More Evidence That Topamax Manufacturer Is Responsible For Birth Defects

Posted by Jonathan Rosenfeld on April 28, 2011

I've written a lot about the serious problems associated with use of Topamax during pregnancy.  After all, the FDA ordered Topamax to be re-labelled and re-classified in March, 2011 in response to data suggesting a conclusive correlation between Topamax usage by pregnant woman and birth defects such as: cleft lip, cleft palate, Spina Bifida, facial defects and pediatric heart problems.

The swift decision to change the classification / labelling of Topamax is mainly due to the data collected by the FDA.  The FDA collects information about problems associated with all drugs in an Adverse Event Database.  According to the FDA's adverse Event Report database:

  • There are 244 safety reports concerning Topamax users who believe their child was adversely affected by the drug
  • 114 of the 244 safety reports (approximately 47%) are related to birth defects
    • 12% of adverse complaints are related to cleft lip / cleft palate
    • 12% of the adverse complaints relate to limb malformation such as: cleft hand foot defects
    • 11% of adverse complaints are heart related
    • 10% of adverse complaints relate to facial defects
    • 6% of adverse complaints relate to spinal defects

Off Label Uses Of Topamax

Topamax was originally approved by the FDA as a drug to treat epilepsy in 1996.  In 2004, the FDA approved Topamax to treat migraine headaches. 

Despite its limited approved uses, Ortho-McNeil was illegally promoting Topamax to treat conditions such as bipolar mood disorder, alcohol dependence and weight loss for several years. 

In May, 2010 Ortho-McNeil plead guilty and and paid fines of more than $81.5 million for their off-label promotion of Topamax to broad range of people for which the drugs safety was never approved.

Certainly, the more information that comes to light regarding Topamax birth defects and marketing, it is becoming more apparent that scope of potential pharmaceutical claims against Ortho-McNeil and various generic manufacturer are indeed quite strong.  As we learn more about this troubling situation, I encourage you to give my law office a call or email us a contact form and allow us to begin an evaluation of your case.

Related:

Topamax Injuries: Drug's Impact On Effectiveness Of Birth Control May Have Contributed To Outburst Of Birth Injuries

New FDA Warnings Suggest Correlation Between Topomax And Birth Defects Including: Cleft Lip & Cleft Palate

May 21, 2010: Ortho-McNeil Pharmaceutical, LLC Pleads Guilty to Illegal Promotion of Topamax and is Sentenced to Criminal Fine of $6.14 Million FDA

FDA Drug Safety Communication: Risk of oral clefts in children born to mothers taking Topamax (topiramate)

New FDA Warnings Suggest Correlation Between Topomax And Birth Defects Including: Cleft Lip & Cleft Palate

Posted by Jonathan Rosenfeld on March 14, 2011

topamaxA new FDA warning was recently published which warns women of childbearing age that their use of Topomax (and other generic variations known as topiramate) significantly increases their chances of giving birth to a child with mouth-related birth defects.

Topiramate is a widely used prescription medication used to control epilepsy and severe headaches.

Women taking Topomax were more than three times more likely to give birth to a child with birth defects related to a child’s mouth such as: cleft lip or cleft palate compared with women taking other brands of epilepsy drugs.  Researchers estimate that infants born to women taking Topomax have a 1.4% chance of a having a birth defect relating to their mouth.

As a result of the new disclosures, the FDA is requiring Johnson & Johnson, the manufacturer of Topomax and other generic Topomax manufacturers to incorporate stronger warnings about use and pregnancy.

Children born facial deformities frequently face difficulties during their formative years as other children may ridicule for no reason.  Making matters more difficult is that many children faces a series of surgical procedures to remedy deformities. 

Depending on the location of the deformity, children may have to wait through adolescence to undergo some of the cosmetic surgery procedures due to the fact that some procedures may be unreasonable to perform during periods of substantial growth and development.

As we learn more about the correlation between Topomax usage and the development of cleft lip and cleft palate, Rosenfeld Injury Lawyers remain committed to protecting the legal rights of infants and children impacted by this dangerous drug—Topomax.  Many of our expected lawsuits and claims against Topomax manufacturers Johnson & Johnson and McNeil will focus on the companied knowledge of birth defects in related studies performed both on animals and trial-groups.

If you believe your child’s birth defects may be related to Topomax use, please don't delay--give us a call for free legal consultation today regarding your potential Topamax lawsuit or Topamax claim.  Our legal consultations are always free and confidential. (888) 424-5757

Related:

Cleft lip and palate repair Medline Plus

Smiletrain.org

Cleft Lip / Cleft Palate FAQ's Lucille Packard Children's Hospital at Stanford

About Jonathan Rosenfeld

Photo of Jonathan Rosenfeld

About Jonathan Rosenfeld My law practice is focused on representing the most vulnerable members of our society in claims and lawsuits...

Read More

Subscribe

Add this blog to your feeds or subscribe by email using the form below

Begin the process of learning the legal options available for your child today.

Bed Sore FAQs

Frequently asked questions on bed sore prevention, treatment and legal rights of those who have been neglected.

View FAQs
Nursing Home Laws - View Laws by State