Once the U.S. Food and Drug Administration approves a drug, physicians can use their best judgment to prescribe it to their patients—whether or not their patients are similar to those who took part in the clinical trials. Physicians can also prescribe drugs for diseases or conditions other than those for which they were originally tested.
Many drugs commonly prescribed for children and pregnant women have never been specifically tested in these problems. The result of such off-label prescribing is that some children and pregnant women may receive drugs that don’t work for them, or they may receive too much or too little of a potentially useful drug.
In the March NICHD Research Perspectives, NICHD Director Alan E. Guttmacher, M.D., talks with Dr. Perdita Taylor-Zapata and Dr. Zhaoxia Ren, medical officers in the institute’s Obstetric and Pediatric Pharmacology Branch, which supports many projects to ensure the safety and efficacy of pharmaceuticals used for infants, children, and pregnant women.
The March podcast is available at http://www.nichd.nih.gov/about/overview/directors_corner/podcasts/Documents/NICHD_Research_Perspectives_032613.mp3 (MP3 - 13 MB) and the transcript at http://www.nichd.nih.gov/about/overview/directors_corner/podcasts/Pages/transcript_perspectives_032613.aspx.
Previous NICHD Research Perspectives are available at http://www.nichd.nih.gov/researchperspectives.
About the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): The NICHD sponsors research on development, before and after birth; maternal, child, and family health; reproductive biology and population issues; and medical rehabilitation. For more information, visit the Institute’s Web site at http://www.nichd.nih.gov/.