AAD Responds to Report on Sunscreens

The American Academy of Dermatology (AAD) has challenged the recent report of a study from Memorial Sloan-Kettering Cancer Center suggesting that suncreens do not protect against melanoma. The AAD says in a statement that it is concerned about the health consequences of public confusion about the safety and efficacy of sunscreens.

“The Academy (AAD) challenges the findings in the report in an effort to reassure the American public that not only are sunscreens safe, they are an important part of a total sun protection program that also includes sun avoidance and sun protective clothing,” states Roger Ceillen, M.D., immediate past president of the AAD.

According to the AAD, four of the five studies cited in the report were concluded before 1980; broad-spectrum sunscreens with a sun protection factor 15 or higher were not readily available until 1984. Because there is a period of at least 10 to 20 years from sun exposure to the clinical appearance of melanoma, the AAD notes that sunscreens would have had little impact on the patients studied.

Indoor Molds and Toxic Effects on Children

The American Academy of Pediatrics (AAP) has released a policy statement to educate physicians about toxic molds, a newly recognized problem and potentially deadly threat to the health of infants. The statement, published in the April 1998 issue of Pediatrics, is titled “Toxic Effects of Indoor Mold.” The statement describes molds, their toxic properties and their potential for causing toxic respiratory problems in infants.

The AAP notes that Stachybotrys atra (also known as Stachybotrys chatarum) has been associated with acute pulmonary hemorrhage in young infants. More than 100 cases of pulmonary hemorrhage in infants have been reported in the United State in the past four years. S. atra may be found in homes with major standing water damage from chronic plumbing leaks or flooding. Affected infants can recover if treated early and if the infant is not exposed to the mold again. In the policy statement, the AAP encourages parents to learn how to spot and remove the deadly mold to prevent ill health effects in their children.

The following AAP recommendations appear in the statement:

• Physicians should ask about mold and water damage in the home when they treat infants with idiopathic pulmonary hemorrhage. Parents should be encouraged to eliminate sources of moisture in the home if mold is present. Interim clean-up guidelines are available through the Centers for Disease Control and Prevention, 1600 Clifton Rd., Atlanta, GA 30333.

• Infants with idiopathic pulmonary hemorrhage must not be exposed to environments in which smoking occurs.

• Cases of idiopathic pulmonary hemorrhage and hemosiderosis should be reported to state health departments.

• Infants who die suddenly without a known cause should have an autopsy performed that includes a Prussian blue stain of lung tissue.

Sildenafil in the Treatment of Erectile Dysfunction

The U.S. Food and Drug Administration has approved the oral therapy sildenafil (Viagra) in the treatment of erectile dysfunction. Sildenafil is the first in a new class of medications known as phosphodiesterase type 5 inhibitors that improve blood flow to the penis. Sildenafil is taken about one hour before anticipated sexual activity.

In clinical trials of men with mild, moderate or complete erectile dysfunction (mean age: 55 years), the drug was shown to be effective in approximately seven out of 10 men overall and was effective across patients with erectile dysfunction attributed to diabetes, spinal cord injury or psychologic causes, among others. Most of the study subjects had experienced erectile dysfunction for an average of five years before entering the clinical trials.

Sildenafil was well tolerated. The most common side effects seen in the men in the clinical trials were headache, facial flushing and indigestion. The drug is contraindicated in patients receiving nitrates in any form, including nitroglycerin.

The American Foundation for Urologic Disease (AFUD) has issued a statement regarding the approval of sildenafil for the treatment of erectile dysfunction. AFUD notes that only 5 to 10 percent of men with impotence currently seek treatment, and AFUD hopes that approval of the drug will encourage more men to visit their physicians for consultation. They suggest that men “take this opportunity to openly discuss all symptoms, causes and treatment options with their physicians and have an overall health examination to select the most appropriate course of treatment.”

Pediatric Equipment in Emergency Departments

Guidelines on which pediatric equipment and supplies are essential for emergency departments to have available were published in the January 1998 issue of the Annals of Emergency Medicine. According to the guidelines, “appropriate care for sick and injured pediatric patients cannot be given if emergency departments are not adequately equipped.” The document, “Guidelines for Pediatric Equipment and Supplies for Emergency Departments,” was developed through a consensus process by a national committee of experts from 11 health and medical organizations.

The guidelines recommend that pediatric equipment and supplies be organized separately and be easily retrievable, either in a specific pediatric cart, pack or section in the emergency department. According to the committee, the list represents minimum equipment and supplies and should not reflect what is needed in pediatric tertiary care facilities. The items on the list are considered to be essential by the committee. The guidelines also contain a chart of pediatric resuscitation medications.

Tolterodine Tartrate for Overactive Bladder

A new medication for the treatment of overactive bladder has been approved by the U.S. Food and Drug Administration. Tolterodine tartrate (Detrol), an anticholinergic drug, is the first medication in over 20 years that has been approved for a bladder control problem.

In one clinical trial that included almost 2,000 adult patients with symptoms of overactive bladder, tolterodine (2 mg twice daily) effectively reduced the median number of times patients urinated over a 24-hour period. In three placebo-controlled, 12-week studies with tolterodine (2 mg twice daily), the study subjects showed a significant reduction (15 to 21 percent) in the median number of urinations per 24 hours, compared with baseline (baseline median ranged from 10.4 to 11.0 urinations per 24 hours). Data also showed that patients receiving tolterodine decreased their incontinence episodes by 50 to 56 percent from baseline, although this reduction was not statistically significant, compared with placebo.

Treatment-related side effects include dry mouth, headache, constipation, indigestion and dry eyes. The drug should not be used in patients with urinary retention, gastric retention and uncontrolled narrow-angle glaucoma.

Measles Update

During 1997, 138 confirmed cases of measles were reported to the Centers for Disease Control and Prevention (CDC) by local and state health departments. According to the CDC, that is the lowest number of measles cases ever reported in one year and represents a 55 percent decrease from the previous record low of 309 cases reported in 1995. The data, published in the April 17, 1998, issue of Morbidity and Mortality Weekly Report, suggest that no endemic measles virus is circulating in the United States.

Of the 138 cases, 57 (41 percent) were international importations (persons who were outside the United States within 18 days before the onset of rash). Thirty-six of the 57 cases (63 percent) occurred in visitors traveling to the United States from other countries. The remaining 21 imported cases occurred in U.S. residents who were abroad during the exposure period.

Of the 81 indigenous cases, 17 (21 percent) were linked epidemiologically to international importations. The most number of cases epidemiologically linked to a single imported case was four.

No measles cases were reported in 21 states for 1997, and in 20 states and the District of Columbia, fewer than five cases were reported. Nine states (Arizona, California, Florida, Massachusetts, Minnesota, New York, Pennsylvania, South Dakota and Texas) accounted for 64 percent of total cases and 56 percent of imported cases. The sporadic distribution of measles cases as well as the small number of cases and the lack of a recurrent viral strain suggest that there is no endemic circulation of measles in the United States.

According to the report, there are still groups in the population with low measles immunity. These groups include those with religious or philosophic objection to vaccination, students in grades not required to have two doses of measles vaccine, health care workers and preschool-aged children in areas with low vaccination coverage. The exposure of these groups to an imported case of measles could still result in an outbreak. The report notes that the elimination of measles from other parts of the world would greatly reduce the risk for importation and spread of measles in this country.

Pilocarpine for Patients with Sjögren's Syndrome

Pilocarpine (Salagen) tablets have been approved by the U.S. Food and Drug Administration for the treatment of dry mouth symptoms associated with Sjögren's syndrome. The tablets were first introduced in 1994 to relieve dry mouth symptoms in patients undergoing radiation therapy for cancer of the head and neck. Pilocarpine is a cholinergic agonist that alleviates dry mouth by stimulating the salivary glands to produce more moisture.

Results of two Phase III clinical studies that included 629 patients with Sjögren's syndrome showed that subjects receiving pilocarpine had significant increases in salivary flow and improvement in the overall feeling of dry mouth, as well as improvement in the specific symptoms of dry mouth, including the severity of dry mouth and mouth discomfort, and the ability to speak and swallow food without drinking. The patients receiving pilocarpine were also more often able to decrease the use of saliva substitutes than those receiving placebo. The most common side effects in patients in the trials were sweating, urinary frequency, chills and flushing.

The manufacturer of pilocarpine sponsors a Dry Mouth Helpline (800-644-4811) for health care professionals and patients with either Sjögren's syndrome or head and neck cancer.

Middle Ear Monitor for Home Use

A new instrument is available for home use to check a child's middle ear for fluid when the child has cold symptoms; this test will help parents determine if the child needs to be seen by a physician. The hand-held instrument, called EarCheck Middle Ear Monitor, uses sonar technology to analyze the response of a child's eardrum to a sound stimulus. The process is painless for the child.

The monitor is intended for use in children who are six months of age to young adults. It should not be used in children with ventilation tubes in their ears. Information on the ear monitor can be obtained by calling 888-327-2435.

New Treatment Option for Acute Otitis Externa

The U.S. Food and Drug Administration has approved a new formulation of ciprofloxacin hydrochloride (Cipro). Ciprofloxacin and hydrocortisone otic suspension (Cipro HC OTIC) is indicated in the treatment of acute otitis externa in adults and in children older than one year.

The approval was based on a prospective, randomized, nonblinded multicenter trial conducted at 30 medical centers in the United States. The trial included 728 adults and children two years and older. All of the subjects had a primary diagnosis of acute diffuse bacterial otitis externa of no more than three weeks' duration. A positive clinical response was shown after seven days of therapy in 90 percent of the patients who received the ciprofloxacin and hydrocortisone otic suspension. At 14 to 28 days of follow-up, 98 percent had responded to treatment.

The most common adverse effects were headache and pruritus. The recommended dosage for all patients is three drops of the suspension in the affected ear twice daily for seven days.

Report on Treatment for Schizophrenia

A new evidence-based analysis funded by the Agency for Health Care Policy and Research (AHCPR) and the National Institute of Mental Health (NIMH) indicates that fewer than one half of patients being treated for schizophrenia are receiving appropriate doses of antipsychotic medications or appropriate psychosocial interventions. The five-year study found that the key to improving outcomes for patients is adoption of a comprehensive and individualized strategy—combining proper doses of appropriate medications, patient and family education and support, and, for high-risk patients, assertive community treatment. The study results and the “Schizophrenia Patient Outcomes Research Team (PORT) Treatment Recommendations” were published in the NIMH Schizophrenia Bulletin.

Other findings from the study include the following:

• Younger patients were more likely than older patients to be offered psychotherapy and vocational rehabilitation. Minority patients were more likely than other patients to be receiving higher doses of antipsychotic medications and were less often prescribed an antidepressant when depressed.

• Psychosocial treatments are often prescribed at the point of hospital discharge, but follow-up is low. Failure to offer these treatments for outpatients may be a serious problem in ongoing community-based care.

• Psychosocial treatment varies according to location. Patients in one state may be more likely than those in another state to be prescribed a vocational intervention and are less likely to be prescribed a family intervention or psychotherapy.

Findings and recommendations from the study are available by calling the NIMH at 301-443-4536. Reprints of the study (AHCPR Pub. 98-R036 and 98-R037) are available by calling the AHCPR Publications Clearing-house at 800-358-9295 or by writing the AHCPR Clearinghouse, P.O. Box 8547, Silver Spring, MD 20907. Reprints are also available through the AHCPR's Web site at http://www.ahcpr.gov/.

In response to the findings, the National Alliance for the Mentally Ill (NAMI) is offering the NAMI “Consumer and Family Guide to Schizophrenia Treatment.” The guide is designed to help patients and their families become more skillful partners in treatment decisions. A copy may be ordered by calling the NAMI Helpline at 800-950-6264.