It is no secret that pregnant women have difficulty with medications, as many medicines and drugs can have extremely adverse effects on a fetus. Birth defects attorneys remind pregnant women to always check with their OB/GYN before taking any medications.
Because medicines can have such devastating effects on a pregnancy, a pregnant woman’s medicinal treatment is usually quite limited. For pregnant women suffering from epilepsy, that treatment is about to become even more limited.
Topamax, the FDA, and AdverseEvents, Inc.
Months ago, the Mininno Law Office blog posted about the anti-epileptic drug Topamax, which was shown to cause oral malformations, such as cleft lip or cleft palate, in newborns whose mothers took the drug during pregnancy. The FDA recently changed the drug’s classification from Class C, which is a drug that displayed adverse fetal effects during animal testing, to Class D, which is a classification for drugs that display “positive evidence of human fetal risk.” Now, a litany of other anti-epileptic drugs have been added to a list of drugs that are dangerous to fetuses.
Unfortunately, thanks to the competitive nature of Big Pharma, attorneys, consumer protection and/or patient advocacy groups, and private companies are the people releasing information about the dangers these drugs pose when taken during gestation; dangers as told by the FDA’s Adverse Events Reporting System.
AdverseEvents Inc. is a private company that analyzes the FDA’s adverse drug event database for use in the healthcare industry. AdverseEvents Inc. discovered that the following drugs had as many as 25 reports of birth defect related complications.
- Carbatrol/Tegretol – head and facial deformities, spina bifida, and heart defects
- Depacon/Kene/Kote – neural tube defects, craniofacial defects, cardiovascular malformations
- Dilantin – oral/heart malformations, growth/mental retardation, Fetal Hydantoin Syndrome
- Keppra – skeletal problems, slowed growth (before and after birth)
- Klonopin – Oral malformations (cleft lip/palate), limb defects, infant withdrawal
- Lamictal – cleft lip, cleft palate
- Neurontin – spina bifida
- Trileptal – craniofacial defects, miscarriage
- Zonegran – spina bifida, cerebral palsy, cleft lip/palate
None of the above drugs have had classifications changes from the FDA, but for a few, it is only a matter of time.
Birth Defects Attorneys in New Jersey and Philadelphia
If you are a pregnant and currently taking any of the aforementioned anti-epileptic drugs, speak with your doctor as soon as possible about other, safer options. If you are a parent who has recently given birth to a child who suffers from a birth defect that you believe can be attributed to one of the above prescription drugs, contact the Mininno Law Office to speak with birth defects attorneys and discuss your legal rights. You may also call for a free case evaluation and consultation at 856-833-0600 in New Jersey, or 215-567-2380 in Philadelphia.