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Safe Medications During Pregnancy: Understanding the Risks

Mark Silber

Last updated: October 26, 2016 3:55 pm

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Finding safe medications during pregnancy is a major concern for any mother-to-be. Pregnancy and drugs can be a dangerous mix: many medicines bring with them a potentially increased risk of causing birth defects.

Any medication taken during pregnancy can affect a developing fetus, at times with tragic results. During pregnancy, care should be taken to check with a doctor before taking any medications.

Certain antiseizure medications — especially those containing valproate, sold as Depacon, Depakote, and Depakote ER, among others — can also increase the risk of birth defects, especially neural tube defects such as spina bifida. Other birth defects are also of concern with antiepileptics, such as cleft palate, skeletal abnormalities, and congenital heart and urinary tract defects. 1

FDA Warnings on Use of Zoloft and Paxil by Pregnant Women

The antidepressants Zoloft and Paxil are two medications that may be risky for a pregnant woman to take. These drugs are selective serotonin reuptake inhibitors (SSRIs), a class of antidepressants that are believed to increase levels of serotonin in the brain.

In 2006, the FDA announced that a study had found that children born to mothers who used SSRIs during pregnancy had a six-fold increase in the incidence of persistent pulmonary hypertension of the newborn (PPHN). 2 PPHN can be a deeply debilitating heart and lung condition that causes a newborn’s circulatory system not to develop properly. This condition can lead to dangerously low oxygen levels in the blood and high blood pressure because normal circulation fails to develop. 3

Babies born with this condition may require supplemental oxygen delivered by a mask or oxygen hood, inserting an endotracheal tube into the windpipe, medications, and mechanical breathing. Babies suffering from PPHN that do not respond to other treatment may even need to be connected to an artificial external lung that delivers oxygen while removing carbon dioxide from the bloodstream. 4

Morning Sickness Medications, Birth Defects and Pregnancy Care

Morning sickness refers to a type of nausea experienced by pregnant women, particularly in the early stages of pregnancy. 5 The medication ondansetron, an antiemetic marketed under brand names such as Zofran and Zuplenz — is not FDA-approved for the treatment of morning sickness.

However, as with many medicines, doctors can and do sometimes prescribe these medications “off-label” to counter the effects of morning sickness.

Important for women who are or believe they may be pregnant is that studies have found that ondansetron can potentially increase the risk of some congenital birth defects. One study found that placental transfer — that is, transmission from the mother to the fetus — may occur in the first trimester in the womb. 6

Another study showed that the babies of mothers who took ondansetron in the first trimester had more than double the risk of suffering from cleft palate, a congenital split in the roof of the mouth. 7

Children born with cleft palate may suffer from a range of problems involving speech or eating. They are also prone to ear infections and hearing problems. 8 Children born with this congenital birth defect typically require one or more surgeries as well as additional medical therapies.

Pregnancy and Drugs: What to Do If You May Have Been Harmed

The manufacturers of Zoloft, Paxil, Zofran and Zuplenz are currently the target of lawsuits by people who believe they and their children have been injured by these drugs. For more information on these legal actions and to determine whether you should consider seeking a legal remedy, visit:

Opioids and Pregnancy—A Dangerous Combination

The overuse and misuse of narcotic pain relievers has been big news lately, with some leading researchers questioning whether the powerful medications are being prescribed appropriately. Now comes another study that brings this question to the forefront. Researchers from Harvard Medical School reported in the May issue of Obstetrics and Gynecology that one in five pregnant women receiving Medicaid filled a prescription for an opioid, up to 41 percent of women in some states.

Opioid use in pregnancy has numerous risks to both the fetus and the mother. Babies born to mothers who used these medications have a higher risk of brain, spine, and spinal cord birth defects, heart defects, and a condition called gastroschisis, in which the intestine sticks out of the abdominal wall. 9 10 11

In addition, infants born to women who are addicted to the drugs or have been using them over a long period of time are born addicted themselves. That means they have to go through a painful and potentially dangerous withdrawal period. The study’s authors evaluated a database of 1.1 million women in 46 states and Washington, DC who were covered by Medicaid and gave birth to live babies between 2000 and 2007. Then they counted those who filled prescriptions for opioid pain relievers, including hydrocodone, codeine, oxycodone, morphine, and fentanyl, during their pregnancy.

Filling Prescriptions During Pregnancy

Between 2000 and 2007, the percentage of pregnant women filling an opioid prescription increased 23 percent, from 18.5 percent in 2000 to 22.8 percent in 2007. The rates varied depending on the women’s race, with a third of white women filling at least one prescription compared to 19.1 percent of blacks and 13.4 percent of Hispanics. About half the women were prescribed opioids for abdominal pain, about a third for lower back pain, and about 20 percent for headaches, including migraines. The most commonly used opioids were codeine and hydrocodone.

The findings, the authors concluded, show that pregnant women are not immune to the current epidemic of prescription opioid use in the general population. Given the risks of birth defects and infant withdrawal, they noted, “This is a significant public health concern.” A similar study of opioid use in pregnant women in a commercial health insurance database found 14.4 percent filled such prescriptions during their pregnancy.

Nearly all women use at least one medication—over-the-counter or prescription—during their pregnancy. Unfortunately, we have little data on the safety of most medications during pregnancy. 12 However, studies do find that acetaminophen (Tylenol), aspirin, and non-steroidal anti-inflammatories like Motrin are relatively safe depending on the stage of pregnancy, the woman’s medical and medication history, and the dosage. 13

The most important thing, however, is to talk to your doctor or midwife before taking any medication – even an aspirin.

  1. http://www.mayoclinic.org/healthy-lifestyle/pregnancy-week-by-week/in-depth/pregnancy/art-20048417http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018723s054,019680s041lbl.pdf 

  2. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm126522.htm 

  3. http://www.nationwidechildrens.org/persistent-pulmonary-hypertension-of-the-newborn  

  4. http://www.crh.org/services/lung-institute/pulmonary-hypertension.aspx 

  5. http://www.mayoclinic.org/diseases-conditions/morning-sickness/basics/definition/con-20033445 

  6. Bengt Danielsson et al., “Use of ondansetron during pregnancy and congenital malformations in the infant,” Reproductive Toxicology (2014).
    Shing-Shun N. Siu et al., “Placental Transfer of Ondansetron during Early Human Pregnancy,” Clinical Pharmacokinetics (2006). 

  7. Marlene Anderka et al., “Medications Used to Treat Nausea and Vomiting of Pregnancy and the Risk of Selected Birth Defects,” Birth Defects Research (Part A): Clinical and Molecular Teratology (2012)  

  8. http://www.cdc.gov/ncbddd/birthdefects/cleftlip.html 

  9. Yazdy MM, Mitchell AA, Tinker SC, et al. Periconceptional use of opioids and the risk of neural tube defects. Obstet Gynecol 2013;122:838–44. 

  10. Broussard CS, Rasmussen SA, Reefhuis J, et al. Maternal treatment with opioid analgesics and risk for birth defects. Am J Obstet Gynecol 2011;204:314.e1–11. 

  11. Patrick SW, Schumacher RE, Benneyworth BD, et al. Neonatal abstinence syndrome and associated health care expenditures: United States, 2000–
    2009. JAMA. 2012;307:1934–40.

  12. Thorpe PG1, Gilboa SM, Hernandez-Diaz S, et al. Medications in the first trimester of pregnancy: most common exposures and critical gaps in understanding fetal risk. Pharmacoepidemiol Drug Saf. 2013;22(9):1013-8. 

  13. Babb M, Koren G, Einarson A. Treating pain during pregnancy. Can Fam Physician. 2010;56(1):25,27.