angina pain, an effect that remained when patients were followed up one year later. Only 13 percent of angina patients treated with medicine alone reported the same reduction in pain. Patients were not studied beyond a year.
Risks associated with the laser treatment include major heart arrhythmias (irregular heartbeat), which affected 10 percent of patients in the study, and early death, affecting 3 percent of patients in the study within one month of the procedure. Because of these risks, patients who plan to undergo treatment with the Heart Laser System must sign an informed consent form.
Overall death rate one year after the procedure was performed was similar for patients who received the laser treatment and patients who did not.
The treatment had no effect on the progression of heart disease.
At FDA's request, the manufacturer, PLC Medical Systems Inc., of Franklin, Mass., will conduct a follow-up study to gather additional information on death rates and long-term benefits related to the laser system.
How the laser treatment works is not understood, but it may relate to reduction in perception of pain, formation of new small blood vessels, or increased blood flow to the heart.
Help for stroke victims . . . In an effort to reverse brain damage, doctors at the University of Pittsburgh Medical Center have implanted laboratory-grown human nerve cells, originally obtained from a young man's cancer, into a stroke victim's brain. When implanted into rats whose brains had been damaged by stroke, the cells restored mental function and the use of limbs. Although the stroke victim left the hospital the day after her operation and appeared to suffer no ill effects, doctors believe it will take months before they know if the implanted cells have an effect on her paralysis. Stroke is the leading cause of adult disability and no treatment currently exists to reverse related brain damage.
Relaxed blood vessels . . . The American Heart Association says drugs that lower cholesterol may also prevent heart disease by relaxing the blood vessels. Dilated blood vessels help increase blood flow, which doctors believe may help keep cholesterol from blocking arteries. (Circulation, July 1998)
Approved Aug. 26, DermaBond is similar to commonly used "super glues" but is formulated to be used on skin. It forms a film over wounds and gradually falls off as skin heals.
DermaBond was approved for simple skin-deep wounds that are easily closed, thoroughly cleansed, and not infected. Deeper wounds need to be closed with stitches below the skin before DermaBond can be applied.
FDA approved the product after its advisory panel of outside experts recommended it in January 1998.
DermaBond is made by Closure Medical Corp., Raleigh, N.C.
AIDS drug may combat hepatitis B . . . A drug used to treat AIDS appears also to slow liver damage caused by hepatitis B, says a study of 358 Chinese patients. The study looked at the effects of the drug 3TC on people with longstanding infections by the virus. Signs of liver inflammation fell significantly after a year in just over half of those taking the medicine, compared with one-quarter of those on a placebo. (New England Journal of Medicine, July 1998)
Help for Lyme disease . . . Two similar vaccines being developed by rival drug companies both can help prevent Lyme disease, say two separate studies. But researchers say they don't know how effective the vaccines will be in children, who contract 23 percent of all cases of Lyme disease, or how long the vaccine remains effective. FDA is reviewing both vaccines. (New England Journal of Medicine, July 1998)
The SureStep home blood glucose meters, manufactured by LifeScan Inc. of Milpitas, Calif., may give an error message ("Er-1") instead of "HI" (high) when a person's blood sugar is 500 mg/dL or greater. Such a level is very high and can be dangerous if not recognized and treated. FDA has received reports of two deaths in people whose glucose was very high but who repeatedly got error message readings from the SureStep blood glucose meters and who delayed seeking medical care.
Diabetics who use these meters should continue testing their blood sugar levels because it is far more dangerous not to check blood sugar levels at all than to use a blood glucose meter that may give an unclear message at high glucose levels.
Until all malfunctioning meters have been replaced, LifeScan is sending its customers warning stickers to put on the machines as reminders that the Er-1 message could mean very high blood sugar. Meters with serial numbers beginning with L6000 through L7205 and meters with serial numbers L7206-GA-00001 through L7206-GA-01128 will be replaced. The serial number can be found on the back of the meter.
For further information or to arrange for replacement, call LifeScan's 24-hour customer service line at 1-800-951-7226.
Sweet approval . . . Diet drinks are among nearly a dozen food categories now allowed to contain the artificial sweetener Sunett. FDA approved its use for drinks in June. Known chemically as acesulfame-K, Sunett is 200 times sweeter than sugar and is already used in products such as sugarless chewing gums, instant puddings, tabletop sweeteners, desserts, and dairy mixes. Sunett is calorie-free, can be used in cooking and baking, and does not contain sodium or promote tooth decay.
The supplements, some 5-hydroxy-L-tryptophan (5HTP) products, are being used for insomnia, depression, obesity, and, in children, attention deficit disorder.
While the significance of FDA's finding remains unknown, the agency believes vigilance towards these products is warranted. FDA is unaware of any recent illnesses associated with 5HTP products being sold as dietary supplements; however, the widespread promotion and use of these products began only recently.
In 1991, an impurity associated with 5HTP, called Peak X, was identified in one case of EMS. Impurities similar to Peak X also were found in L-tryptophan that was associated with a 1989 epidemic of EMS. Also, the medical literature includes reports of 10 previous EMS cases worldwide associated with 5HTP products. The exact cause of the 1989 and 1991 cases of EMS remains unclear.
EMS is a serious illness characterized by a rise in certain white blood cells and severe muscle pain. The national Centers for Disease Control and Prevention has identified more than 1,500 cases of EMS, including 38 deaths, associated with L-tryptophan.
FDA is working with CDC and the National Institutes of Health to monitor use of 5HTP products and is consulting with professional and patient groups. The agency encourages the public to report serious adverse reactions to the agency's MedWatch program. To report adverse reactions, professionals and consumers can call 1-800-FDA-1088 (1-800-332-1088). Doctors and other health-care professionals also may send the information by facsimile to 1-800-FDA-0178 (1-800-332-0178) or by mail using a postage paid form to FDA, HF-2, 5600 Fishers Lane, Rockville, MD 20852-9787.
The Food Label . . . In 1994, FDA regulations changed the look of food labels. The reactions of adults in Washington state is illustrated in the chart on the right (select it to see it full size). Researchers asked these consumers how the change affected them. In 1993, 27 percent of men and 43 percent of women said they routinely use food labels (up from 16 percent and 35 percent, respectively, in 1993), but 70 percent said labels are still hard to figure out (down from 75 percent).
Vitamin 'D'-ficiency . . . Researchers at USDA's Human Research Center on Aging say inadequate vitamin D, essential for healthy bones and teeth, is an important health problem for older Americans. In a study involving 759 volunteers, age 67 to 95, about 15 percent of the women and 6 percent of the men had low blood levels of 25-hydroxy vitamin--the most sensitive measure of vitamin D in the body. About 4 percent of the women and 2 percent of the men were deficient. The study also confirmed the importance of eating foods naturally rich in vitamin D, such as milk, fish, egg yolks, liver, and cheese.
To order single copies, write to FDA, Rockville, MD 20857. To order two to 50 copies, write to FDA, HFI-40, at the same address, or fax your order to 301-827-5308. Include the publication number.
FDA Consumer magazine (November-December 1998)
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