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Topamax Lawsuit

According to the U.S. Food & Drug Administration, Topamax has been associated with birth defects that occur when parts of the lip or palate improperly fuse together early in the first trimester of pregnancy. The birth defect occurs often before a woman realizes she is expecting. Topamax an anticonvulsant and antiepileptic drug used to treat certain types of seizures in peoples who have epilepsy. Doctors prescribe Topamax off-label to women to help prevent migraine headaches. Additionally, the FDA reports that the defects range from a small notch in the lip to a groove that runs into the roof of the mouth and nose. Cleft palate and cleft lip defects can lead to problems with eating, talking and to frequent ear infections.

Children affected with Topamax caused cleft lip and cleft palate birth defects require surgical intervention to close the lip and palate, which may expose children to risks associated with major surgery.

The North American Antiepileptic Drug (AED) Pregnancy Registry compiled data on Topamax to show an increased risk of oral birth defects such as cleft palate and cleft lip in infants exposed to Topamax, including the drug’s generic versions containing topiramate, in the first trimester. Infants exposed to Topamax had an 1.4 percent rate increase of mouth birth defects, more than any other antiepileptic drug. A study conducted in 2008 and published in the medical journal Neurology, found that women who took Topamax during early pregnancy were approximately 11 times more likely to have a baby born with a cleft lip or cleft palate, and 14 times more likely to have a baby born with a genital defect.

If you or a loved one took Topamax or any of its generic version during the first trimester of pregnancy and had a baby born with an oral birth defect, cleft lip, cleft palate or other fetal development defect, contact Greg Jones Law as you may be entitled to compensation.

Topamax Birth Defects In Babies

The following birth and side effects in infants have been associated with prenatal, first-trimester use of Topamax:

  • Cleft lip
  • Cleft palate
  • Genital defects
  • Fetal and skeletal deformities

Topamax Side Effects in Women

While Topamax has been associated with birth defects in babies, it is also a medication with serious adverse events that can be a health risk to mothers. The following are some side effects in women that have been associated with the use of Topamax:

  • Numbness, burning or tingling in the hands or feet
  • Slowed reactions
  • Speech problems
  • Memory problems
  • Lack of coordination
  • Aggressive behavior
  • Nervousness
  • Depression
  • Headaches
  • Drowsiness
  • Uncontrollable shaking
  • Uncontrollable eye movement
  • Diarrhea
  • Heartburn
  • Swelling of the tongue
  • Hair loss
  • Blurred vision
  • Worsening of seizures
  • Slow heart rate
  • Chest pain
  • Nausea
  • Vomiting
  • Stomach pain
  • Fever
  • Chills

The FDA has raised Topamax’s pregnancy category from C to a more serious category D following the NAAED‘s report, which means there is significant evidence that the drug can harm a human fetus. The new strict label will include information for mothers of the potential dangers and birth defects associated with the use of Topamax during pregnancy. The agency has also asked health care professionals to warn female patients of childbearing age of the drug’s risks to a human fetus. Additionally, Topamax patient medication guide and prescription information will also be updated with the increased warnings. The FDA suggests that women who became pregnant while taking Topamax register with the North American Antiepileptic Drug Pregnancy Registry, as it will help collect further information on health and infant risks associated with this class of drugs.

Topamax comes as an oral tablet and a sprinkle capsule that can be sprinkled on food. The medication is usually taken with or without food twice a day in the morning and evening. A health care professional usually prescribes a lower dosage of Topamax and gradually increases the dose each week. While Topamax does not cure ailments, it is a way to control seizures and migraine headaches. Women with a history of seizures cannot abruptly discontinue the use of Topamax, as they increase the risk of having a seizure. The dose needs to be decreased gradually over several weeks.

Topamax received government approval in 1997 for the treatment of seizures and developmental delay disorder known as Lennox-Gastaut Syndrome. In 2004, the FDA approved Topamax for adults to help prevent migraine headaches. It is considered to be one of the top-selling prescription drugs in United States, grossing more than an estimated two billion dollars. Topamax was originally developed by Ortho-McNeil Neurologics and Noramco, Inc, but its generic versions have been manufactured by companies such as Apotex, Barr Laboratories and Cobalt Laboratories.

The FDA estimates there are approximately 32.3 million prescription for Topamax filled from 2007 to 2010, with most of these prescriptions being filled by women of childbearing age who suffer from migraine headaches. If you or a loved one took Topamax while pregnant and had a baby born with an oral birth defect or other developmental deformity we urge you to call Greg Jones Law today to protect your legal rights. Our firm can help you get the compensation you deserve.

Call Greg Jones Law at 855-566-3752 or contact us online.

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