Letters to the editor – Noninvasive Treatments for Umbilical Granulomas – Accurate Information on Drug Effects on Pregnancy Is Crucial – Importance of Preconception Counseling

Letters to the editor – Noninvasive Treatments for Umbilical Granulomas – Accurate Information on Drug Effects on Pregnancy Is Crucial – Importance of Preconception Counseling – Letter to the Editor

Noninvasive Treatments for Umbilical Granulomas

TO THE EDITOR: In the article, “Double-Ligature: A Treatment for Pedunculated Umbilical Granulomas in Children,” (1) the authors describe a technique for extirpating umbilical granulomas; however, they seem to ignore the easily reversed root causes of these lesions. Granulomas usually form in reaction to a low-grade, superficial skin infection in periumbilical crevasses and flourish in the moist environment afforded by today’s large “super-absorbent” diapers that often cover up the area. In minor cases (such as the one in the article (1)), regular eversion by the caregivers of the umbilical stump with cotton-tipped swabs (demonstrated in Figure 1 of the article (1)) allows cleansing with soap and water. This practice, combined with exposing the umbilical stump to the air (by rolling back or trimming the diaper top) will often stop low-grade infections and allow the granuloma to necrose in a matter of days. Application of a topical antibiotic cream (such as mupirocin applied three times daily) is another noninvasive adjuvant that treats the root cause of the granuloma and avoids any further procedural intervention.

ERIC WOOLTORTON, M.D.

University of Ottawa

Department of Family Medicine

43 Bruyere St.

Ottawa, Ontario, Canada, K1N 5C8

REFERENCES

(1.) Lotan G, Klin B, Efrati Y. Double-ligature: a treatment for pedunculated umbilical granulomas in children. Am Fam Physician 2002;65:2067-8.

IN REPLY: Thanks to Dr. Wooltorton for a nice and optimistic overview of noninvasive treatments for umbilical granulomas. I would add a resource (1) to his armamentarium that praises the curative effect of common salt on umbilical granuloma. This article (1) states that the high concentration of sodium ion in the area draws water out of the cells and results in shrinkage and necrosis of the wet granulomatous tissue.

However, contrary to Dr. Wooltorton’s impression, we did not ignore the easily reversed root causes of these lesions; we mentioned them in the first two sentences of the abstract and the first part of the discussion of the article. (2) Dr. Wooltorton also implies that our technique is only pertinent for small umbilical granulomas such as in the case we presented in our article. (2) In reality, it is effective for large pedunculated granulomas and avoids a prolonged and usually unsuccessful trial of conservative treatment. In our experience of treating hundreds of umbilical granulomas in children, the conservative treatments described by Dr. Wooltorton are only effective in a limited group of patients. Most parents will find it difficult and unpleasant to evert the umbilical stump with cotton-tipped swabs, expose the umbilical stump to the air, and then wait for the stump to necrose and drop out.

Dr. Wooltorton’s other suggestion of applying topical antibiotic cream daily is a common practice in our clinic; based on the results of this conservative treatment we decide whether to use the silver nitrate (3,4) or the double-ligature for the final treatment. The technique described in our article is simple, effective, and can be performed by most family physicians without fear or harm to the patient. Giving the mother the opportunity to hold the first ligature results in a positive feedback, because she feels like part of the therapeutic process. Her initial fear is quickly replaced by a sensation of gratification. Despite Dr. Wooltorton’s observations, we still consider the double-ligature technique to be an attractive option for the treatment of pedunculated umbilical granulomas in children, when the conservative treatments fail.

BARUCH KLIN, M.D.

Assaf Harofeh Medical Center

Tel Aviv University

Zerifin, Israel 70300

REFERENCES

(1.) Derakhshan MR. Curative effect of common salt on umbilical granuloma. Iran J Med Sci 1998;23:132-3.

(2.) Lotan G, Klin B, Efrati Y. Double-ligature: a treatment for pedunculated umbilical granulomas in children. Am Fam Physician 2002;65:2067-8.

(3.) O’Donnell KA, Glick PL, Caty MG. Pediatric umbilical problems. Pediatr Clin North Am 1998;45:791-9.

(4.) Chamberlain JM, Gorman RL, Young GM. Silver nitrate burns following treatment for umbilical granuloma. Pediatr Emerg Care 1992;8:29-30.

Accurate Information on Drug Effects on Pregnancy Is Crucial

TO THE EDITOR: The article by Dr. Brundage, “Preconception Health Care,” (1) also stresses the importance of postconception counseling because “40 to 50 percent of pregnancies are unintended,” according to the article. Postconception counseling for inadvertent exposure to medications is therefore just as important as preconception counseling.

Drug labeling is one source of information; however, it is usually outdated regarding teratogenic risks. Multiple other sources are available to assist physicians in assessing reproductive toxicities from drug exposures. The online REPRORISK system (available from Micromedex) contains electronic versions of four teratogen information databases: REPROTEXT, REPROTOX, Shepard’s Catalog, (2) and TERIS. (3) These resources are updated and scientifically reviewed and provide a critical evaluation of the literature regarding human and animal pregnancy drug exposures. More than 20 comprehensive multidisciplinary Teratogen Information Services (TIS) are located in the United States and Canada, that provide patient counseling and risk assessments regarding potential teratogenic exposures (www.otispregnancy.org). Many TIS, such as MotherRisk (www.motherisk.org), use genetic counselors who are excellent resources for pre- and postconception counseling. The National Society of Genetic Counselors (www.nsgc.org) also can locate genetic counselors in most geographic regions.

Erroneous information about drug-associated teratogenic risks is prevalent and can result in unwarranted anxiety along with unnecessary health care interventions, including elective termination of wanted pregnancies. (4) Brundage (1) erroneously reports that angiotensin-converting enzyme (ACE) inhibitors and angiotensin-II receptor antagonists are pregnancy risk Category D. In fact, they are pregnancy risk Category C for first trimester and category D for the second- and third-trimester exposures. The package insert states: “When used in pregnancy during the second and third trimesters, ACE inhibitors can cause injury and even death to the developing fetus … Female patients of child-bearing age should be told about the consequences of second- and third-trimester exposure to ACE inhibitors, and they should also be told that these consequences do not appear to have resulted from intrauterine ACE-inhibitor exposure that has been limited to the first trimester.” Although these drugs should be discontinued on confirmation of pregnancy, Table 2 of the article (1) unfortunately reinforces misleading information that can be alarming to a pregnant woman who is inadvertently exposed during the first trimester.

The U.S. Food and Drug Administration (FDA) recognizes that the availability of factual information is imperative to providing good health care for pregnant women. Unfortunately, package inserts for drugs do not always provide up-to-date information regarding risks during pregnancy. For example, recent research (5) provides evidence, not cited in labeling, that the increased risk of congenital anomalies in children of mothers with epilepsy is associated with the use of anticonvulsant drugs in pregnancy, rather than with epilepsy itself. The FDA is working to improve the information contained in the pregnancy section of product labeling and has been proactive in encouraging the collection of more and better data about drug effects during pregnancy (both to mother and fetus) through the use of pregnancy exposure registries. These prospective registries allow real world clinical practice data on risk (or lack of risk) to ultimately benefit patient care. The FDA provides a list of current pregnancy exposure registries at www.fda.gov/womens/ registries/default.htm.

KATHLEEN UHL, M.D.

DIANNE L. KENNEDY, R.PH., M.P.H.

SANDRA L. KWEDER, M.D.

U.S. Food and Drug Administration

Center for Drug Evaluation and Research

Pregnancy Labeling Team

1451 Rockville Pike, HFD-040

Rockville, MD 20852

REFERENCES

(1.) Brundage SC. Preconception health care. Am Fam Physician 2002;65:2507-14.

(2.) Shepard TH. Catalog of teratogenic agents. 10th ed. Baltimore: Johns Hopkins University Press; 2001.

(3.) Friedman JM, Polifka JE. Teratogenic effects of drugs: a resource for clinicians. 2d ed. Baltimore: Johns Hopkins University Press; 2000.

(4.) Koren G, Pastuszak A. Prevention of unnecessary pregnancy terminations by counseling women on drug, chemical, and radiation exposure during the first trimester. Teratology 1990;41:657-61.

(5.) Holmes LB, Harvey EA, Coull BA, Huntington KB, Khoshbin S, Hayes AM, et al. The teratogenicity of anticonvulsant drugs. N Engl J Med 2001;344: 1132-8.

Importance of Preconception Counseling

TO THE EDITOR: We enjoyed reading Dr. Brundage’s thorough presentation of preconception health care in the June 15, 2002 issue of American Family Physician. (1) The article (1) provided an excellent review of the potential areas in which patients may benefit from preconception counseling. However, we believe that family physicians need additional tools to address the challenges they face in transmitting this information to their patients. A “preconception visit” for all women would be ideal, but they rarely occur in the real world. There are many situations in which preconception counseling strategies would be appropriate, such as at the time of a negative pregnancy test, during a well-woman examination, or during a follow-up visit after a miscarriage; unfortunately, these situations have not been thoroughly studied.

One study (2) showed that simply providing information to women and their physicians about preconception risks did not increase effective interventions. Although preconception health care has been shown to be valuable for women with certain medical conditions, such as diabetes and epilepsy, (3,4) the provision of preconception care has not been well studied in low-risk patients.

Medical knowledge is constantly expanding, and there are ever-increasing demands on our time as family physicians. Therefore, we need practical, proven suggestions for providing preconception counseling in the real world, so the information that was so well presented in Dr. Brundage’s article (1) can be effectively passed on to patients.

KAREN MUCHOWSKI, M.D.

Family Physicians Group

100 E. 33rd St.

Suite 100

Vancouver, WA 98663

HEATHER PALADINE, M.D.

Department of Family Medicine

Oregon Health and Science University

3181 SW Sam Jackson Park Blvd.

Portland, OR 97201

REFERENCES

(1.) Brundage, SC. Preconception health care. Am Fam Physician 2002;65:2507-14.

(2.) Jack BW, Culpepper L, Babcock J, Kogan MD, Weismiller D. Addressing preconception risks identified at the time of a negative pregnancy test. A randomized trial. J Fam Pract 1998;47:33-8.

(3.) McElvy SS, Miodovnik M, Rosenn B, Khoury JC, Siddiqi T, Dignan PS, et al. A focused preconceptional and early pregnancy program in women with type 1 diabetes reduces perinatal mortality and malformation rates to general population levels. J Matern Fetal Med 2000;9:14-20.

(4.) Betts T, Fox C. Proactive pre-conception counseling for women with epilepsy–is it effective? Seizure 1999;8:322-7.

IN REPLY: The letter from Dr. Uhl and colleagues from the U.S. Food and Drug Administration provides some valuable Web sites for current electronic databases and an update on the pregnancy risk categorization of angiotensin-converting enzyme (ACE) inhibitors and angiotensin-II receptor antagonists. I applaud their efforts to inform practicing physicians of updated and timely information. User-friendly Web sites are a valuable tool. The most important fact for the practicing physician to remember about antihypertensives is that ACE inhibitors, angiotensin-II receptor antagonists, beta blockers, and thiazide diuretics are in pregnancy risk Category D for a significant portion of pregnancy. This is not an indication for termination of pregnancy, but a warning that if the drug is used in a woman of childbearing age, the woman should be counseled to see her doctor for a medication change as soon as she suspects she could be pregnant.

The letter from Drs. Muchowski and Paladine highlights the need for additional practical tools to help family physicians provide real-time counseling to most patients (who do not come in for preconception counseling appointments). As a practicing physician, the most useful tools for me are a concise checklist of preconception topics to discuss as needed and a patient information handout, both of which were included in my article. (1) A user-friendly Web site is also very useful. Other useful tools include patient history and encounter forms that prompt the physician to discuss particular areas of concern. Electronic mail messages to patients and electronic patient-tracking databases also can be used to enhance the tailoring of the message to meet the specific needs of the individual patient.

STEPHANIE C. BRUNDAGE, M.D., M.P.H.

Director, Appalachia II Public Health District

200 University Ridge

Greenville, S.C. 29601

REFERENCE

(1.) Brundage SC. Preconception health care. Am Fam Physician 2002;65:2507-14.

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