Counseling Adolescents About Pregnancy Options

Each year, more than 1 million persons under 20 years of age become pregnant, according to a statement from the American Academy of Pediatrics (AAP) concerning counseling the adolescent about pregnancy options. The statement, published in the May 1998 issue of Pediatrics, covers the identification of pregnancy in adolescents, communication with the patient and her family, and management.

Physicians should be able to provide adolescent patients who become pregnant with counseling about all of the options available to them. The AAP notes that physicians should not impose their values on the decision-making process that the adolescent has to go through concerning her pregnancy and should be prepared to support the adolescent in her decision, or refer her to a physician who can offer her that support.

The AAP states that most adolescents who are pregnant have the following three options: carrying her pregnancy to delivery and raising the baby; carrying her pregnancy to delivery and placing the baby for adoption; or terminating her pregnancy. Patients should receive counseling about all three options.

The AAP recognizes that the diagnosis of pregnancy is a sensitive and emotional time for the adolescent, her family and her sexual partner. It is important for the physician to ensure continuing help and support, regardless of the adolescent's decision about her pregnancy.

First Combination Estrogen-Progestin Patch

The U.S. Food and Drug Administration has approved the first hormone replacement therapy that delivers a continuous dose of both estrogen and progestin transdermally via a single patch. For menopausal women with an intact uterus, estradiol–norethindrone acetate (Combi-Patch) transdermal system releases the two hormones from the patch's adhesive. The patch only needs to be changed twice a week.

In multicenter, randomized trials of more than 2,500 menopausal women, the combination patch was shown to be effective in relieving vasomotor symptoms, including hot flushes, night sweats and vaginal dryness.

Combined use of estrogen and progestin is contraindicated in women with known or suspected pregnancy, breast cancer or estrogen-dependent neoplasia; undiagnosed abnormal genital bleeding; and active thrombophlebitis, thromboembolic disorders or stroke. Estrogens given without progestin have been reported to increase the risk of endometrial carcinoma in postmenopausal women. The addition of progestin decreases, but does not eliminate, the risk of endometrial cancer that is associated with the use of estrogen.

Statement on Vacuum-Assisted Deliveries

In response to a recent public health advisory issued by the U.S. Food and Drug Administration (FDA) on the need for caution when using vacuum-assisted delivery devices, the American College of Obstetricians and Gynecologists (ACOG) published a statement (Committee Opinion No. 208) recommending the continued use of vacuum-assisted delivery devices if medically indicated in appropriate clinical settings. ACOG further states that physicians who use vacuum-assisted delivery devices should be appropriately trained, familiar with the indications and contraindications for the use of the device and be familiar with its proper application and traction procedure.

The FDA's advisory was in response to reports of 12 deaths and nine serious injuries over a four-year period among newborns delivered with the use of vacuum delivery devices. The advisory urges physicians to use caution when using these devices.

ACOG notes that the FDA advisory may ultimately increase the rate of cesarean sections or the use of forceps by physicians who may be inadequately trained in the proper use of these procedures. Stanley Zinberg, M.D., ACOG's vice president of practice activities, states, “We really need to see more data collected and evaluated to determine the true risk of these injuries and deaths. While no medical procedure is risk-free, vacuum extraction has an extraordinarily low risk for adverse outcomes.” The committee opinion was published in the September 1998 issue of Obstetrics and Gynecology.

Thalidomide for Lesions in Hansen's Disease

Thalidomide (Thalomid) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of erythema nodosum leprosum, a serious inflammatory condition in persons with Hansen's disease (also known as leprosy). In clinical trials, at least 70 to 80 percent of patients with erythema nodosum leprosum responded to thalidomide therapy with improvements in skin lesions.

Because of thalidomide's potential for causing serious birth defects, the FDA has imposed unprecedented restrictions on the distribution of the drug. To prevent fetal exposure to thalidomide, the manufacturer of the drug has developed the System for Thalidomide Education and Prescribing Safety (STEPS) program. The program was designed in conjunction with the FDA, the Centers for Disease Control and Prevention, the Thalidomide Victims Association of Canada, and several public and women's health groups. Only physicians who are registered in the STEPS program may prescribe thalidomide to patients, and patients must comply with mandatory contraceptive measures, patient registration and patient surveys. In addition, prescriptions for women of childbearing age will not be filled without a physician's written report of a negative pregnancy test conducted within 24 hours of starting thalidomide therapy. These women must have repeated pregnancy tests and use two methods of contraception while taking the drug. Men who take the drug will receive warnings about the risk of contraception failure and of the need to use condoms when having intercourse, because it is not known if thalidomide is present in sperm or semen.

First Vaccine to Prevent Rotavirus

The U.S. Food and Drug Administration has approved the first vaccine (Rotashield) for use in the prevention of rotavirus gastroenteritis. Rotashield is a live, oral, tetravalent vaccine that helps to protect against the four serotypes of rotavirus that are responsible for almost all rotavirus disease in infants and young children. The vaccine is indicated for use in infants in a three-dose series at two, four and six months of age. Each single oral dose of the vaccine is approximately 2.5 mL.

In placebo-controlled trials involving 4,329 infants, the relative efficacy of the vaccine in providing protection against all rotaviral gastroenteritis ranged from 49 to 83 percent. The relative efficacy of the vaccine in providing protection against severe rotaviral gastroenteritis ranged from 70 to 95 percent. Use of the vaccine also reduced the need for medical intervention due to rotaviral infection.

Side effects include mild to moderate fever, usually occurring within five days of administration of the first dose of vaccine. Compared with the infants who received placebo, higher rates of irritability, decreased appetite and decreased activity were reported in some infants following the first dose in some trials. Rotashield is contraindicated in infants with persistent diarrhea or vomiting, in those who are known or suspected to be immunocompromised and in infants who are hypersensitive to latex or to any component of the vaccine, including aminoglycoside antibiotics, amphotericin B or monosodium glutamate.

Cardiovascular Screening of Competitive Athletes

The American Heart Association (AHA) has issued an addendum to its scientific statement for health professionals on screening for cardiovascular abnormalities in young athletes participating in organized sports programs in high schools and colleges. The addendum concerns the timing of preparticipation evaluations, and the AHA offers the following amendment to the original statement published in 1996:

“For collegiate athletes, the American Heart Association recommends that a comprehensive personal and family history be obtained and that a physical examination be performed by a qualified examiner in the first year upon entering the institution and before beginning training and competition. In each of the subsequent three to four years, an interim history and a blood pressure measurement should be obtained. Important changes in medical status or abnormalities detected during interim annual histories may constitute evidence that another physical examination and possible further testing should be performed.” The original AHA recommendation for high school students to have preparticipation screening at two-year intervals remains unchanged.

The addendum was published in the June 1998 issue of Circulation. Scientific statements of the AHA can also be found on the AHA Web site at http://www.amhrt.org.

Nicotine Inhalation System for Smoking Cessation

The U.S. Food and Drug Administration has approved a nicotine inhalation system (Nicotrol Inhaler) for the relief of nicotine withdrawal symptoms in persons who are trying to quit smoking. In the new stop-smoking product, nicotine is inhaled through a mouthpiece and absorbed buccally. Ten puffs on the inhaler provide approximately the same amount of nicotine as one puff on an average cigarette. It is recommended for use as part of a comprehensive behavioral smoking cessation program.

One of the goals of the new system is to provide persons who are trying to quit smoking with the comfort of the hand-to-hand smoking ritual. In placebo-controlled clinical trials, the quit rate in persons using the new system for six months was significantly higher than that in persons who received placebo.

Side effects include irritation of the mouth or throat, cough and gastrointestinal upset. These side effects are usually transient. The inhalation system is contraindicated in women who are pregnant or nursing. The risks of nicotine replacement in persons with certain cardiovascular, peripheral vascular and bronchospastic disease, including asthma, should be weighed against the benefits of including nicotine replacement in a smoking cessation program.