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Vicodin Birth Defects Lawsuit


New research has found that women who take Vicodin or other opioid painkillers during pregnancy (especially during the first trimester) have a higher risk of having a baby with a severe, life-threatening birth defect.

UPDATE: FDA Urges Caution for Painkillers During Pregnancy

January 9, 2015 — The FDA has issued a Safety Communication to announce that a review of a dozen studies has found inconclusive evidence linking the use of common painkillers during pregnancy with birth defects. Click here to read more.

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 a combination of two painkillers: hydrocodone (an opioid-based painkiller) and acetaminophen (a less potent painkiller that increases the effects of hydrocodone). Vicodin is one of the most common medications that is prescribed to relieve mild to moderate pain, but its effects during pregnancy are poorly understood. Even so, many women take Vicodin during pregnancy because they are unaware of the risks this medication might pose to a developing baby.

Opioid analgesics are a group of medications used to treat pain. The two most common types of opioid painkillers are codeine and oxycodone, but small amounts of opioid painkillers may also be found in many types of cough medicine. Opioid painkillers may include, but are not limited to the following medications:

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

Vicodin and Pregnancy

Major birth defects affect around 3% of the 4 million babies born in the United States, and they are the leading cause of infant mortality. Heart defects are among the most common types of birth defects, affecting about 1% of infants. Previous research has already suggested that first-trimester use of an opioid-based painkiller increases the risk of birth defects. Even so, many women assume opioid painkillers are safe to use during pregnancy. There is a lack of data regarding the risks of using these medications during pregnancy, which is why more studies need to be conducted.

Because there is a lack of safety information, Vicodin is categorized as a “Pregnancy Class C” drug. This classification means that Vicodin has been conclusively shown to cause birth defects in animals, but the risks in humans are still unclear. Furthermore, a physician and a patient may still determine that the benefit of using the medication outweighs the risk. Unfortunately, there is growing amount of scientific evidence linking Vicodin to an increased risk of severe birth defects.

Scientific Study of Vicodin During Pregnancy

Researchers found that maternal use of an opioid painkiller either just before or during early pregnancy was associated with a higher risk of birth defects.

In April 2011, the American Journal of Obstetrics and Gynecology published a study called “Maternal treatment with opioid analgesics and risk for birth defects.” The researchers looked at data from the National Birth Defects Prevention Study, gathered between 1997 through 2005, and involved 17,449 women who had a child with a birth defect. Of these women, 2.6% reported using an opioid analgesic during pregnancy (Vicodin, Oxycodone, Codeine). Of the women who used a painkiller, 69% used codeine or hydrocodone. Most of the women used the medications to treat surgical procedures, injuries, infections, and chronic diseases.

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