Life-Sustaining Treatment for Abused Children

The Committee on Child Abuse and Neglect and the Committee on Bioethics of the American Academy of Pediatrics (AAP) have issued a position statement on forgoing life-sustaining medical treatment in children who have been severely abused. Life-sustaining medical treatment encompasses all interventions that may prolong the life of the patient, including cardiopulmonary resuscitation and artificially administered nutrition. The AAP statement appears in the November 2000 issue of Pediatrics.

According to the AAP, the decision to forgo life-sustaining medical treatment for a critically ill child whose injuries were caused by abuse should be made using the same criteria as those used for any critically ill child. This includes the reasonable medical certainty that life-sustaining medical treatment will fail to maintain the child's life or the disproportionate burden of treatment in the face of irremediable and severe brain or other injury.

Physicians who care for a severely abused child on life-sustaining medical treatment must make many difficult decisions. One concern may be how to proceed when the child will likely survive with seriously disabling neurologic deficits or with continued reliance on life-sustaining medical treatment, such as a ventilator. The AAP stresses that physicians should be aware of the legal and ethical issues in caring for children who have been seriously injured as a result of abuse.

Regardless of the cause, nature and extent of a child's injuries, the parents or guardians should be involved, as appropriate, in all aspects of the child's care and treated with respect and consideration of their privacy. If a physician suspects that a parent or guardian is not acting in a child's best interests, it is appropriate to seek further review and consultation in hopes of resolving the conflict. If a conflict of interest arises with a parent or guardian when a decision to forgo life-sustaining medical treatment risks changing the legal charge faced by the alleged abuser, a guardian ad litem for medical decision making should be appointed by the courts.

AAP Statement on Non-School-Based Education

The Committee on Social Health of the American Academy of Pediatrics (AAP) has issued a statement on home-based, hospital-based and other non-school-based instruction of children and adolescents who are medically unable to attend school. This statement is intended to assist in the evaluation and planning for children to receive non-school-based instruction and to return to school at the earliest possible time. The AAP position statement appears in the November 2000 issue of Pediatrics.

According to the AAP, school-aged children and adolescents should receive their education in school in the setting that is most conducive to learning for the individual student. Some children who experience acute illness or injury or chronic medical conditions (e.g., recovery from surgery, trauma, prolonged recuperation from medical illness and mental health conditions) are unable to attend school on a regular basis. For these children, non-school-based education may be required.

When children are unable to attend school because of a medical condition, their school administrator, parents and physician should work together to select the most appropriate type of non-school-based instruction for the child and must ensure that the child is returned to the regular school setting as soon as possible.

The AAP recommends that the following parameters be considered during planning for a program of non-school-based instruction. First, non-school-based instruction should mirror the progress that the child would make in the classroom. Second, the physician should assess whether the child and teacher place each other at medical risk (e.g., contagious disease). Third, a parent or other responsible adult should be available during instruction. Finally, instruction hours and contacts should be based on the health status of the student and on available resources.

Update on Folic Acid Intake in Women of Childbearing Age

The Centers for Disease Control and Prevention (CDC) has issued a report on the folate status in women of childbearing age in the United States. The report, which appears in the October 27, 2000 issue of Morbidity and Mortality Weekly Report (MMWR), states that in 1992, the U.S. Public Health Service recommended that women of childbearing age increase their consumption of folic acid to reduce the incidence of spina bifida and neural tube defects. In 1996, the U.S. Food and Drug Administration mandated that all enriched cereal grain products be fortified with folic acid.

To assess the levels of folic acid in women of childbearing age, the CDC compared the concentrations of serum and red blood cell folate in women who participated in the 1999 National Health and Nutrition Examination Survey (NHANES 1999) with women of childbearing age who participated in the Third National Health and Nutrition Examination Survey (NHANES III, 1988-1994). The findings show substantial increases in folate concentrations among women of childbearing age.

According to the CDC, one of the national health objectives for 2010 is to increase the proportion of pregnancies that are begun with an optimal level of folic acid. This can be accomplished by increasing the median red blood cell folate level to 220 ng per mL (500 nmol per L) among non-pregnant women 15 to 44 years of age. On the basis of the NHANES 1999, this objective has been met.

The CDC recommends that women of childbearing age who are capable of becoming pregnant should consume 0.4 mg of folic acid per day. Taking vitamin supplements that contain folic acid before and during early pregnancy reduces the risk of neural tube defects. Because up to one half of pregnancies are unplanned and neural tube defects often occur before many women are aware that they are pregnant, food fortification is particularly important.

According to the CDC, the increase in blood folate levels among women who participated in the NHANES 1999 is probably the result of the fortification of enriched cereal grain products, although some of the increase might be attributed to educational efforts and an increase in women using vitamin supplements containing folic acid. If all women of childbearing age consumed folic acid daily, the number of pregnancies affected by neural tube defects would decrease by one half. The CDC states that despite the substantial increase in blood folate concentrations that have been documented in women in the United States, full evaluation of the health impact of folic acid fortification on the occurrence of neural tube defects will require additional study.

FDA Primer for Physicians on the Diagnosis and Management of Foodborne Illness

The Center for Food Safety and Applied Nutrition of the U.S. Food and Drug Administration (FDA), in collaboration with the American Medical Association, the Centers for Disease Control and Prevention (CDC) and the U.S. Department of Agriculture, has developed an educational tool on foodborne illness for physicians. “Diagnosis and Management of Foodborne Illness: A Primer for Physicians” is intended to provide physicians with current guidelines for the diagnosis, treatment, reporting and prevention of foodborne illness. The primer also provides physicians with information for patients on the prevention of foodborne illness.

The primer is composed of patient scenarios and clinical vignettes that are used to educate physicians on foodborne illness. The primer also includes information on clinical considerations; tables on foodborne illness with summaries of clinical and diagnostic considerations, laboratory tests and treatment of bacterial, viral, parasitic and noninfectious causes of foodborne illness; current suggested food safety resources and reading lists; and patient education information on the prevention of foodborne illness.

For a free copy of the primer, fax requests to the FDA Center for Food Safety and Applied Nutrition's toll-free fax line at 877-FOOD-FACS (877-366-3322). An electronic version is also available on the CDC Web site at http://www.cdc.gov/mmwr/cme/conted.html.

Fluoxetine for Premenstrual Dysphoric Disorder

The U.S. Food and Drug Administration has approved a new indication for fluoxetine, a selective serotonin reuptake inhibitor (SSRI), for the treatment of premenstrual dysphoric disorder (PMDD). Fluoxetine was previously sold only under the brand name Prozac. It is now marketed as Sarafem for treatment of PMDD.

PMDD causes depression, anxiety, irritability, anger and other symptoms in the two weeks before menses. The severity of symptoms of PMDD interfere with a patient's occupational and social functioning.

According to the January 22, 2001 issue of The Medical Letter, clinical trials of women with PMDD showed that fluoxetine taken in a dosage of 20 to 60 mg per day through six menstrual cycles improved mood symptoms in 53 percent of participants, compared with improvement in 28 percent of those who took placebo. Results of another trial suggest that taking 20 mg per day of fluoxetine only for the two weeks before menses might be as effective as taking it throughout the cycle.

The Medical Letter reports that the most common side effects associated with SSRIs are nausea, headache, nervousness, insomnia, rash, fatigue and sexual dysfunction, including decreased libido and anorgasmia. Prolonged use may lead to weight gain. Fluoxetine also inhibits cytochrome P450 enzymes 2D6 and 3A4 and interacts with many other drugs.

Sarafem and Prozac are both available in 10- and 20-mg capsules, but in different colors and different packaging. According to The Medical Letter, generic fluoxetine is expected to be available sometime in 2001.

Prevention of Early-Onset GBS Disease in Infants

The Centers for Disease Control and Prevention (CDC) has issued a report on the incidence of early-onset group B streptococcus (GBS). This leading cause of neonatal sepsis results in about 2,200 infections each year among U.S. children younger than seven days of age. To improve prevention, the Active Bacterial Core Surveillance/Emerging Infections Program Network reviewed birth histories of infants with early-onset GBS infection. This report, which appears in the September 8, 2000 issue of Morbidity and Mortality Weekly Report (MMWR), summarizes the results of this analysis and indicates that most mothers of infants with early-onset disease did not receive intrapartum antibiotics.

According to the report, two strategies to prevent perinatal GBS disease are recommended: the risk-based and the screening-based approach. In the risk-based approach, women in labor who have risk factors for GBS transmission are offered intrapartum chemoprophylaxis. In the screening-based approach, all pregnant women are tested for GBS carriage at 35 to 37 weeks of gestation. The GBS carriers are then offered intrapartum chemoprophylaxis.

According to the CDC, from 1993 through 1998, the U.S. incidence of GBS disease decreased by 65 percent. In 1998 and 1999, 21 percent of mothers of affected infants received intrapartum antibiotic prophylaxis. Prenatal screening was often not performed at 35 to 37 weeks of gestation, and combined vaginal and rectal swabs were rarely documented. About 70 percent of women who were unscreened and developed a risk factor did not receive intrapartum antibiotics. Many women were unscreened and did not present with risk factors at the time of labor. Therefore, early-onset disease may have been prevented if the screening-based approach had been used.

The CDC reports that increased prevention of perinatal GBS has raised concern about potential adverse consequences of the increased use of intrapartum antibiotics. Penicillin resistance among GBS isolates has not been reported, but resistance to erythromycin and clindamycin has increased, occurring in 15 to 20 percent of early-onset cases for which isolates were available.

Women with a history of severe penicillin allergy should have prenatal screening that includes susceptibility testing of GBS isolates so that an appropriate regimen for intrapartum prophylaxis can be determined. Use of cefazolin should be considered when erythromycin or clindamycin resistance occurs among women with penicillin allergy.

Copies of consensus guidelines for the prevention of early-onset GBS and educational materials for prenatal patients are available online athttp://www.cdc.gov/ncidod/dbmd/ gbs, or by writing to the CDC, Health Communications Activity (GBS information), mailstop A-49, 1600 Clifton Rd., NE, Atlanta, GA 30333. Bulk orders are available from the Public Health Foundation, 1220 L St., NW, Ste. 350, Washington, DC 20005; telephone: 877-252-1200 or e-mail:www.phf.org.

FDA Approves First Treatment for Cervical Dystonia

The U.S. Food and Drug Administration (FDA) has approved botulinum toxin type B (Myobloc) injectable solution for the symptomatic treatment of patients with cervical dystonia to reduce the severity of abnormal head position and associated neck pain. The manufacturer reports that this is the first FDA-approved treatment for cervical dystonia.

Botulinum toxin type B interrupts the cholinergic transmission between the nerve and the affected muscle, causing the treated muscle to relax and reducing neck pain and severity of abnormal head position. The medication is available in three vial sizes of 2,500 units, 5,000 units and 10,000 units, allowing for maximal flexibility in dosing.

The most common adverse effects of botulinum toxin type B are dry mouth, dysphagia, dyspepsia and pain at the injection site. These temporary effects were generally mild to moderate and resolved on their own. A small percentage of patients experienced severe dysphagia and severe dry mouth in clinical trials. Incidence of adverse effects tends to increase with increasing dosages.

The manufacturer recommends using caution when giving botulinum toxin type B to persons with peripheral motor neuropathic diseases (such as amyotrophic lateral sclerosis or motor neuropathy) or neuromuscular junctional disorders (such as myasthenia gravis or Lambert-Eaton syndrome). Patients with neuromuscular disorders may be at increased risk of clinically significant systemic effects including severe dysphagia and respiratory compromise from typical doses.

For full prescribing information and a comprehensive customer support program that provides services to patients and physicians, contact the manufacturer at 888-GO-1-CALL (888-461-2255).

Mitoxantrone for the Treatment of Multiple Sclerosis

The U.S. Food and Drug Administration (FDA) has approved mitoxantrone (Novantrone) for the treatment of patients with advanced or chronic multiple sclerosis. Mitoxantrone was previously approved for the treatment of patients with pain related to advanced hormone-refractory prostate cancer and, in combination with other drugs, in the initial therapy of acute nonlymphocytic leukemia in adults.

Clinical trials of about 200 patients demonstrated that mitoxantrone reduces the number of relapse episodes and decreases the progression of disability in patients with secondary (chronic) progressive, progressive relapsing or worsening relapsing-remitting multiple sclerosis. The FDA states that mitoxantrone has not been approved for the treatment of primary progressive multiple sclerosis.

The most common side effects of treatment with mitoxantrone include nausea, hair thinning, loss of menstrual periods, bladder infections and mouth sores. The FDA warns that some patients who use mitoxantrone may develop serious heart problems. The risk of heart disease increases with the cumulative dose, and patients with multiple sclerosis should ordinarily not receive more than eight to 12 doses over a period of two to three years. Physicians should closely monitor patients receiving mitoxantrone and should advise patients that regular testing of the heart and blood is required to help avoid serious side effects.

For more information on mitoxantrone for the treatment of multiple sclerosis, call the FDA at 888-INFO-FDA (888-463-6332).

ACS Issues Publication on the Prevention and Early Detection of Cancer

The American Cancer Society (ACS) has published a booklet on the prevention and early detection of cancer. “Cancer Prevention & Early Detection: Facts & Figures 2001” provides the most current data on tobacco use, nutrition, physical activity, obesity and cancer screening. The booklet complements the annual ACS publication, “Cancer Facts & Figures,” by providing information on preventable risk factors and screening examinations that affect cancer incidence, mortality and survival.

The ACS booklet lists the following ACS 2015 challenge goals: a 50 percent reduction in overall age-adjusted cancer mortality rates; a 25 percent reduction in overall age-adjusted cancer incidence rates; and a measurable improvement in the quality of life from the time of diagnosis and for the balance of life of all cancer survivors.

The ACS booklet also provides information and statistics on the following topics: adult and youth tobacco use, adult and youth nutrition, adult and youth physical activity, incidence of adult and youth overweight and obesity, comprehensive school health education, sun protection, early detection of breast cancer, early detection of cervical cancer, early detection of colorectal cancer and early detection of prostate cancer.

Copies of the booklet may be obtained from the ACS national media office by calling 212-382-2169. The publication is expected to be available in 2001 on the ACS Web site athttp://www.cancer.org.