In the United States alone, 119 new drug or biologic applications were approved by the Food and Drug Administration (FDA) in 2004.
FREQUENCY AND VARIETY OF
MEDICATION USE AMONG PREGNANT WOMEN
In
the United States alone, 119 new drug or biologic applications were approved by
the Food and Drug Administration (FDA) in 2004. In the same year, an additional
147 approvals were issued by the FDA for new or expanded uses of currently
marketed drugs or biologics (U.S. FDA, 2005). New drugs do not come to market
with clinical trial safety data specifically designed to address questions
related to human preg-nancy. Once a new drug is available for clinical use, or
a previously marketed drug is approved for a new indication, the frequency with
which it is prescribed and the specific medical conditions that it is used to
treat influence the likelihood that women of reproduc-tive age and pregnant
women will use the drug.
However,
numerous studies have demonstrated that pregnant women are commonly using
several medications over the course of gestation. For exam-ple, in a review of
drug utilization studies, Bonati et al.
(1990) identified 13 publications originating from sites in the United States and Europe in which pregnant women
used an average of 4.7 drugs per person with the mean number ranging from 3 to
11. A 1996 survey of records of the French Health Insur-ance Service
demonstrated that in a sample of 1000 women living in southwest France, 99% of
women received a prescription for at least one drug during pregnancy with a
mean of 13.6 medications prescribed per woman (Lacroix et al., 2000). Similarly, a 2004 study conducted across eight
health maintenance orga-nizations in the United States, in which prescription
records for 152 531 pregnant women were reviewed, found that 64% of these women
were prescribed at least one drug other than a vitamin or mineral some-time
during pregnancy. Moreover, 39% of all women in the sample received at least
one prescription during the first trimester. On average, women received 2.7
drug dispensings and 1.7 different chemical entities over the course of
pregnancy (Andrade et al., 2004).
In
addition to the frequent occurrence of prescrip-tion medication use during
pregnancy, recent evidence suggests that over-the-counter medications are used
even more commonly. Using two large case–control data sets, Werler et al. (2005) demonstrated that
acetaminophen, ibuprofen and pseudoephedrine were used by at least 65%, 18% and
15% of pregnant women, respectively. Furthermore, for some over-the-counter
medications, use was reportedly higher during pregnancy than in the period
before conception.
Given
that a substantial proportion of pregnancies occur without prior planning – in
the United States estimates are that as many as 56% of pregnancies are not
planned – women may be inadvertently exposed to medications before pregnancy is
recognized, and this vulnerable period may extend into the first 4–6 weeks or
longer following conception (Forrest, 1994). Thus, unintentional fetal
exposures can occur during part or all of the most critical period in embryonic
development for drug-induced malformations.
In
addition to medication exposures that take place before pregnancy recognition,
many maternal condi-tions, both acute and chronic, may require treatment after
pregnancy is confirmed. A variety of relatively common diseases that occur in
women of reproductive age may necessitate treatment throughout the course of
pregnancy. For example, the prevalence of clinical depression among women in
their reproductive years is estimated to be as high as 8.0%–20.0% (Kessler et al., 1993), asthma 3.7%–8.4% (Kwon,
Belanger and Bracken, 2003), epilepsy
0.4%–1.0% (Yerby, 2000; Holmes, Wyszynski and Lieberman, 2004) and rheumatoid
arthritis and other autoimmune disorders 1.0%–2.0% (Belilos and Carsons, 1998).
For some of these maternal conditions, a decision not to treat (or to under
treat) could lead to events, such as uncontrolled seizure activity or
psychiatric episodes, which could be detrimental to the woman, the pregnancy
and/or the fetus itself (Goldberg and Nissim, 1994; Bracken et al., 2003; Cohen et al., 2006). Thus, the develop-ment of adequate information on
drug safety in preg-nancy involves two equally important objectives: the identification
of potentially harmful exposures that might be avoided or managed and the
establishment of acceptable margins of safety for drugs that offer potential
benefit to women during their pregnancies.
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