Recommendations for Persons Who Took Diet Drugs

The U.S. Department of Health and Human Services (HHS) has issued preliminary recommendations for the medical management of persons who took the diet drugs fenfluramine or dexfenfluramine. The recommendations, published in the November 14, 1997, issue of Morbidity and Mortality Weekly Report, were developed jointly by the U.S. Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health.

Until more complete information is available, the HHS recommends the following measures:

• Anyone who has taken fenfluramine or dexfenfluramine for any period of time, either alone or with another drug or drugs, should have a medical history and physical examination to determine if there are signs or symptoms of heart or lung disease.

• Anyone who has taken these drugs for any period of time, either alone or with another drug or drugs, and has signs or symptoms of heart or lung disease, such as a new heart murmur or shortness of breath, should have an echocardiogram performed.

• An echocardiogram should be strongly considered for any patient who has taken these drugs, either alone or with another drug or drugs—regardless of whether they have signs and symptoms of the heart or lung diseases—before having any invasive procedure for which the American Heart Association recommends antibiotic prophylactic treatment for the prevention of bacterial endocarditis. This will provide an accurate determination of whether or not the person needs the antibiotic treatment.

The withdrawal of fenfluramine and dexfenfluramine from the market was based on initial echocardiographic findings in five surveys indicating that approximately 30 percent of patients who took these drugs had valvular abnormalities, even though most had no symptoms. Studies are underway and others planned to learn more about the clinical significance of these findings, the natural course of the valvular lesion and what factors may make a person susceptible to their development.

These interim recommendations may be updated as new information becomes available. More information can be found on the FDA's Web site (http://www.fda.gov) and on the Web site of the CDC (http://www.cdc.gov).

Kit for Home Measurement of Glycated Hemoglobin

The U.S. Food and Drug Administration has approved a new kit for measuring long-term blood glucose levels. The B-D Easy A_1c kit will enable patients with diabetes to draw blood samples at home for mail-in laboratory measurement of hemoglobin A_1c (HbA_1c). HbA_1c (or glycated hemoglobin) is a blood component recognized as an accurate, valuable indicator of long-term levels of glucose in the blood. At any given time, a person's HbA_1c level corresponds closely with his or her average glucose levels for the previous four to eight weeks. Measuring these levels provides a long-range perspective on how well glucose levels are being controlled.

Use of the kit involves a simple fingerstick procedure to draw two drops of blood, which are then placed on a specially treated test strip. The strip is mailed to the laboratory. According to the manufacturer, test results should be received within seven to 10 days. Both patients and physicians receive the test results. Once enrolled in the program, patients can receive a new test kit every three months. Over time, users can identify trends in the course of their long-term blood glucose levels. Users are encouraged to discuss the significance of their results with their physicians.

Statement on Aspirin Use in Patients with Diabetes

In a position statement published in the November 1997 issue of Diabetes Care, the American Diabetes Association (ADA) recommends the use of aspirin as primary and secondary prevention therapy against myocardial infarction in patients with diabetes mellitus who are at high risk of cardiovascular events. Also included in that issue of Diabetes Care is a review of the studies used by the ADA to form the basis of its position statement.

The ADA recommends the use of aspirin as primary prevention therapy in high-risk patients with type 1 (insulin-dependent) or type 2 (non–insulin-dependent) diabetes mellitus. Risk factors may include the following: a family history of coronary heart disease; cigarette smoking; hypertension; obesity (more than 120 percent desirable weight; body mass index of more than 28 in women and 27 in men); albuminuria; and high lipid levels (total cholesterol level of more than 200 mg per dL [5.15 mmol per L], low-density lipoprotein level of more than 130 mg per dL [3.35 mmol per L], high-density lipoprotein level of less than 40 mg per dL [1.05 mmol per L] and triglyceride level of more than 250 mg per dL [2.82 mmol per L]).

Aspirin is also recommended by the ADA as a secondary prevention therapy for persons with diabetes who have evidence of large vessel disease. This includes patients with a history of myocardial infarction, vascular bypass procedure, stroke or transient ischemic attack, peripheral vascular disease, claudication, and/or angina. For both primary and secondary prevention, the dose of enteric-coated aspirin recommended can range from 81 mg per day to 325 mg per day.

The statement also notes that some persons may not be candidates for aspirin therapy. These include persons with diabetes under 30 years of age without cardiovascular risk factors, and persons with aspirin allergy, bleeding tendency, anticoagulant therapy, recent gastrointestinal bleeding and clinically active hepatic disease.

Hepatitis A Vaccine for Food Handlers

Following the recommendation of the Advisory Committee on Immunization Practices (ACIP), the U.S. Food and Drug Administration (FDA) has added food handlers to the list of persons who should receive hepatitis A vaccine, inactivated. It is hoped that the change will help minimize problems associated with hepatitis A outbreaks in the food service industry.

“When you consider the high costs of evaluation and treatment associated with a hepatitis A outbreak, vaccination, along with proper food handling may be a cost effective way to help reduce the incidence of this disease,” stated Jeffrey P. Davis, M.D., immediate past chair of the ACIP and chief medical officer for communicable diseases, Wisconsin Division of Health. The FDA has also approved the addition of persons with clotting-factor disorders such as hemophilia and other recipients of therapeutic blood products as a group for whom the hepatitis A vaccine is indicated.

Clopidogrel to Reduce Atherosclerotic Events

Clopidogrel bisulfate (Plavix) has been approved by the U.S. Food and Drug Administration for the reduction of atherosclerotic events (myocardial infarction, stroke, vascular deaths) in patients with atherosclerosis documented by recent myocardial infarctions, recent stroke or established peripheral arterial disease.

The approval was based primarily on the results of the Clopidogrel Versus Aspirin in Patients at Risk of Ischemic Events clinical trial, a randomized, double-blind study including 19,185 persons who had suffered a recent atherosclerotic event or had established peripheral arterial disease. According to the manufacturer, clopidogrel is contraindicated in patients with active pathologic bleeding or patients who have shown hypersensitivity to the drug or any component of the drug and should be used with caution in patients with severe liver disease. The most frequent side effects are rash, diarrhea and pruritis.

—VERNA ROSE