Topamax (topiramate) Linked to Birth Defects!

The drug Topamax (topiramate) has recently been associated with an increased risk of dangerous birth defects

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In March 2011, the U.S. Food and Drug Administration (FDA) issued a warning that women taking Topamax, or a generic equivalent, during the first trimester in their pregnancy face an increased risk of having a baby born with birth defects. The warning came shortly after studies indicated that the risk of a newborn suffering birth defects was six to eleven times higher for women taking Topamax than for women who have not taken the drug. As a result of these studies, the FDA is now requiring that the manufacturers of Topamax and topiramate place a stronger warning label on the drugs in order to adequately inform consumers about the increased risk.

Birth defects associated with the use of Topamax may include:

  • Cleft palates
  • Cleft lips
  • Genital defects
  • Other birth malformations

Topamax is typically used as a seizure medicine, also called an anticonvulsant medication, to treat epilepsy. Epilepsy is a neurological disorder which results in recurring, uncontrolled seizures. Additionally, the drug is used to prevent migraine headaches and reduce the incidence of migraine attacks. Many doctors have also used Topamax for off-label purposes, including the treatment of bipolar disorder.

Recent research suggests that, despite the risks associated with Topamax, sales for the drug reached $538 million in 2010, after its patent expired. In 2008, prior to the expiration of the drug’s patent, sales for Topamax reached over $2 billion.

Johnson & Johnson markets Topamax, which is the brand name for topiramate. Topamax was approved by the FDA in 1996. According to the FDA’s website, from January 2007 to December 2010, an estimated 32.2 million topiramate prescriptions were issued.

The FDA has advised all women who are pregnant or who may become pregnant to be familiar with the possible risks associated with Topamax, as birth defects may begin to develop early on, sometimes even before a woman may know that she is pregnant.

PLEASE SPEAK WITH YOUR DOCTOR BEFORE DISCONTINUING THE USE OF TOPAMAX OR ANY OTHER PRESCRIPTION DRUGS.

Contact the Law Offices of d'Oliveira & Associates, P.C.

The attorneys at the Law Offices of d'Oliveira & Associates are affiliated with some of the best and most experienced pharmaceutical attorneys in the country.  The Law Offices of d’Oliveira & Associates can provide you with the legal representation you need. You should have a personal injury lawyer on your side, to help you make important personal and legal decisions.

Please contact the Law Offices of d'Oliveira & Associates at 1-800-992-6878 or fill out a contact form for a free legal consultation.

Fill out the contact form below or call: 1-800-992-6878 if you or a loved one has been injured by Topamax

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