The March of Dimes reports that every year in the United States, about 150,000 babies are born with birth defects. Unfortunately, numerous prescription and over-the-counter medications carry a risk of causing fetal harm. As such, the U.S. Food and Drug Administration developed five pregnancy categories that indicate whether a drug is safe for pregnant women and to what extent. These 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
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
Other drugs linked to birth defects include:
- 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
- Zoloft (sertraline) and Prozac (fluoxetine), antidepressants rated pregnancy category C
According to the U.S. Centers for Disease Control and Prevention, 47.9 percent of Americans have used at least one prescription drug during the past month. If your child was born with a birth defect and your doctor prescribed a potentially dangerous medication during your pregnancy, contact a qualified Orlando injury lawyer today to learn about your legal rights.