Letters to the Editor

Accurate Information on Drug Effects on Pregnancy Is Crucial



FREE PREVIEW Log in or buy this issue to read the full article. AAFP members and paid subscribers get free access to all articles. Subscribe now.


FREE PREVIEW Subscribe or buy this issue. AAFP members and paid subscribers get free access to all articles.

Am Fam Physician. 2003 Feb 15;67(4):700-701.

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. Post-conception 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Drug labeling is one source of information; however, it is usually outdated regarding teratogenic risks.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 Brundage1 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 article1 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 research5 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.

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.

Send letters to Kenneth W. Lin, MD, MPH, Associate Deputy Editor for AFP Online, e-mail: afplet@aafp.org, or 11400 Tomahawk Creek Pkwy., Leawood, KS 66211-2680.

Please include your complete address, e-mail address, and telephone number. Letters should be fewer than 400 words and limited to six references, one table or figure, and three authors.

Letters submitted for publication in AFP must not be submitted to any other publication. Possible conflicts of interest must be disclosed at time of submission. Submission of a letter will be construed as granting the American Academy of Family Physicians permission to publish the letter in any of its publications in any form. The editors may edit letters to meet style and space requirements.



Copyright © 2003 by the American Academy of Family Physicians.
This content is owned by the AAFP. A person viewing it online may make one printout of the material and may use that printout only for his or her personal, non-commercial reference. This material may not otherwise be downloaded, copied, printed, stored, transmitted or reproduced in any medium, whether now known or later invented, except as authorized in writing by the AAFP. Contact afpserv@aafp.org for copyright questions and/or permission requests.

Want to use this article elsewhere? Get Permissions


Article Tools

  • Print page
  • Share this page
  • AFP CME Quiz

Information From Industry

Navigate this Article