Topamax Lawsuits

Topamax lawsuits have been all over the news recently and for good reason.  The FDA issued a warning in March 4, 2011 that this epilepsy and migraine drug is more dangerous during pregnancy than originally stated. The FDA informed the public that based on new data they determined that female patients taking Topamax or its generic form were at increased risk of their babies being born with a cleft lip, cleft palate and, hypospadias which is a mal-formation of the penis or vagina. There are a high number of babies born with cleft palates, cleft lips, genital malformations and other birth defects and the mothers of these babies are looking for compensation.

Also sold as the generic form Topiramate, Topamax is manufactured by the Ortho-McNeil Neurologic Company which is part of the Johnson & Johnson manufacturers.  The drug has been used to treat epilepsy and seizure disorders and was also found to prevent migraines.  Women in their childbearing years are exceptionally prone to migraines and Topamax has been prescribed in the United States for several years.

One of the first studies completed was published in a medical journal, Neurology, and identified a link between the drug Topamax or Topiramate and an increased risk of birth defects.  When the study came out in July of 2008 the babies studied were found to develop a cleft palate or lip eleven times higher than would normally be expected.  In the same study male babies were found to develop genital defects fourteen times higher than normal.  Because of the new information and further studies and testing the FDA made the recommendation to increase the risk warning from a C to a D which means human testing has found serious results.

Unfortunately the most recent reports have concluded that taking Topamax during pregnancy is affecting the unborn baby.  Most of the women taking the drug were unaware of the severity of side effects and possibility for birth defects.  Taking the drug Topamax or Topiramate, especially during the first trimester of pregnancy, has resulted in babies born with a cleft lip or cleft palate.  This is characterized by a hole in the lip that may go all the way up to the nose.  The deformation must be corrected with surgery and is usually performed in the first year of life.  The current Topamax lawsuits and Topamax Class Action suits being filed are to provide compensation for the families affected by the drug.

This medication is an anticonvulsant drug approved by the Federal Food and Drug Administration (FDA) for solo therapy or with other medicine to control patients who have epilepsy with certain types of seizures. This medication also holds FDA-approval for prevention of migraine headaches. It is for prevention only and not to be used for treatment of migraine headache symptoms. Topiramate is also used off label for other medical conditions.

This is not the first time Topamax has had a post-marketing problem. In 1996, the FDA approved Topamax for seizure control in epileptic patients. In 2004, the FDA expanded the drug’s labeled use to include prevention of migraines. On September 26, 2001 the FDA issued an order to the manufacturer, Ortho-McNeil, to revise the prescribing information to include a warning that the use of Topiramate could lead to a syndrome that includes acute myopia associated with secondary angle closure. Dr. Russell Katz, then chief of neurological drugs for the FDA said: “There’s no question that the thing to do is to stop the drug. For the most part, that turns out to be enough.”

Symptoms of the syndrome include:

• Acute onset of decreased visual acuity
• Ocular pain

Symptoms of the syndrome appear about one month after therapy with Topamax begins. Discontinuing the drug immediately after symptoms appear usually is all that needs to be done. However, continuing treatment can lead to permanent eye injury.

Information developed by the North American Antiepileptic Drug Pregnancy Registry… Their data showed an increased risk in infant abnormalities in fetuses exposed to Topiramate mono-therapy during the first trimester. Similar results came from the United Kingdom Epilepsy and Pregnancy Registry.

Based on the data the risk of a cleft lip is 16 times more likely in children born of mothers taking Topamax than the risk of babies whose mothers did not take it – 0.2 percent of babies. Cleft lip, cleft palate and, hypospadias can be corrected surgically.

In response to the data the FDA has changed the designation of Topiramate from Pregnancy category D. This move means that the FDA has confirmed positive data evidence of human fetal risk but the potential benefits for use of the drug by pregnant women may outweigh the risks.

Already, pharmaceutical product liability attorneys have begun suits against Ortho-McNeil both on behalf of individual patients as well as Topamax class action lawsuits.

The FDA is urging doctors to discuss Topamax and alternative therapies for women who are pregnant or plan to become pregnant. In addition, they strongly suggest that physicians carefully weigh the risks and benefits in woman of child-bearing age and consider an alternative treatment.

If you or someone you know has been affected by this drug, calling a lawyer familiar with the Topamax lawsuits is important.  You deserve to be compensated for the financial drain and emotional scars left from using the drug Topamax without proper warnings.  You may be able to join one of the Topamax class action lawsuits already in progress.