Simple Febrile Seizures in Infants and Children

The Committee on Quality Improvement, Subcommittee on Febrile Seizures, of the American Academy of Pediatrics (AAP) has developed a practice parameter on the long-term treatment of neurologically healthy infants and children between six months and five years of age who have had one or more simple febrile seizures. A simple febrile seizure is defined by the AAP as a generalized seizure lasting less than 15 minutes and occurring only once in a 24-hour period in a febrile child who has no other neurologic problem. The practice parameter was published in the June 1999 issue of Pediatrics.

The practice parameter evaluates three possible approaches to the treatment of a child with simple febrile seizures. These include continuous anticonvulsant therapy with agents such as phenobarbital, valproic acid, carbamazepine or phenytoin; oral therapy with antipyretic agents or diazepam; or no anticonvulsant therapy. While treatment with anticonvulsants could prevent additional seizures, the AAP says that the drugs often have adverse effects and there is no evidence that they improve children's health. Antipyretics may improve patient comfort, but do not prevent further seizures. The AAP reviewed more than 300 medical journal articles on simple febrile seizures and found no convincing evidence to indicate that treating these seizures will decrease the risk of developing epilepsy later in life.

The AAP subcommittee also found no evidence that simple febrile seizures cause damage or increase children's risk for mental decline. Children who are under 12 months of age at the time of their first seizure have about a 50 percent chance of having a second seizure, and children who are over 12 months of age at the time of their first seizure have about a 30 percent chance of having another seizure.

Based on the risks and benefits of the treatments, neither continuous nor oral anticonvulsant therapy is recommended by the AAP for children with one or more simple febrile seizures. The AAP recognizes that recurrent episodes of febrile seizures can cause anxiety in some parents and their children. Therefore, the AAP recommends that appropriate education and support be provided.

Shortage of Intravenous Penicillin G

The voluntary recall by Marsam Pharmaceuticals of its penicillin products has caused a temporary shortage of penicillin G products in many areas of the United States. In response to the recent shortage of penicillin G products, the U.S. Food and Drug Administration has begun to identify and assist alternative manufacturers of these products. Until penicillin G is available, the existing supplies should be used only in patients for whom alternative antibiotics are not appropriate. For conditions such as congenital syphilis and neurosyphilis, and intrapartum prophylaxis for perinatal group B streptococcal disease, intravenous penicillin G is considered the optimal treatment.

Alternative treatment recommendations can be found at the Centers for Disease Control and Prevention Web site (http://www.cdc.gov/nchstp/dstd/penicillinG.htm) or by calling the following toll-free, fax-back request line: 888-232-3299.

ACIP Guidelines for Meningitis Vaccination

The Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) has modified its guidelines on the use of the polysaccharide meningococcal vaccine to prevent bacterial meningitis. Vaccination is particularly important for college freshmen who live in dormitories, because they are at a modestly increased risk of meningococcal disease relative to other persons their age.

ACIP recommends that persons who provide medical care to freshmen living in dormitories give information about meningococcal disease and the benefits of vaccination to students and their parents. ACIP also recommends that vaccination be provided or made easily available to undergraduate students who wish to reduce their risk of contracting the disease.

The vaccine that is currently available protects against some serogroups of the bacterium Neisseria meningitidis, which is an important cause of bacterial meningitis and sepsis in children and young adults in the United States. A single dose of the vaccine is recommended to decrease the risk of disease caused by N. meningitidis serogroups A, C, Y and W-135. However, vaccination does not completely eliminate the risk of disease because the vaccine does not protect against serogroup B and does not offer 100 percent protection against serogroups C and Y. In 1998 and 1999, serogroups C and Y caused approximately 70 percent of cases of bacterial meningitis among college students.

For more information on meningococcal disease, symptoms and the vaccine, access the CDC Web site (http://www.cdc.gov/ncidod/dbmd/diseaseinfo) or the American College Health Association (ACHA) Web site (http://www.acha.org/), or write the ACHA at P.O. Box 28937, Baltimore, MD 21240-8937.

New Drug Indication for Menotropins

The U.S. Food and Drug Administration (FDA) has recently approved the use of menotropins (Repronex) for injection for the treatment of patients undergoing ovulation induction and patients involved with in vitro fertilization protocols. The FDA approved both subcutaneous and intramuscular administration for these indications. Menotropins is the first human menopausal gonadotropin approved for subcutaneous administration.

With the new indication for menotropins, infertility patients who are treated with human menopausal gonadotropins now have an easier, more convenient alternative to intramuscular injection. Subcutaneous administration allows the patient to self-administer the medication just under the skin, using needles that are nearly 70 percent smaller than intramuscular needles.

Menotropins is the most frequently prescribed human menopausal gonadotropin. The drug contains equal amounts of follicle-stimulating hormone and luteinizing hormone.

In a multicenter trial, menotropins, administered subcutaneously, resulted in a pregnancy rate of 50 percent in a single cycle among female patients who were undergoing in vitro fertilization. Menotropins stimulates the production of eggs in women whose ovaries are unable to produce eggs for functional reasons, rather than for primary ovarian failure. The drug is also used to stimulate the development of multiple follicles as part of an in vitro fertilization program.

Adverse effects associated with menotropins are similar to those associated with other gonadotropins, including the risk of ovarian hyper-stimulation and reactions at the injection site, although the latter are largely mild and self-limited, occurring early in the course of treatment.

FDA Approval of Stent Graft System

The U.S. Food and Drug Administration has recently approved Medtronic's AneuRx Stent Graft System for the treatment of abdominal aortic aneurysm. It is the first new treatment option for abdominal aortic aneurysm in 40 years, offering many patients a minimally invasive alternative to open abdominal surgery.

When using the stent graft, an incision is made in each groin and the stent graft is inserted by a delivery catheter into the femoral artery. It is then guided through the aorta to the site of the aneurysm. Once the stent graft is in place, it expands to fit within the diameter of the aorta, creating a new path for blood flow and reducing the pressure on the aneurysm.

In a prospective, nonrandomized, multicenter trial that included 482 patients, the AneuRx Stent Graft was shown to be as effective as open surgery in the treatment of abdominal aortic aneurysm. The trial also showed that using the stent graft can reduce the rate of major complications associated with surgery by 50 percent. The AneuRx also improved patients' quality of life by reducing the length of hospital stay (from 9.3 to 3.4 days) and the time to ambulation (from 3.6 to 1.4 days).

Potential adverse effects related to endovascular repair, which are usually not as severe as those associated with open surgery, may include vessel dissection and aneurysm rupture related to improper stent graft placement or migration, infection, bleeding, fever or numbness in the legs.

New Drug for Early-Stage Breast Cancer

Epirubicin hydrochloride (Ellence) injection has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of early-stage breast cancer that has spread to the lymph nodes under the arm and that has been surgically treated by removal of the entire known tumor.

Epirubicin interferes with a number of biochemical and biologic functions within cancer cells. It is a member of the anthracycline class of anticancer medications. These drugs are often used in combination with other medications in the treatment of patients with cancer by slowing or halting the progression of cancer in some patients and prolonging the lives of patients in some settings.

FDA approval of epirubicin was based on the findings of two long-term clinical studies of approximately 1,200 patients. The results showed significant increases in the length of time without a recurrence of the disease and in the five-year overall survival rate.

Some of the adverse effects associated with the use of epirubicin include nausea, vomiting, diarrhea, stomatitis and hair loss. The FDA states that before starting treatment with epirubicin, patients should be warned of the risk of irreversible damage to the heart muscle associated with the drug. In women, there is also a slightly increased risk of leukemia related to treatment with epirubicin, according to the FDA. The medication could harm the fetus if used by a pregnant woman, and may cause premature menopause in premenopausal women. Men taking epirubicin should use effective contraceptive methods, because use of the drug can cause chromosomal damage in sperm.