Table of Contents
FDA Consumer magazine
September-October 1999
Based on increasing reports of illnesses, FDA said in a July advisory that anyone who wants to reduce the risk of food-borne illness should not eat raw sprouts.
FDA advises all consumers to take these precautions:
This advice is particularly important for children, the elderly, and persons with weakened immune systems, all of whom are at high risk of developing serious illness due to food-borne disease. Sprouts can cause potentially dangerous Salmonella and E. coli O157 infection.
The July advisory updates one issued in August 1998 and is based on additional information from three salmonellosis outbreaks associated with clover and alfalfa sprouts from January through May 1999. These sprouts have been the most common causes of outbreaks, but all raw sprouts may pose a risk.
While Salmonella and E. coli O157 can cause serious illness in some people, the infection usually runs its course in healthy adults without causing serious illness. People who eat raw sprouts and have diarrhea or other symptoms of food-borne infections should see a health professional.
The sprout industry, government, academia, and others are working to enhance sprout safety by focusing on seed treatment strategies, good manufacturing practices, and sanitation. FDA will continue to monitor sprout safety closely.
(For more information about sprout safety, see "Questions Keep Sprouting About Sprouts" in the January-February 1999 FDA Consumer.)
A plan to add safe handling instructions for consumers to the labels on egg cartons is one of three new measures FDA and the U.S. Department of Agriculture are taking to prevent illnesses caused by contaminated eggs.
FDA has proposed the following label instructions to warn consumers about the risk of Salmonella enteritidis (SE), a bacterium that can occur in raw eggs:
"SAFE HANDLING INSTRUCTIONS: Eggs may contain harmful bacteria known to cause serious illness, especially in children, the elderly, and persons with weakened immune systems. For your protection: Keep eggs refrigerated; cook eggs until yolks are firm; and cook foods containing eggs thoroughly."
FDA also is proposing that retail establishments, such as supermarkets, restaurants, delis, caterers, vending operations, hospitals, nursing homes, and schools, keep eggs refrigerated at 45 degrees Fahrenheit (7.2 degrees Celsius) or below. The Food Safety and Inspection Service (FSIS) of the U.S. Department of Agriculture will require warehouses and other distribution locations to store shell eggs that are packed in containers destined for consumers at 45 F or below. This requirement also would apply to vehicles that transport shell eggs.
A joint government study found that refrigeration makes it more difficult for SE bacteria to grow.
Finally, the President's Council on Food Safety will develop by Nov. 1 a plan on how to control pathogens, including SE, and suggest further steps to ensure egg safety from the farm to the table.
The measures, announced July 1, are designed to prevent as many as 66,000 illnesses and 40 deaths a year from SE. Eating raw or undercooked eggs contaminated with SE can cause diarrhea, fever, stomach cramps, headache, nausea, and vomiting, and, in susceptible people, severe and life-threatening illness.
Regulation of egg safety falls to FDA and FSIS, with FDA having primary responsibility for shell eggs. Though the government's Food-borne Diseases Active Surveillance Network (FoodNet) reports that the number of SE illnesses has dropped 44 percent from 1996 to 1998, raw and undercooked eggs served in homes, private gatherings, and commercial establishments continue to be sources of SE outbreaks.
(For more on egg safety, see "Safer Eggs: Laying the Groundwork" in the September-October 1998 FDA Consumer.)
FDA announced last summer that certain foods and animal feeds from Europe would be detained at U.S. ports of entry until tests showed that the products were free of detectable levels of two potentially cancer-causing substances.
The products to be detained included all eggs, egg-containing foods, and cheese, from Belgium and all animal products from certain European countries. The animal products included animal-derived medicated and nonmedicated feeds, feed ingredients, and pet foods.
FDA's announcement followed reports of possible contamination of European animal feed with polychlorinated byphenyls (PCBs) and dioxins--groups of compounds that may cause cancer at low levels of exposure over a long period and may have other toxic effects.
FDA took its action as a precaution and believes that exposure of U.S. consumers to harmful levels of PCBs and dioxins is minimal.
The chemicals are believed to have entered the food chain in January 1999 when they contaminated a fat product from a rendering company in Europe. (Rendering companies process livestock carcasses for use in various products.) The fat was sold to feed manufacturers in Belgium and possibly in France and the Netherlands.
Food-producing animals may have eaten contaminated feed, resulting in potentially contaminated food for human use. Carcasses of food-producing animals that ate the contaminated feed also may have been rendered and the renderings added to animal feed shipped to other European countries, thereby possibly contaminating feed for animals. For this reason, FDA decided to detain all animal-derived feed and feed ingredients, as well as pet food, imported from Europe.
The U.S. Department of Agriculture held poultry and pork from all European Community countries for export to the United States because of the possibility that livestock may have been fed contaminated feed.
The manufacturer of the prescription antihistamine Hismanal (astemizole), Janssen Pharmaceutica Inc., Titusville, N.J., announced in June that it was voluntarily withdrawing the drug from the market. FDA supports the move because other prescription antihistamines are now available and because the drug's risks outweigh its benefits.
Since Hismanal's approval in 1988, it has required a series of label changes and warnings. Patients who took the drug for their allergy symptoms should consult their doctors about an appropriate treatment alternative.
Folic acid levels up ... Researchers have seen a substantial rise in folic acid levels in middle-aged and older adults since January 1998 when FDA required food manufacturers to fortify enriched grain products with the vitamin. Average folic acid levels in 1,106 people nearly doubled after fortification. Fewer than 2 percent still had folic acid deficiency, compared with 22 percent prior to adding the vitamin to products such as flour and rice. Folic acid is necessary to the formation and development of blood cells. (The New England Journal of Medicine, May 1999)
Reducing cancer risks further ... Increasing the daily recommended dietary allowance (RDA) for vitamin C from 60 milligrams to between 100 and 200 mg may help lower cancer risks, say researchers at the National Institutes of Health. Extensive data show that since 1988, when the last RDA was published, diets with 200 mg or more of vitamin C from fruits and vegetables are associated with lower cancer risks of the esophagus, stomach, oral cavity, colon, and lung. (Journal of the American Medical Association, April 1999)
Sunscreen products will soon be required to have new, uniform labels to help consumers make wise decisions about sun protection.
Regulations that FDA finalized in May list the active ingredients that can be used in over-the-counter (OTC) sunscreen products, as well as requirements for their labeling and testing.
Highlights of the new regulations (referred to as a "final monograph") include:
Also, under the new regulations manufacturers will no longer be allowed to include unsupported, absolute, misleading, or confusing terms such as "sunblock," waterproof," "all-day protection," and "visible and/or infrared light protection" on these products.
In addition to these changes, new cosmetic regulations developed during the sunscreen rule-making require tanning preparations that do not contain a sunscreen ingredient to display the following warning: "Warning--this product does not contain a sunscreen and does not protect against sunburn. Repeated exposure of unprotected skin while tanning may increase the risk of skin aging, skin cancer, and other harmful effects to the skin even if you do not burn."
Sunscreen manufacturers have 24 months to comply with the new requirements. Those who manufacture cosmetic tanning preparations without a sunscreen have 12 months to include the required warning.
Claims about ultraviolet A protection will continue as previously proposed until the agency further evaluates the issue.
A new drug that can effectively treat acute pain, menstrual pain, and osteoarthritis in adults may cause fewer side effects, such as ulcers and bleeding, than some other nonsteroidal anti-inflammatory drugs, or NSAIDs.
When approved in May, the new NSAID, Vioxx (rofecoxib), became the second approved product in a drug class commonly called "Cox-2 inhibitors." The drug's reduced side effects may be due to its ability to inhibit the enzyme cyclo-oxygenase 2 only, rather than cyclo-oxygenase 1 and 2, like most other NSAIDs.
NSAID drugs temporarily relieve pain by blocking the body's production of chemicals believed to be associated with the pain and inflammation of injuries and immune reactions.
In clinical trials, patients treated with 25 to 50 milligrams of Vioxx daily had significantly fewer cases of the type of ulcer called gastroduodenal ulcer than those given daily treatment with 2,400 milligrams of ibuprofen, a commonly used NSAID.
More studies in a larger group of patients are needed to determine if Vioxx actually causes fewer serious gastrointestinal complications than older NSAID products. In the meantime, the labeling for Vioxx will include a warning about the gastrointestinal risks associated with all NSAIDs.
Like other NSAIDs, Vioxx may negatively affect the kidneys, especially at higher doses. But, unlike many other NSAIDs, Vioxx does not interfere with an important part of the blood clotting process called platelet aggregation. Those NSAIDs that interfere with platelet aggregation may increase the risk of bleeding complications in some patients.
Patients should promptly report to their doctors any symptoms of gastrointestinal ulcers or bleeding, skin rash, unexplained weight gain, or swelling.
Vioxx is manufactured by Merck & Co. Inc., Whitehouse Station, N.J.
After some patients died and others suffered liver injuries severe enough to require transplants, FDA issued a public health advisory informing doctors that they should limit the use of the oral antibiotic Trovan (trovafloxacin) and the drug's intravenous form, Trovan-IV (alatrofloxacin). This response to the rare but serious liver injuries is an interim measure until revised labeling for the product can be approved.
In its June advisory, FDA informed physicians that Trovan should be used only in patients who meet all of the following criteria:
FDA also told doctors that:
No reports of liver failure, liver transplant, or death from liver problems were reported in the 7,000 patients studied in premarketing trials for Trovan. In July 1998, after receiving some reports of liver problems associated with the drug, FDA worked with the manufacturer to strengthen the product's labeling. Since then, FDA has continued to get reports of liver toxicity.
The drug's manufacturer, Pfizer Inc., has agreed to limit distribution of Trovan to hospitals and long-term nursing care facilities.
Health-care providers can report Trovan-related adverse reactions to Pfizer at 1-800-438-1985 or to FDA's MedWatch program.
An early warning? ... Testicular cancer may lead to brain damage, seizures, memory loss, and dementia long before the cancer is even detected, say scientists at the Memorial Sloan-Kettering Cancer Center in New York. They report that men with testicular cancer and damage to one of the brain's emotional centers had a type of antibody in their blood long before the cancer was known, suggesting that these antibodies could be used to give patients an early warning of the cancer. Though it accounts for only 1 percent of all cancers, testicular cancer is the most common type in men aged 15 to 34. (New England Journal of Medicine, June 1999)
Cigars have their own danger ... Regular cigar smokers, independent of other risk factors, are at a higher risk for coronary heart disease, chronic obstructive pulmonary disease, and cancers of the mouth, throat or lung, says a study supported by the National Cancer Institute. Researchers at Kaiser Permanente analyzed the medical histories of more than 17,000 men who reported never having smoked cigarettes, and who were not currently pipe smokers. Those who smoked cigars and those who did not were followed from 1971 through the end of 1995 for a first hospitalization or death from a major cardiovascular disease or COPD, and through the end of 1996 for a diagnosis of cancer. The study is the most definitive research yet to link cigar smoking with increased risk of serious illness. (New England Journal of Medicine, June 1999)
Health professionals can report serious adverse reactions or other product problems to FDA's MedWatch program by:
Call the 800 number or visit the Website for forms or for further assistance.
FDA encourages consumers to report through their doctors, but if they prefer, they may submit the MedWatch form themselves.
In a recent three-month period, diabetes treatment saw four important changes: FDA approved three medical products--two new drugs and a unique device--while a third drug underwent labeling changes to reflect new safety information.
Diabetes affects about 16 million Americans. By compromising the body's ability to produce or respond to insulin, the condition can damage the eyes, kidneys, heart, and circulation.
About 90 percent of diabetics in the United States have Type II diabetes (also referred to as non-insulin dependent, or adult-onset, diabetes), which affects mostly overweight people over 40 and can usually be controlled by diet alone. The other type of diabetes, Type I, occurs mainly in young people and is controlled with diet and daily insulin injections.
Prompted by continuing evidence of serious and sometimes fatal liver injury in patients taking Rezulin (troglitazone), a drug approved to treat Type II diabetes, FDA and the drug's manufacturer are tightening restrictions on the drug's use.
In addition to the tighter restrictions, FDA will now allow patients to take Rezulin with sulfonylureas and metformin (Glucophage) if combined use of these drugs alone does not control their diabetes.
Parke-Davis, Morris Plains, N.J., and FDA announced in June that new labeling will recommend that the drug no longer be used as the sole initial agent for Type II diabetes. The labeling also will state that the drug should be used only in patients whose diabetes is not adequately controlled with other treatments and will recommend more frequent liver function tests in patients taking the medicine.
Under the new recommendation, patients will undergo liver function tests before starting the drug, monthly during the first year of use, and quarterly after the first year. The previous labeling recommended only 10 times in the first year and "periodically" after that.
Parke-Davis also will prepare a patient information sheet that pharmacists can give to patients when Rezulin prescriptions are filled. However, FDA urges patients to consult with their doctors before making any changes in their use of Rezulin.
The labeling changes are based on additional analyses of drug study data and postmarketing surveillance information and draw from the March 1999 recommendations of the FDA Endocrinologic and Metabolic Drugs Advisory Committee.
Any adverse reactions should be reported to FDA's MedWatch system or directly to Parke-Davis.
Two new drugs to treat Type II diabetes have received FDA approval.
Avandia (rosiglitazone) and Actos (pioglitazone) improve the body's ability to use the insulin it naturally produces. The body's resistance to insulin is suspected to be an important underlying cause of Type II diabetes.
Either drug can be used alone or in combination with certain other diabetes drugs. But, while Actos can be used in combination with insulin, Avandia is approved only for patients who are not on insulin.
Avandia and Actos are in the thiazolidinedione class of drugs. This class includes Rezulin (troglitazone), which was recently limited in use following reports of severe liver toxicity and deaths (see accompanying article).
No evidence of liver toxicity was seen in clinical trials of Avandia or Actos. However, because of the liver toxicity problems associated with Rezulin, FDA recommends that patients taking Avandia or Actos undergo liver toxicity tests at the start of therapy, every two months during the first year, and periodically thereafter. Symptoms of liver problems include unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, dark urine, or jaundice (yellowish skin and eyes). Patients experiencing any of these should have a liver toxicity test.
Patients taking Avandia or Actos should follow a careful diet and maintain an appropriate weight.
Avandia is made by SmithKline Beecham, Philadelphia. Actos is made by Takeda Chemical Industries, Ltd., and will be co-promoted in the United States by Takeda Pharmaceuticals America Inc. and Eli Lilly and Co.
Health-care professionals can now get longer-term information about glucose levels in patients with diabetes, thanks to a new, first-of-its-kind medical device.
Approved in June, the prescription Continuous Glucose Monitoring System records tissue glucose levels at five-minute intervals for up to three days. The information can then be downloaded to a computer for review by a health professional.
The device measures tissue glucose with a sensor inserted under the skin at the abdomen. A wire connects the sensor to a monitor about the size of a pager, worn externally, which collects glucose data in its memory. After wearing the device for up to 72 hours, the patient throws the sensor away and brings the monitor to the doctor's office.
The monitoring system is intended for one-time or occasional testing. It doesn't replace the standard finger-prick test that diabetics currently use several times a day, but instead supplements it by helping to identify trends in glucose levels, which may fluctuate widely throughout the day. Based on this information, a doctor may decide to adjust a patient's therapy.
FDA approved the monitoring system based on a study at four U.S. medical centers involving more than 7,000 glucose readings in 62 diabetic adults. The device was approved based on experience in patients with Type I diabetes. As a condition of approval, FDA is requiring the manufacturer, Minimed Inc., Sylmar, Calif., to conduct postmarketing studies of the drug's safety and effectiveness in treating other types of diabetes and in children and non-Caucasians.
To order single copies, write to FDA, Rockville, MD 20857. To order 2 to 50 copies, write to FDA, HFI-40, at the same address, or fax your order to 301-827-5308. Include the publication number.
Correction: On page 10 of the article "Breast Cancer: Better Treatments Save More Lives" in the July-August FDA Consumer, an incorrect number was listed for obtaining more information about the Cancer Liaison Program. The correct number is 301-827-4460.
The fall of Reye syndrome ... The number of Reye syndrome cases, a serious disorder that can lead to long-term brain disorders or death, has fallen from 555 in 1980 to fewer than 37 cases each year since 1987, according to a recent report from the national Centers for Disease Control and Prevention. Researchers credit a word-of-mouth campaign spread to parents and doctors, cautioning them not to give aspirin to children who have chickenpox or influenza-like illnesses. In 1982, the U.S. surgeon general warned that using aspirin to treat viral infections could lead to Reye syndrome, and in 1986, FDA required warning labels on all aspirin products. Since then, acetaminophen has replaced aspirin in most medications for fever and aches in children. (New England Journal of Medicine, May 1999)
Toning up is tops for teens ... Teenagers wanting to lose weight and avoid eating disorders should exercise rather than diet, say researchers at the University of Melbourne, Australia. Of 2,000 male and female students 14 and 15 years old studied over three years, those who dieted moderately were five times more at risk for developing eating disorders than those who did not diet. Female adolescents who dieted heavily were 18 times more likely to develop eating disorders. (British Medical Journal, March 1999)
Thigh creams no good for downsizing ... Women who used thigh-reducing creams for six weeks did not slim down their thighs, report researchers at the University of North Carolina at Chapel Hill. To make sure the results weren't biased, the women applied thigh-reducing creams to one thigh and common moisturizing creams to the other, and the circumference of the women's thighs was measured at the beginning and end of the study. (The American College of Sports Medicine)
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