New Jersey Drug-Related Birth Injury Lawyers
Approximately one out of every ten birth defects is caused by the use of over-the-counter or prescription drugs during pregnancy. Drugs that cause birth defects are called teratogens. Teratogenetic drugs can interfere with the normal development of a fetus during any stage of a woman’s pregnancy, although the most severe abnormalities often occur when taken between the third and eighth week of pregnancy (when the fetus’ major organ systems are forming).
If your physician prescribed medication during your pregnancy or while you were nursing that you believe harmed your baby, the lawyers at Shebell & Shebell can help. You can be confident that you are placing your trust in one of New Jersey’s top personal injury law firms, with a proven track record in birth defect litigation.
FDA Medication Safety Guidelines
In the United States, the U.S. Food and Drug Administration (FDA) requires significant clinical testing to ensure the safety of drugs. Generally, the FDA does not test drugs on pregnant woman because of the ethical implications to the unborn fetus. However, the FDA does track reports of women who have used certain drugs while pregnant and had children born with birth defects.
The FDA has established five categories to indicate the potential of a drug to cause birth defects if used during pregnancy. The categories are:
- Category A: Controlled studies show no risk or evidence of harm when used during any trimester.
- Category B: Animal studies show no risk, but controlled studies have not been conducted on pregnant women.
- Category C: Animal studies have shown fetal harm, but no controlled studies have been performed on pregnant women. Potential benefits may warrant use of the drug despite potential risks.
- Category D: There is evidence of human fetal risk, but benefits may warrant use of the drug despite risks (for example, to treat a condition that threatens the life of the mother).
- Category X: Studies in animals or pregnant women have demonstrated fetal abnormalities, and the risks outweigh any potential benefits.
- Category N: The FDA has not classified the drug. Examples include aspirin, oxycodone, hydroxyzine, acetaminophen and diazepam.
Despite FDA warnings, doctors may still prescribe drugs that are categorized as unsafe. With newer drugs, there may be insufficient data to determine whether a medication is safe. In some cases, a manufacturer may not adequately disclose the risks.
Drugs Associated With Birth Defects
Many drugs prescribed every day for common conditions are widely known to cause birth defects if taken during pregnancy. Drugs that have been linked to birth defects include:
- Antidepressants: Selective Serotonin Reuptake Inhibitors (SSRIs) are among the most commonly prescribed drugs to treat depression and anxiety. These mood stabilizers have been associated with causing heart conditions, cleft lip and palate, and umbilical hernias (omphalocele) in unborn babies. Common brand names for these drugs include Celexa, Lexapro, Paxil, Prozac, and Zoloft. Serotonin-norepinephrine reuptake inhibitors (SNRIs), such as Effexor, are also known to cause birth defects.
- Antiemetics (anti-nausea medications): Zofran (ondansetron) is a drug that falls under the category of serotonin 5-HT3 receptor antagonist medications. It was developed to treat nausea and vomiting after surgery and chemotherapy. Although never approved by the FDA for the treatment of morning sickness, some doctors have prescribed it “off label” for that purpose. Taking Zofran, especially during the first trimester, has been linked to muscular and skeletal abnormalities, club feet, cleft lip and/or palate, jaundice and heart problems in unborn babies.
- Acne medications: Strong medications used to treat cystic acne, such as Accutane and Retin-A, are very clearly linked to severe birth defects. The patient warnings accompanying Accutane recommend that any woman of childbearing age taking the drug must use reliable contraception. Birth defects linked to these drugs include vision impairment, hearing impairment, facial defects, underdeveloped or missing earlobes, mental retardation and heart problems.
- Anti-seizure medications: Anti-epileptic drugs are usually prescribed to patients suffering from epilepsy. Some may also be prescribed off-label to treat bipolar disorder. Common trade names include Dilantin, Lamictal, Neurontin, Tegretol, Phenobarbital, Trimethadione, Phenytoin, Carbamazepine and Depakote. These medications can greatly increase the risk a child will be born with a heart defect, skeletal malformation, cleft lip and/or palate, or developmental delays that do not present themselves until later in life.
- Birth control: Some birth control pills, such as Yaz and Ortho Evra, have been linked to birth defects.
- Fertility drugs: Clomid, a popular fertility drug, has been linked to very serious birth defects when taken immediately before or during early pregnancy.
- Statins: Use of cholesterol lowering drugs such as Lipitor, Zocor, Pravachol, Crestor, Lescol, Mevacor and Baycol have been associated with severe central nervous system defects and malformed limbs.
- Antibiotics: Certain antibiotics are known to cause birth defects, including Sulfonamides, Chloramphenicol and Streptomycin.
- Anti-thyroids: Use of Methimazole and Propylthiouracil has been associated with choanal atresia, esophageal atresia, aplasia cutis, umbilical cord defects or omphalocele.
Over-The-Counter (OTC) Medications
Studies have shown that the average American believes there is no danger in taking OTC drugs during pregnancy. However, many popular OTC drugs, including pain relievers and acne creams, pose potential risks to a developing fetus. If you are unsure about the safety of an OTC medication during pregnancy, speak to your doctor.
How the Birth Injury Lawyers at Shebell & Shebell Can Help
If your baby was born with a birth defect, you may be asking what happened and who is responsible. Many children with birth defects require expensive surgeries and life-long medical care. If you were prescribed a drug that is known to cause problems in pregnancy, and your doctor failed to warn you of the risks, you may be entitled to compensation to cover these costs. You may also be entitled to damages for lost income, pain and suffering, emotional distress and/or wrongful death of your child. To speak with a lawyer about your case, call us at 866-957-5237 or contact us online.