Articles Tagged with Topomax

doctor-expectingmother-blog.jpgJanssen Pharmaceuticals, a unit of Johnson & Johnson, has been ordered to pay $11 million to a mother who was prescribed Topomax and gave birth to a son with a cleft lip. It is the second recent multi-million dollar verdict involving Topomax, an anti-epilepsy drug.

In this case, Haley Powell’s lawyers argued Janssen failed to adequately warn her doctors that Topomax use could lead to birth defects, but said the company had long known. The lawyers stated animal studies as far back as the 1990s showed the risks for birth defects. A jury in the Court of Common Pleas in Philadelphia County awarded the verdict on November 18.

In 2007, a year after Powell began taking Topomax, she gave birth to her son Brayden. Now 5 years old, he faces at least five surgeries before age 21 to repair the defects and nasal deformities it has caused, her lawyers said.

There are 134 Topomax lawsuits pending in Philadelphia. Janssen said it will appeal the Powell verdict along with another one from Oct. 30. On that day, a Philadelphia jury awarded April Czimmer $4.2 million for her son’s cleft lip/cleft palate.

About Topomax

  • Topomax, an anti-epilepsy drug, was approved by the U.S. Food and Drug Administration (FDA) in 1996.
  • Topomax is still on the market. It was never recalled and is prescribed under the name Topomax. The generic – Topomirate – has been available since 2009.
  • The FDA has also approved it as a treatment to prevent migraines, but not to take after a migraine has set in.
  • The FDA has not approved it for these uses, but Topomax has been used experimentally by some doctors to treat psychiatric conditions and side effects of medications to treat psychiatric conditions.
  • In 2011, the FDA asked Janssen to update the Topomax drug labeling. The labeling now states, “If you take topiramate during pregnancy, there is a higher risk that your baby will develop a cleft lip and/or cleft palate.” Read the rest here.
  • If you are a woman of a child-bearing age and your doctor prescribes Topomax, thoroughly question them about other options. Also do you own research and visit another doctor. If you take the medication, make sure to use proper birth control and be closely monitored.
  • If your family has suffered a child birth defect as a result of Topomax or other medication, it is important to contact an experienced lawyer as soon as possible. Birth defects may require multiple surgeries over many years. It is important to obtain the right medical treatment as soon as possible.

Related:
J&J’s Janssen Loses $11 Million Jury Verdict Over Topomax, Bloomberg

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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.
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