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There are established connections between some prescription and over-the-counter (OTC) medications and birth defects. If a pregnant woman takes these medications, her child may be born with a birth defect that can impact the child’s quality of life. Families who experienced this situation may be eligible to file a birth defect lawsuit.
Key takeaways about drugs that cause birth defects
- There are multiple medications that pregnant women should avoid to prevent possible birth defects.
- Cleft palate, structural heart defects and spina bifida are some common birth defects.
- Lawsuits against the manufacturers of medications causing birth defects are ongoing.
What drugs have been linked to birth defects?
Several types of drugs have been associated with birth defects. These include drugs prescribed by a doctor and over-the-counter (OTC) medications.
Birth defects are generally caused by either genetic factors or environmental factors or both. Environmental factors include drugs, alcohol or harmful toxins, such as pesticides.
Some of the most common types of drugs that may cause birth defects include:
- Acne medications
- Anti-nausea medications
- Anti-seizure medications
- Benzodiazepines (used for mental health conditions)
- Blood-pressure medications
- Blood thinners
- Mood-disorder medications
Acne medications
Certain medications prescribed to treat severe acne have been associated with birth defects. For example, a single dose of the retinoid Accutane® (isotretinoin) has been linked to birth defects. Given the risk, women should not use Accutane during pregnancy.
Apart from Accutane, isotretinoin is also known by these brand names:
- Absorica
- Amnesteem
- Claravis
- Myorisan
- Zenatane
The FDA has warned about potential birth defects from using isotretinoin during pregnancy.
Anti-nausea medications
Zofran® (ondansetron) is primarily used for nausea after chemotherapy, radiation treatments or surgery. However, some doctors prescribe off-label use of ondansetron for nausea and vomiting during pregnancy. This use is not approved by the FDA.
Some studies have linked ondansetron with birth defects. A 2019 study found a link between ondansetron use in the first trimester and an increased risk of a congenital heart defect known as ventricular septal birth defect. The study authors did note that “more research is needed to define the critical dose at which risk increases substantially.”
Anti-seizure medications
Some anti-seizure medications may increase the risk of birth defects. These medications include:
- Carbamazepine: Known by several brand names, including Carbatrol, Epitol, Equetro and Tegretol, carbamazepine is prescribed to treat certain types of seizures, bipolar disorder and pain disorders., Some studies looking into the drug suggest an increased risk of major birth defects, including spina bifida, cleft lip, or heart defects.
- Phenobarbital: Studies have found phenobarbital exposure may increase the risk of birth defects, such as cleft palate or heart defects.
- Topiramate: Common brand names for topiramate include Topamax and Topiragen. In 2011, the FDA warned about an increased risk of cleft palate in infants born to pregnant women treated with topiramate.
- Valproic acid: Valproic acid is approved to treat epilepsy and bipolar disorder. It is often prescribed for off-label use to treat migraine prophylaxis, neuropathic pain and behavioral disturbances in dementia. Several countries have restricted valproic acid use for pregnant women due to an increased risk of birth defects.
Benzodiazepines
Some of the most common brand names for benzodiazepines include Ativan (lorazepam), Klonopin (clonazepam), Valium (diazepam), Versed (misazolam) and Xanax (alprazolam). Doctors may prescribe benzodiazepines for on-label uses like:
- Agitation
- Amnesia
- Anxiety
- Insomnia
- Seizure disorders
- Spastic disorders
Off-label uses of benzodiazepines include treatment for bipolar disorder and tics.
Most benzodiazepines pose some risk of congenital birth defects if used during pregnancy. In fact, some experts recommend avoiding all benzodiazepines during the first trimester.
Blood pressure medications
Taking blood pressure medications, such as ACE inhibitors, during the second and third trimesters may increase the risk of birth defects. ACE inhibitors can lower the amount of amniotic fluid (fluid that surrounds the baby). This can lead to serious health concerns for a developing baby.
Blood thinners
The blood thinner Coumadin® (warfarin) is not recommended for women who are or may become pregnant. Coumadin has been linked to fatal hemorrhaging in fetuses when the drug passes through the placenta. Additionally, Coumadin has been linked to birth defects in children born to mothers prescribed the blood thinner during pregnancy.
Mood disorder medications
Multiple mood disorder medications have a link to birth defects, including the following:
- Paroxetine: Marketed under the brand names Paxil®, Aropax®, Brisdelle®, Pexeva® and Seroxat®, paroxetine is a type of antidepressant known as a selective serotonin reuptake inhibitor (SSRI). Some studies have reported a potential increased risk of heart defects when used in the first trimester.
- Venlafaxine: Known by the brand name Effexor®, venlafaxine is commonly prescribed for depression and anxiety. A 2012 study reported a potential association between venlafaxine use and an increased risk of birth defects. The researchers did note that more studies are needed to confirm their results.
Do not stop taking a prescribed medication without first consulting with your doctor. Discontinuing a prescribed medication without your doctor's advice can result in injury or death.
Medications linked to birth defects lead to lawsuits
Families are filing lawsuits against drug manufacturers who market medications linked to increased risk of serious and life-threatening birth defects. These birth defect lawsuits aim to hold pharmaceutical companies accountable for their failure to warn doctors and patients about the risk of birth defects posed by certain medications.
The potential compensation from these lawsuits may also help families cover the medical costs associated with certain birth defects.
Contact a birth defect attorney
If you or a loved one had a child born with a birth defect and took medications while pregnant, contact a medical birth defect lawyer by email or at 1.800.768.4026.
Frequently asked questions about medications that cause birth defects
Can drugs cause birth defects?
Yes. Certain prescription drugs and OTC medications have been linked to birth defects and pregnant women should avoid them. Some of these medications are quite common. They include drugs taken for mental health disorders, epilepsy and high blood pressure.
What is a substance that can cause a birth defect?
“Teratogen” is the medical term for a substance that interferes with fetal development. Exposure to a teratogen may cause birth defects or disabilities in children. A teratogen can be anything from a medication to an environmental toxin. Street drugs and alcohol are also considered teratogens and pose harm to a developing fetus.
Our experience fighting for mothers and children
Motley Rice lawyers have fought to hold prescription drug manufacturers responsible for medications that are linked to an increased risk of serious and life-threatening birth defects.
Our law firm is passionate about helping women seek justice for health issues caused by pharmaceutical companies. Many of our birth defect attorneys are mothers themselves. They have held leadership positions in lawsuits alleging that prenatal exposure to prescription medications caused birth defects.
Key takeaways about drugs that cause birth defects
What drugs have been linked to birth defects?
Medications linked to birth defects lead to lawsuits
Frequently asked questions about medications that cause birth defects
Our experience fighting for mothers and children
- Sources
- Boston Children’s Hospital. Birth Defects and Congenital Anomalies
- Cleveland Clinic. Isotretinoin Capsules
- Cleveland Clinic. Ondansetron Solution
- Cleveland Clinic. Teratogens
- Mayo Clinic. Carbamazepine (Oral Route)
- Medical News Today. The Benefits and Risks of Benzodiazepines
- National Library of Medicine. ACE Inhibitors
- National Library of Medicine. Benzodiazepines
- National Library of Medicine. Carbamazepine
- National Library of Medicine. Impact of Early Life Exposure to Antiepileptic Drugs on Neurobehavioral Outcomes Based on Laboratory Animal and Clinical Research
- National Library of Medicine. Ondansetron (Zofran)
- National Library of Medicine. Paroxetine
- National Library of Medicine. The Association Between Reported Venlafaxine Use in Early Pregnancy and Birth Defects
- U.S. Food and Drug Administration. Coumadin Tablets
- U.S. Food and Drug Administration. FDA Drug Safety Communication: Risk of Oral Clefts in Children Born to Mothers Taking Topamax (Topiramate)
- U.S. Food and Drug Administration. Isotretinoin Capsule Information
- U.S. Food and Drug Administration. Ondansetron (marketed as Zofran) Information
- World Health Organization. Valproic Acid (Sodium Valproate)