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Pharmacy and Medications

Is Taking Hydrocodone During Pregnancy Safe?



My doctor is 3 1/2 months pregnant and takes hydrocodone. This is how she takes them: there are 10's and she will take 5 or more of a morning at the same time. I don't know how many through out the day. What effect will this have on the baby?



Use of any medicine during pregnancy should follow a careful evaluation of the risks and benefits associated with its use. Abusing drugs during pregnancy clearly puts both mother and child at increased risk of birth defects and other forms of toxicity. The best source of additional information on this topic is likely to be the OB/GYN physician caring for the mother or the local poison control center.

Hydrocodone is an opioid used to treat moderate to severe pain. In the United States hydrocodone is only available in combination with other therapeutic drugs - generally acetaminophen or Ibuprofen. Hydrocodone containing products with 10 mg of hydrocodone are available with acetaminophen 300 mg, 325 mg, 400 mg, 500 mg, 650 mg, 660 mg, or 750 mg, and Ibuprofen 200mg. These combination products are among the most commonly prescribed pain medications in the USA. As such they are readily available for diversion and abuse. In the USA hydrocodone products are Schedule 3 controlled substances.

People who abuse drugs often ignore the acetaminophen and ibuprofen in these combination products, but in overdose they can cause significant toxicity. Improper use of these medicines during pregnancy can also lead to fetal harm. Taking 5 tablets containing 10mg of hydrocodone will also provide between 1500 and 3750 mg of acetaminophen or 1000mg of ibuprofen.

It seems apparent that your main concern is the possibility that large frequent doses of hydrocodone may cause birth defects. However, while the issue of opioid abuse during pregnancy is significant, it is only one of the important issues your questions raise. It turns out that the high doses of acetaminophen in these products may actually present the greatest risk of harm. Ibuprofen is not likely to be become seriously toxic even with very large doses of the hydrocodone/ibuprofen combination product. In order to answer your questions, it is important to consider all three medicines and their potential to cause fetal harm either by causing a birth defect or actual poisoning. I will discuss the possible risks of each of these ingredients in turn.

Hydrocodone crosses the placenta and reaches the fetal circulation. This means that each dose taken by the mother also delivers a dose to the developing fetus. Normal use of opioids to treat pain associated with needed surgery or injury that occurs during pregnancy is relatively safe. Hydrocodone is listed in pregnancy category C for typical brief use for acute pain. This means that available evidence indicates there is a slightly increased, but ill-defined, risk of birth defects when it is used legitimately. Some studies have shown a slightly increased risk of heart abnormalities. Taking large doses for prolonged periods, especially near-term, is considered more risky (pregnancy category D).

The increased risks with larger doses are mainly related to the increased potential for maternal overdose and physical dependence that can occur in both the mother and the baby. Excessive doses can slow breathing in the mother, which may reduce oxygen delivery to the fetus. Reduced oxygen delivery to the fetus can result in a range of problems up to and including brain damage and fetal death.

Physical dependence in the mother usually translates to similar dependence in the baby. Continued opioid use by the mother during pregnancy will generally prevent opioid withdrawal while the baby is in utero. However, a neonate who is physically dependent on opioids will develop symptoms of opioid withdrawal shortly after birth as the baby's regular supply of opioid from the mother stops. Generally, opioid withdrawal is extremely unpleasant, but is not usually life-threatening.

Concern about physical dependence and neonatal opioid withdrawal is not an absolute contraindication to continued opioid use during pregnancy. There is some evidence that opioid-dependent women in methadone maintenance programs produce healthier babies than similar women who continue to abuse intravenous opioids/narcotics they purchase on the street. This finding is likely related to many factors including less risk of infection, reduced exposure to impurities in street drugs, reduced risk of overdose, perhaps less reliance on prostitution as a source of money to buy drugs and importantly, better access to prenatal care.

Since all available hydrocodone products also contain acetaminophen or ibuprofen, it is important to consider the risks associated with normal and excessive doses of these medicines as well. Both readily cross the placenta and are found in the fetal circulation. Acetaminophen and Ibuprofen are both listed in pregnancy category B when taken at normal doses. This means that for normal doses, available evidence indicates that risk of birth defects is very low. Acetaminophen has a long history of use throughout pregnancy for mild pain and fever. Ibuprofen is somewhat more worrisome from the point of view of risk of birth defects and most doctors avoid its use during pregnancy despite its similar pregnancy risk classification.

Doses of 4 grams or more daily on a regular basis can cause dangerous liver toxicity to the mother. Depending on the product your daughter is abusing, she is approaching this dose with her initial daily dose of 5 tablets. Taking even one more tablet puts her in the high risk zone. Fetal acetaminophen toxicity at this dose is also a big concern. The toxic effect of acetaminophen is related to a particular breakdown product that babies cannot make themselves until approximately the twentieth week of pregnancy. Therefore early in pregnancy, liver toxicity will only occur in the mother. Of course, significant liver toxicity is potentially life-threatening to the mother, and the likelihood of a baby surviving when delivered before the 25th week of gestation is poor. After week 20 or so, the fetal risk approaches that of the mother. Continuous high dose use during pregnancy is thought to have been responsible for a fatal kidney disease in one child reported in the literature.

Use of any medicine during pregnancy should follow a careful evaluation of the risks and benefits associated with its use. The best source of this information is likely to be the OB/GYN physician caring for the mother.

It seems clear your daughter has a significant drug abuse problem. Most women want to stop taking potentially harmful drugs when they become pregnant. The inability or unwillingness of a mother to stop abusing drugs once pregnancy is confirmed may be an indicator of addiction. To get help, visit the Find Substance Abuse and Mental Health Treatment page from the Substance Abuse & Mental Health Services Administration.

This response was prepared in part by Jennifer Hendricks, PharmD student at the University of Cincinnati College of Pharmacy.

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Response by:

Robert James Goetz, PharmD, DABAT
Assistant Professor of Pharmacy Practice
College of Medicine
University of Cincinnati