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There is new evidence that opioid painkillers such as Vicodin increase the risk of having a baby with spina bifida, a heart defect, eye defects, abdominal defects, brain defects, and more. However, most women are still unaware that Vicodin could potentially cause harm to an unborn baby.


January 28, 2013 — FDA panel votes to re-classify Vicodon as a Schedule II drug in an effort to reduce addiction, abuse, overdoses, and other serious injuries. Click here to read more.

Vicodin Overview

Vicodin is an opioid-based painkiller that contains two active drugs:

  • Hydrocodone (a narcotic, opioid analgesic)
  • Acetaminophen (a mild painkiller that is used to intensity the painkilling effects of hydrocodone)

Vicodin and the opioid painkillers are among the most common medications prescribed to treat mild to moderate pain. Even so, its effects during pregnancy are not well understood, and there have been very few studies that have examined the link between Vicodin and birth defects. Many women believe that Vicodin is safe to use during pregnancy and they are unaware that several studies have found that Vicodin increases the risk of many types of birth defects.

The two most common types of opioid painkillers are codeine and oxycodone. Several brands of cough medications also contain opioid painkillers. This popular group of medications includes, but is not limited to the following drugs:

  • Vicodin
  • OxyContin
  • Oxycodone
  • Hydrocodone
  • Codeine
  • Tylenol-3, 4
  • Demerol
  • Percocet
  • Some cough medicines

Vicodin and Pregnancy

If your baby had a birth defect, you are not alone. Between 3-4% of the 4 million babies that are born in the U.S. every year have a birth defect. Around 1% of these birth defects affect the heart. Birth defects are the leading cause of infant mortality. Children with severe birth defects may need surgery or organ transplants early in life, or they may have a severe disability. If your child had a birth defect and you are facing expensive medical bills, you may be entitled to compensation for your child’s medical expenses, pain, suffering, and your lost income if you decide to file a lawsuit for birth defects caused by Vicodin.

Although there is growing scientific evidence linking Vicodin to birth defects, Vicodin remains classified as a “Pregnancy Category C” medication. What this means is that scientific studies of Vicodin in animals have shown adverse effects on a developing fetus, but scientific studies in humans are still inconclusive. A doctor and patient may still determine that the drug’s benefits outweigh the risks.

Unfortunately, the amount of scientific evidence linking Vicodin to severe birth defects is continuing to grow.

Scientific Studies of Vicodin During Pregnancy

The most conclusive evidence linking Vicodin to birth defects was published in The American Journal of Obstetrics and Gynecology in April 2011, titled “Maternal treatment with opioid analgesics and risk for birth defects.” The Centers for Disease Control (CDC) funded the study, and researchers analyzed data gathered from the National Birth Defects Prevention Study on 17,449 women who had a baby with a birth defect between 1997 and 2005. Of these women, 2.6% used an opioid-based painkiller, and 69% used codeine or hydrocodone.

What the researchers found was that women who used opioid painkillers during pregnancy (especially just before pregnancy or during the first trimester) had a higher risk of having a baby with a birth defect.

The types of birth defects associated with painkillers was diverse, including nearly all areas of the body. The study found the risk of heart defects was nearly doubled. It was also the first study to find a link between painkillers and glaucoma, hydrocephaly, and gastroschisis.

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