tetano
Editor, Senior Moderator
The global H1N1 influenza pandemic disproportionately affected pregnant women, drawing attention to the fact that although they need safe and effective medical treatment, they have always been a marginalized study population. Antiviral agents for treating influenza have been available in the United States for more than 10 years and are widely prescribed for pregnant women. Despite the understanding that physiological changes associated with pregnancy (e.g., changes in renal and hepatic function) can markedly alter pharmacokinetics, pharmacokinetic studies have not routinely been conducted in this population. Not only could the lack of these data result in incorrect dosing and ineffective or subtherapeutic treatment for pregnant women, but inadequate dosing could also potentially accelerate the development of drug resistance and negatively affect the general usefulness of antiviral treatments during a pandemic. In the early 1990s, the Food and Drug Administration (FDA) removed restrictions on, and actually began encouraging, the inclusion of women of "child-bearing potential" in clinical studies. We would argue that it is not only permissible but also imperative that pregnant women be judiciously included in research.1,2
Pregnant women are an important study subpopulation; more than 4 million women in the United States, and 131 million women worldwide, give birth annually. A prescription-database study showed that about 64% of pregnant women in the United States are given prescriptions for one or more medications (excluding vitamins and minerals) for chronic medical conditions or for acute problems that arise during pregnancy.3 Despite these medical needs, clinical studies are rarely conducted in pregnant women. Prescribing decisions are therefore generally not evidence based, a failing that results in inadequately treated medical conditions, the exposure of the fetus to drug therapies at doses that may not even confer benefits to the mother, or treatment that carries undefined risks. For example, preliminary evidence that the higher complication rate associated with H1N1 influenza in pregnant women may be due to the use of inadequate doses of oseltamivir has led some researchers to suggest using higher doses in severely ill pregnant women infected with the H1N1 virus.4 In another example, a 2007 study (partially funded by the FDA's Office of Women's Health) suggested that serum levels of amoxicillin that are adequate to prevent anthrax may be unachievable during pregnancy because of altered renal function.5
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http://content.nejm.org/cgi/content/full/362/24/2241
Pregnant women are an important study subpopulation; more than 4 million women in the United States, and 131 million women worldwide, give birth annually. A prescription-database study showed that about 64% of pregnant women in the United States are given prescriptions for one or more medications (excluding vitamins and minerals) for chronic medical conditions or for acute problems that arise during pregnancy.3 Despite these medical needs, clinical studies are rarely conducted in pregnant women. Prescribing decisions are therefore generally not evidence based, a failing that results in inadequately treated medical conditions, the exposure of the fetus to drug therapies at doses that may not even confer benefits to the mother, or treatment that carries undefined risks. For example, preliminary evidence that the higher complication rate associated with H1N1 influenza in pregnant women may be due to the use of inadequate doses of oseltamivir has led some researchers to suggest using higher doses in severely ill pregnant women infected with the H1N1 virus.4 In another example, a 2007 study (partially funded by the FDA's Office of Women's Health) suggested that serum levels of amoxicillin that are adequate to prevent anthrax may be unachievable during pregnancy because of altered renal function.5
....
http://content.nejm.org/cgi/content/full/362/24/2241