Drugs That Cause 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.

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. 

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.

Learn more about our work with women’s health lawsuits.