Bendectin as a teratogen

After the lecture in class on teratogens, I got to thinking about a drug that used to be on the market years ago called Bendectin.  It was a drug that was prescribed by physicians in pregnancy cases where the mother had severe nausea and vomiting.  Morning sickness is not uncommon during pregnancy, especially in the first trimester.  However, some women have a problem with sickness that lasts all day long, for several months, and is severe enough that they run the risk of dehydration and malnutrition for the mother and the baby.  Doctors who believed the mother and baby to be at risk for malnutrition and dehydration, considered this to be more cause for alarm than the Bendectin.

Bendectin was manufactured by Merrell National Laboratories, a subdivision of Merrell Dow Pharmacueticals, and had been used by millions of women around the world since 1956.  This drug became a topic of controversy when a highly publicized flamboyant lawyer made a career out of suing case after case, claiming that Bendectin caused birth defects.  The FDA, as well as several other drug evaluation and regulation agencies around the world, found no evidence of Bendectin being a teratogen or being responsible for birth defects.  In fact, when compared to control groups, the control groups showed higher rates or rates equivalent to the Bendectin groups. However, due to the publicity of the controversy, in 1983 Merrell voluntarily pulled Bendectin off the market in the United States.  The drug is still used in some in Europe without any studies showing any terogenetic effect.  http://www.pubmedcentral.nih.gov

In the discussion of whether any pregnant woman should consume anything that has the potential to be harmful to her baby, be it alcohol, cold medicines, or prescription drugs, I would side with caution.  Why take any risk?  However, when prescribed by a physician that believes the risks are higher to both the mother and the child if severe vomiting persists, and cause-and-effect has not been proven regarding Bendectin and birth defects, then this is a situation that I would make an exception.  At the time I was prescribed and took this medication, I was grateful for the opportunity for my child to grow healthily.  Even this drug does not eliminate nausea and vomiting entirely, there was a better chance that enough fluids and nutrition could be retained so that my baby could develop normally.

Deanna Cote’

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~ by dscote on September 7, 2009.

2 Responses to “Bendectin as a teratogen”

  1. It is unfortunate that someone would go to such lengths without any real evidence to make a case. However, I do agree that all things that are ingested during pregnancy need to be approached with extreme caution.
    Rebekah Pinegar

  2. I am personally curious as to how the lawyer, Melvin Belli, was to make his case, and case after case on that note, in the event that no harm was ever done to ANY baby. I find the matter both intriguing and suspicious…

    The following website goes to say that after the FDA announced advocacy concerning Benedictin and its theoretical sequence on birth defects, they later “reexamined” Benedictin, finding the product a “residual uncertainty.” The defense, or ‘re-examination,’ if you will, took into consideration that such results are “impossible to prove that a drug (generally speaking, but in this case, Benedictin) is harmless..”

    http://www.sciencemag.org/cgi/pdf_extract/217/4557/335

    *Note that the drug was tested on a level concerning birth defects, not teratogenic effects entirely.

    Kellie Gibson

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