Commonly Prescribed Drugs Known to Cause Birth Defects

Each year in the U.S., around 150,000 babies are born with birth defects, many of which are linked to drug exposure during pregnancy. While some birth defects are genetic or caused by environmental factors, others result from taking certain prescription drugs while pregnant. The U.S. Food and Drug Administration created a classification system to help indicate whether a drug is considered safe for pregnant women, particularly during the first trimester when the developing fetus is most vulnerable.

Some drugs are known to pose an increased risk of birth defects or life-threatening birth defects. Pharmaceutical companies and healthcare providers are responsible for communicating these risks. However, when prescribing safety is ignored or not adequately managed, the results can be devastating. Children exposed to certain drugs in utero may face permanent health issues, including major congenital malformations, neural tube defects like spina bifida, or even multiple myeloma later in life.

Drugs categories include:

• Category A: Studies indicate there is no fetal risk during the first trimester, nor is there any evidence of risk in later trimesters
• Category B: Animal studies have failed to demonstrate fetal risk, and there have been no well-controlled human studies
• Category C: Animal studies have shown fetal risk, but there have been no well-controlled human studies; potential benefits may outweigh potential risks
• Category D: There exists positive evidence of human fetal risk, but potential benefits may outweigh potential risks
• Category X: Fetal abnormalities have been observed in animal or human studies and/or there exists positive evidence of human fetal risk; the risks clearly outweigh potential benefits

When a medication causes fetal harm, parents may be entitled to compensation for their child’s birth defect. An experienced Orlando injury attorney helps parents hold negligent pharmaceutical companies and reckless doctors and pharmacists accountable for the birth injuries they cause.

Teratogenic Drugs and How They Harm a Developing Fetus

A teratogen is any agent that can disturb fetal development and cause birth defects. According to MedicineNet.com, the following are all teratogenic drugs:

• ACE inhibitors: Lotensin (benazepril), Capoten (captopril), Vasotec and Renitec (enalapril), Monopril (fosinopril sodium), Zestril and Prinivil (lisinopril), Zestoretic and Prinzide (lisinopril and hydrochlorothiazide), Accupril (quinapril), and Altace (ramipril)
• Acne medications: Accutane (isotretinoin) and Retin-A (tretinoin topical)
• Androgens (male hormones)
• Antibiotics: Achromycin (tetracycline), Vibramycin (doxycycline), and streptomycin
• Anticonvulsants: Dilatin (phenytoin), Tridione (trimethadione), Paradione (paramethadione), Tegretol (carbamazepine) and valproic acid (sold under the brand names Depakote, Depakene, Depacon, Depakine, Valparin and Stavzor)
  • Antimetabolite/anticancer drugs: methotrexate (sold under the brand names Rheumatrex and Trexall) and aminopterin
  • Diethylstilbestrol (DES), a synthetic form of estrogen
  • Hyperthyroidism drugs: propylthiouracil, carbimazole, and methimazole
  • Lithium, used to treat bipolar disorder
  • Penicillamine (sold under the brand names Ciprimene and Depen), a chelating agent used to treat Wilson’s disease and rheumatoid arthritis
  • Thalomid (thalidomide), approved to treat erythema nodosum leprosum, a complication of leprosy
  • Warfarin, an anticoagulant sold under the brand names Coumadin, Jantoven, and Marfarin

A teratogen substance interferes with the normal development of a fetus, potentially causing birth defects. Teratogenic effects are most damaging during the first trimester, when critical organs and structures begin forming. Prescription medications, over-the-counter drugs, and even illegal drugs can have severe consequences when taken during pregnancy.

ACE inhibitors, for instance, are prescribed to manage high blood pressure but have been associated with fetal kidney damage and other birth defects. Isotretinoin, found in acne medications like Accutane, is widely known to cause birth defects when taken by pregnant women. Anticonvulsants such as valproic acid and carbamazepine are another class of drugs that can lead to neural tube defects, especially if used without the protective benefit of folic acid supplementation.

Common Prescription Drugs Linked to Severe Birth Defects

Various categories of prescription drugs have been linked to adverse effects on a developing fetus. Among them are:

• Albuterol (sold under the brand names Proventil, Ventolin, Volmax, and Vospire), a pregnancy category C drug used to treat asthma and COPD complications
• Diflucan (fluconazole), a pregnancy category D drug used to treat yeast infections
• Dilantin (phenytoin), a pregnancy category D drug used to treat epilepsy
• Topamax (topiramate), a pregnancy category D drug used to treat certain types of seizures in patients with epilepsy
• Selective serotonin reuptake inhibitors (SSRIs) like sertraline (Zoloft) and fluoxetine (Prozac) have been studied for potential links to cardiac malformations and persistent pulmonary hypertension in newborns.

While SSRIs are critical for managing depression, their use during pregnancy must be closely monitored.

Other prescribed drugs that have raised concern include methotrexate, often used to treat Crohn’s disease and autoimmune disorders, and thalidomide. Women taking thalidomide, originally prescribed for morning sickness and now used to treat multiple myeloma, experienced tragic outcomes in the 1950s and 60s, prompting global changes in drug approval and thalidomide education.

Antifungals like fluconazole (Diflucan), anti-anxiety medications such as benzodiazepines, and mood stabilizers including lithium are among other drugs still being prescribed with a potential risk of birth defects.

Common Over-the-Counter and Illicit Drugs That May Cause Harm

It’s not only prescription medications that carry risks. Common over-the-counter pain relievers like ibuprofen and naproxen have shown adverse effects in later trimesters. Decongestants and certain antihistamines, if not properly dosed, may also affect fetal development. Birth control pills used unintentionally in early pregnancy can sometimes contribute to hormonal disruptions during early fetal growth.

Illegal drugs like cocaine, methamphetamine, and heroin are also teratogenic. Their use has been linked to miscarriage, low birth weight, and birth defects. These substances not only jeopardize the pregnancy but also increase the risk of neonatal abstinence syndrome and long-term developmental delays.

Factors That Influence the Risk of Birth Defects

Timing of exposure is a major factor when evaluating the teratogenic potential of a drug. The earlier in the pregnancy the drug is taken—especially during the embryonic period—the higher the likelihood of fetal harm. The dosage, frequency of use, and whether the drug is taken in combination with other drugs can further affect outcomes.

Genetic predispositions, underlying maternal health conditions, and nutritional factors like folic acid deficiency also play a role. Women with epilepsy, depression, or chronic illnesses often face tough choices about continuing necessary medications while minimizing risks to the fetus.

How a Lawyer Can Help You Understand Your Rights

Suppose your child was born with a serious birth defect and you were prescribed drugs during pregnancy. In that case, it’s important to explore whether your doctor or the pharmaceutical companies failed to warn you properly. Cases involving severe birth defects caused by drug exposure are complex and often require expert medical and legal review.

At Wooten, Kimbrough, Damaso & Dennis, we understand how overwhelming this experience can be. Our team has decades of experience handling claims involving pharmaceutical negligence, and we may be able to help you recover damages for medical expenses, long-term care, and emotional distress.

Contact a qualified Orlando personal injury lawyer or call us at (407) 843-7060 today to learn about your legal rights.