Pregnant women taking Topomax have an increased risk of bearing children with birth defects such as a cleft lip or palate, the Food and Drug Administration (FDA) announced today. The agency is now changing the drug’s label warning and pregnancy classification to inform women about the drug’s defects.
Topomax – known as topiramate in its generic form – is prescribed to treat epileptic seizures and prevent migraine headaches. It is also used on an off-label basis to treat weight loss, alcohol dependence and psychiatric illnesses such as bipolar disorder.
Topomax is manufactured by Ortho-McNeil-Janssen, which has headquarters in Raritan, New Jersey.
New data from the North American Antiepileptic Drug Pregnancy Registry show infants exposed to topiramate as a single therapy in the first trimester had a 1.4 percent prevalence of personal injury and oral cleft birth defects.
This is compared to .38 – .55 percent for other antiepileptic drugs. The oral cleft birth defect rate was .07 percent for infants born to mothers without epilespy and who were not treated with other antiepileptic drugs.
The FDA has re-classified Topomax from a Pregnancy Category C to Pregnancy Category D drug, indicating there is positive evidence of human fetal risk based on human data but the potential benefits from use of the drug in pregnant women may be acceptable in certain situations despite its risks.
The FDA is advising doctors to avoid prescribing the defective drug to women of childbearing age because oral clefts occur in the first trimester before many women know they are pregnant. Doctors are advised to seek alternative medications or if that’s not possible, to recommend proper use of birth control.
Weeks after GlaxoSmithKline (Glaxo) agreed to pay a large settlement to resolve claims alleging its Paxil antidepressant caused birth defects, hundreds of families nationwide are coming forward with new claims.
In July, Glaxo agreed to pay more than $1 billion to resolve 800 cases in which women who took Paxil during pregnancy had children with birth defects, including heart defects, head and brain injuries, abdominal complications and Persistent Pulmonary Hypertension of the Newborn. The women were never warned not to take the drug while pregnant.
“GlaxoSmithKline knew that when Paxil was taken during pregnancy it created a risk of birth defects,” said Ronald Gluck, a Boston product liability lawyer at Breakstone, White & Gluck who is handling Paxil cases.
“Yet, they failed to warn of this fact until it was too late for many mothers. It is important for women who were taking Paxil during pregnancy and whose children suffered birth defects to act now.”
Glaxo has set aside $2.4 billion to resolve new claims involving Paxil and its Avandia diabetes drug.
The recent Paxil birth defects settlement followed a Philadelphia case that was tried in fall 2009. In that case, a jury ordered Glaxo to pay $2.5 million in damages to the family of Lyam Kilker, a 3-year-old boy born with a heart defect after his mother took Paxil during pregnancy.
The jury concluded Glaxo, “negligently failed to warn,” the doctor treating the boy’s mother about Paxil’s risks and that the medicine was a, “factual cause” of the child’s heart defect.
Paxil has had a widespread impact on families. Some 600 families are waiting to try Paxil birth defect cases in Pennsylvania. There are at least 500 cases in Texas and California attorneys are gathering cases as well.
Paxil has not been the subject of a product recall, but the Food and Drug Administration required Glaxo to add a warning to the antidepressant’s label in 2005 following studies linking the drug to birth defects. Specifically, the studies found that women who took Paxil during the first three months of pregnancy were one-and-a-half to two times more likely to have a baby with a birth defect than other women.
If you have a child who has suffered a birth defect as a result of Paxil, it is important to obtain legal advice. Contact Breakstone, White & Gluck today toll-free at 800-379-1244 or visit our website. We can advise you on your rights and options.