Experienced Birth Defect Lawyers
Birth defects are complications that occur while the fetus is developing. These complications can lead to physical or mental disabilities, delayed development, and other long-term issues. Sadly, birth defects are the leading cause of death in children during the first year of life. Some birth defects are minor and can be easily treated or cured, while others lead to a lifetime of medical, surgical, and nursing care needs.
There are more than 4,000 known birth defects. Your dangerous drug attorney at Searcy Denney knows that the most common birth defects are heart defects, cleft lip and cleft palate, Down syndrome, and spina bifida. Nearly 150,000 babies are born with birth defects in the United States each year, according to statistics from the March of Dimes.
Over the years, there have been a number of drugs, (both prescription and over-the-counter) that have been found to cause birth defects and other congenital abnormalities and harm to developing fetuses. If you believe your child has suffered birth defects as a result of prescription or over-the-counter drugs, contact one of the Florida birth defect lawyers at our firm immediately.
These drugs include:
- ACE inhibitors (enalapril or captopril)
- Acne medications (such as Accutane, Retin A, and other Vitamin A preparations)
- Antibiotics (such as tetracycline) and Anti-Fungal medications (such as Diflucan)
- Anti-Cancer drugs
- Antidepressants and SSRIs (including Paxil, Prozac, Celexa, Effexor, Lexapro, Pristiq, and Zoloft)
- Anti-epileptic, anti-convulsant, or seizure medications (such as Depakote, Lamotrigine, Lithium, Topamax, Phenytek, Dilantin, Eptoin, carbamazepine, Tegretol, Carbatrol, and phenytoin sodium)
- Anti-inflammatories and NSAIDs (including acetaminophen, aspirin, ibuprofen, Advil, Motrin, Aleve, and naproxen among others)
- Blood thinners (such as Coumadin and warfarin)
- Cholesterol-lowering drugs (including statins)
- Disease-modifying antirheumatic drugs (such as Arava or leflunomide)
- Drugs which reduce folic acid levels (such as methotrexate or aminopterin)
- Hormone drugs (androgens, testosterone products, estrogens, birth control)
- Immune-modulating drugs (such as Thalidomide which has been blamed for nearly 20,000 birth defects around the world before it was withdrawn due to its significant teratogeneticity)
- Sedatives (such as benzodiazepine drugs)
In an effort to provide patients and prescribing physicians with guidance with regard to the level of fetal risk associated with various prescription drugs, the Food & Drug Administration, since 1979, has categorized medications into 5 categories:
Clinical studies in humans have failed to demonstrate a risk to the first during the first trimester of pregnancy and there is no evidence of risk in later stages of pregnancy.
Clinical studies in humans have failed to demonstrate a risk to the fetus and there are no adequate studies in pregnant women or animal studies have shown an adverse effect but human studies failed to show a risk to the first in any trimester.
Animal studies have shown a risk to a developing fetus, but that fetal risk has not been established in human studies or has not been studied; prescribing physicians and pregnant women are cautioned to ingest the drug only if the benefits outweigh the risks to the fetus.
Risks to the fetus have been documented in human studies, such that the drug should only be used if the benefits outweigh the risks to the fetus.
Risks to the fetus have been documented and those risks are so significant that the drugs should not be given to pregnant women.
The Process of Placing Drugs
The FDA requires a great deal of documentation in order for a drug to be included in Category A, such that many drugs are included in Category C due to a lack of extensive pre-marketing testing rather than due to true, documented risks to babies. Other countries, such as Germany and Australia, use a slightly different approach, which is perhaps better than that used by the Food & Drug Administration, especially with regard to the level of proof required before a drug is placed in Category X (or an equivalent category where a particular drug is contraindicated or, in other words, should not be prescribed under any circumstances to women who are pregnant).
The birth defect lawyers at our Florida law firm warn that, in recent years, certain drugs have been re-categorized, such as the popular antidepressant Paxil, in the face of mounting evidence of fetal toxicity. This failure of pharmaceutical manufacturers to thoroughly test drugs for potential impact on the fetus prior to approval of the drugs for sale by the FDA has led to far too many children being born with significant and avoidable birth defects, developmental delays, and a lifetime of personal and financial challenges for these babies and their families. Currently, there is concern about whether other antidepressants which are part of the class of SSRI (selective-serotonin reuptake inhibitor) drugs should join Paxil as a Category D drug, which would discourage the prescription of this medication to most pregnant women. Currently, the other SSRI drugs (including Celexa, Effexor, Lexapro, Pristiq, Prozac, and Zoloft) are included in Category C, but there is growing evidence also linking these depression medications to the same birth defects that have been associated with Paxil: abdominal deformities, omphalocele, autism spectrum disorder, anal atresia, cardiac or heart defects (including coarctation of the aorta, hypoplastic left heart syndrome, patent ductus arteriosus [PDA], septal defects, Epstein’s anomaly of the heart valves, Tetralogy of Fallot [TOF], transposition of the great vessels, pulmonary atresia, pulmonary valve stenosis), cleft lip and cleft palate, clubfoot, craniosynostosis, limb defects, neural tube defects, spina bifida, and PPHN (Persistent Pulmonary Hypertension of the Newborn).
The risks of birth defects associated with use of over-the-counter drugs is particularly troubling, since many consumers believe that there is little to no risk associated with medications for which a prescription is not required. Many popular over-the-counter pain medications (such as ibuprofen, Advil, Motrin, Orudis, Aleve, and naproxen sodium) are included in FDA Category D, with strong caution against use in the first two trimesters due to concerns about causing harm to the developing fetus, and a prohibition on use during the third trimester due to evidence that ingestion of these drugs can lead to delivery complications. Studies have shown that Persistent Pulmonary Hypertension of the Newborn (PPHN), an often-deadly pulmonary condition where the fetal respiratory system is unable to convert into the respiratory system required to sustain a newborn, is commonly caused by ingestion of a number of over-the-counter and prescription NSAIDs (non-steroidal anti-inflammatory drugs) by pregnant women. Your Florida birth defect lawyers at Searcy Denney warn that the use of aspirin during the last three months of pregnancy can also lead to complications during delivery.
- March of Dimes – Birth Defects: What They Are and How They Happen
- U.S. National Library of Medicine and National Institutes of Health (NIH)
Centers for Disease Control and Prevention
- Organization of Teratology Information Specialists (OTIS)
- Study on Prescriptions Written for Category X Drugs for Pregnant Women
- The United Kingdom Epilepsy and Pregnancy Register
- Powerpoint Presentation on Use of Accutane in Pregnancy by OTIS and March of Dimes
- The Australian Registry of Antiepileptic Drugs in Pregnancy
- The International Lamotrigine Registry
- Guideline on the Exposure to Medicinal Products During Pregnancy from
- European Medicines Agency
- About.com – Medication in Pregnancy
- DailyMed – Collection of prescription drug warning labels
- Antiepileptic Drug Pregnancy Registry – Massachusetts General Hospital