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Despite Potential Risk of Serious Birth Defects, New Study Finds Poor Adherence to Oral Contraception among Women on Category X Medications

FRANKLIN LAKES, N.J., Oct. 21 /PRNewswire/ -- An important new study finds that despite the potential risk of serious birth defects associated with the use of medications labeled "Category X" by the Food and Drug Administration (FDA), 40 percent of women between the ages of 18 and 44 using a Category X medication along with an oral contraceptive (OC) do not use their OC properly, increasing the likelihood of an unintended pregnancy.  The study, conducted by the Medco Research Institute™, is published in the October issue of the American Journal of Medicine.



"The risk of developmental toxicity and birth defects among women using a Category X medication is important, and what we discovered through this analysis is that women may not be aware of these risks with Category X medications or they may not understand that to be effective, OCs must be taken on a nearly perfect, consistent basis," said Amy Steinkellner, lead author of the study and National Practice Leader for the Medco Women's Health Therapeutic Resource Center® (TRC).  

Some of the more widely used Category X drugs in women of childbearing age include sedatives and sleep aids, skin treatments known as retinoids, and statins to treat high cholesterol.  The FDA warns against the use of Category X medications in women who are, or may become, pregnant because studies have demonstrated fetal abnormalities associated with use of these drugs.  

Because of the risks, women of childbearing age who are taking a Category X medication should consider using contraception, or discuss an alternative therapy with their physician.  Women who choose to use oral contraception -- one of the most convenient and effective forms of contraception -- need to take the medication precisely as directed, every day, at the same time each day, to effectively prevent pregnancy.

Study Details

Using the Medco Health Solutions, Inc. (NYSE: MHS) database, the study analyzed prescription claims and refill data for more than six million women ages 18 to 44 between January 1, 2008 and June 30, 2009.  Six percent (146,758) of these women were taking medications classified as Category X.  Among this group, 18 percent (26,136) were also on an oral contraceptive medication, just slightly more than the 17 percent of OC users in the general childbearing age group.  

Of the Category X medications used, almost all fell into the following four categories: sedatives/hypnotics, antineoplastics, retinoids and statins, with statins being the most commonly taken medication.

More than one in three women on a statin had suboptimal adherence with their oral contraceptive, as did almost half of the women taking the other Category X medications.  The study also found that the more medications a woman took, both Category X and others, the less likely she was to be adherent with oral contraception.

More details about the analysis and its results can be found at

What Women Need to Know

Women on Category X medications are not alone in their confusion about proper use of oral contraceptives.  A recent survey of patients calling the Medco Women's Health Therapeutic Resource Center® found that one of the most frequently asked questions of Medco's Women's Health Specialist Pharmacists is regarding missed doses of oral contraceptives and how that impacts the effectiveness of the drug.  

Steinkellner continued: "It's clear that more education and counseling is needed to ensure that women on Category X medications are aware of the risks, and if they choose to use an oral contraceptive, how important it is to use it vigilantly.  We encourage all women of childbearing age to ask their doctor or their pharmacist specifically about the risk of birth defects any time they are prescribed a new medication."

Risks associated with Category X medications

Birth defects associated with Category X medications can include the following:

  • Fetal growth restrictions, which in severe cases is associated with an increased risk of neonatal morbidity and mortality as well as an increased risk for cerebral palsy;  
  • Minor or major structural deformities such as heart defects, eye defects, craniofacial (cleft palate) and skeletal defects;
  • Functional/behavioral deficits including mental retardation, which may not be recognized until later in life.

The cause of a birth defect is often the result of a complex interaction between the timing of exposure and the dose of a medication, as well as genetic and other environmental factors.  So, while Category X medications increase the risk of these defects, it should be noted that the majority of women who are exposed to those medications have healthy babies.

About Medco Research Institute

Medco Research Institute™ is an evidence-based research organization focused solely on novel research, analytics and new discoveries that close the gap between scientific discovery and medical practice for improved patient outcomes and lower overall healthcare costs. More information about the Medco Research Institute's peer-reviewed research can be found at

About Medco

Medco Health Solutions, Inc. (NYSE: MHS) is pioneering the world's most advanced pharmacy® and its clinical research and innovations are part of Medco making medicine smarter™ for approximately 65 million members.

With more than 20,000 employees dedicated to improving patient health and reducing costs for a wide range of public and private sector clients, and 2009 revenues of nearly $60 billion, Medco ranks 45th on the Fortune 500 list and is named among the world's most innovative, most admired and most trustworthy companies. For more information, go to

This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties that may cause results to differ materially from those set forth in the statements. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the risks and uncertainties that affect our business, particularly those mentioned in the Risk Factors section of the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission.

SOURCE Medco Health Solutions, Inc.
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