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Topamax Lawsuit

Topamax can result in serious birth defects such as cleft palate or cleft lip.  These abnormalities occur when parts of the soft and hard palate fail to completely fuse together.  The defect can result in a notched lip, or in severe cases, an open groove that extends from the nose to the roof of the mouth.  Cleft lip and cleft palate birth defects can also cause problems eating and communicating, and can increase the risk of ear infections.

Topamax Problems

In 2009, the makers of Topamax were accused by the Department of Justice of promoting the drug to physicians for unapproved purposes.  Such promotions are called “off label” since they encourage use of the drug for purposes not listed on the packaging, and therefore not approved by the FDA.  As a result, the manufacturers of Topamax plead guilty and paid $75.37 million for violating the False Claims Act, as well as $6.14 million in criminal fines.

What is Topamax?

Topamax is an anti-convulsant drug used to treat epileptic seizures.  In addition, Topamax is also prescribed to help prevent migraine headaches.  The chemical name for Topamax is Topiramate, and its generic name is Topiragen. 

Topamax Lawsuit

A product liability or defective product claim for Topamax is a type of pharmaceutical claim in which a person is injured as the result of taking a medication.  When a drug is prescribed by a doctor, it is usually assumed that the medicine will help treat a medical condition or help in recovery.  Unfortunately, some drugs have dangerous side effects which can be serious or even life-threatening.  The cleft lip and palate birth defects were not originally listed as side effects of Topamax, prompting the FDA to update the pregnancy warnings.

Help If You’ve Been Injured by Topamax

At O’Hanlon, McCollom & Demerath, our attorneys understand that your child’s birth defect may not be your fault – instead, possibly a side effect of Topamax.  Our expertise and experience, combined with our highly trained staff, make us uniquely well-equipped to handle even the most complex products liability claims.  If you suspect your child has a Topamax injury such as cleft palate or cleft lip, and you need to talk to a seasoned team of professionals, please contact us immediately for a free consultation.

Topamax has been shown by numerous studies to cause serious birth defects, such as cleft lip or cleft palate. Serious malformations may require expensive surgery or speech therapy, which can be costly. If your infant has a congenital birth defect due to Topamax, we can help you obtain the compensation you deserve to properly treat the defect. Contact our firm today to see if you qualify for a Topamax lawsuit.

What was Topamax prescribed for?
Topamax is prescribed to treat epileptic seizures, as well as for the prevention of migraines. However, Topamax has been applied for many off-label uses, such as bulimia, post traumatic stress disorder, obesity, and smoking cessation.

What kinds of birth defects does Topamax cause?
The most common types of birth defects caused by prenatal use of Topamax are oral clefts, including cleft lip and cleft palate. However, Topamax has been linked to various types of congenital defects.

Why did the FDA issue a new warning for Topamax?
In March, the FDA increased the pregnancy warning for Topamax to Category D, which means there is positive evidence of fetal risk.

What are some of the side effects of Topamax?
The most common side effects of Topamax are numbness and tingling, fatigue, taste change, weight loss, memory loss, and difficulty concentrating.

What are oral clefts?
Oral clefts are abnormalities that occur when the areas of the lip and palate fail to fuse together. Cleft lip or cleft palate can cause speech problems, as well as ingestion issues.

When did the FDA approve Topamax?
Topamax was approved to treat epileptic seizures in 1994. In 2004, the FDA approved is for use in the treatment of migraines.

Why did the Department of Justice indict the manufacturers of Topamax?
The manufacturers of Topamax were accused of promoting the drug for unapproved purposes, violating the False Claims Act.

Is Topamax sold under any other names?
Yes. A generic version of Topamax was approved in 2006, called Topiragen. It is distributed by Mylan Pharmaceuticals.

Who are the manufacturers of Topamax?
Ortho-McNeil Neurologics and Noramco, Inc. discovered Topamax in 1979. Both companies are divisions of Johnson & Johnson.

How do we know that Topamax causes birth defects?
The UK Epilepsy and Pregnancy Register, as well as the North American ARF Pregnancy Registry, noted a higher incidence of oral clefts in children whose mothers took Topamax during pregnancy.

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