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Oxycodone Birth Defects Lawsuit


A new study has found that women who take Oxycodone or during pregnancy are 1.4-times more likely to have a baby with a birth defect. The risk is greatest when Oxycodone is taken just before or during the first 30 weeks of pregnancy.

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.

September 18, 2013 — The American Journal of Obstetrics and Gynecology has published a study linking the use of opioid painkillers to a 2.2-fold increased risk of all birth defects, and a 2.5-fold increased risk of spina bifida. Click here to read more.

September 16, 2013 — The U.S. Food and Drug Administration (FDA) is recommending that physicians should only prescribe long-acting/extended-release painkillers to people who have severe pain and need 24-hour around-the-clock medication to control severe, chronic pain. Click here to read more.

Oxycodone Overview

Oxycodone is one of the most popular, common prescription painkilling medications. Oxycodone is used to treat moderate to severe pain. It belongs to the narcotic, opioid-based painkillers, which also includes morphine. Oxycodone was developed during the late 1930s as an alternative to morphine, which had shown strong addictive potential and side effects. Oxycodone also has a high risk of addiction, and furthermore, it can cause death and severe side effects when combined with alcohol.

The list of medications that contain opioid painkillers is very long. Some of the most popular opioid medications include:

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

Oxycodone and Pregnancy

Because Oxycodone has a long history of use, many women assume that it is safe to use even during pregnancy. Unfortunately, there is a growing amount of scientific evidence lining Oxycodone to a higher risk of severe birth defects.

The FDA classifies Oxycodone as a Pregnancy Category B drug. This means that they claim the medication is generally safe to use during pregnancy, and the risks to a developing baby are low. In reality, however, this risk may be under-estimated. Despite the popularity of opioid painkillers, there have been surprisingly few studies of the risks of using these medications during pregnancy. Even so, previous studies had suggested Oxycodone could increase the risk of having a baby with cleft lip, cleft palate, or heart defects. More studies need to be conducted.

Scientific Studies of Oxycodone During Pregnancy

Every year, 4 million babies are born in the United States. Of these, 3% have a birth defect, and 1% have a heart defect. Birth defects are the leading cause of infant mortality. One of the most common causes of birth defects is the maternal use of medications during pregnancy. Medications pose the greatest risk in the month before pregnancy, and during the first 30 weeks of pregnancy.

The Centers for Disease Control (CDC) funded the following study: “Maternal treatment with opioid analgesics and risk for birth defects,” which was based on information from the National Birth Defects Prevention Study. It involved 17,449 women who had a baby with a birth defect, compared with about 7,000 women who lived in the same regions and gave birth around the same time, but did not have a baby with a birth defect.

The researchers found that 2% of women whose babies had no defect had used a painkiller, compared to 2.6% of the women whose babies did have a birth defect. The most common types of opioid painkillers codeine, hydrocodone, and oxycodone. According to the findings, women whose babies had a heart defect were 1.4-times more likely to have taken opioids during pregnancy. The most common reasons for taking an opioid painkiller was injury, surgery, infection, and chronic disease.

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