February 7, 2023

The following timeline illustrates the history of topamax from its original inception to the recent discovery of topamax related birth defects this presentation is brought to you by chaffin lu hana a national law firm that can be reached at one eight eight eight four eight zero one one two three topiramate the active ingredient in topamax was discovered in 1979 by

Bruce marienhof and joseph gardocki while conducting research at mcniel pharmaceutical in 1996 topamax was approved by the fda for treating seizures in epileptic patients since 1996 topamax is safety label merely stated that there were no studies using topamax in pregnant women and noted harmful effects exhibited by pregnant mice that were given doses of the drug

During experimental animal testing in 2001 the fda issued a warning that topiramate found in topamax could cause blindness in some patients at that time or filmic neal updated its topamax label to include the risk of acquiring acute myopia and secondary angle closure glaucoma but no consideration was given to changing the drugs pregnancy warning in 2004 topamax was

Approved by the fda for use in preventing the occurrence of migraine headaches despite the drug becoming available to a much larger market topamax is pregnancy warning remained unchanged in 2006 milan labs released two puritan the first generic form of topamax to be approved by the fda competition between different drug makers led to an increase in the number of

Patients using topiramate even so no pregnancy warning was added in the july 2008 issue of neurology the american academy of neurology published preliminary findings of the uk epilepsy and pregnancy registers linking to a pyramid to oral cleft birth defects the data collected by the group showed the risk of major congenital malformation in children born to women

Who were using to pyramid during their pregnancies than in the around population again however no warning was added to topamax or topiramate indicating the risk of birth defects and pregnant women ortho mcneil’s exclusive right to manufacture to pyramid based drugs like topamax expired in 2009 generic forms of topamax subsequently flooded the market in 2010 ora

Thermic neo pled guilty to violating the food drug and cosmetic act by promoting topamax for psychiatric uses not previously approved by the fda and without supporting safety data from any controlled clinical trial related to psychiatric topamax therapies ortho mcneill was sentenced to six point fourteen million dollars in criminal fines and seventy five point

Thirty seven million dollars in civil fines also in 2010 the north american anti-epilepsy drug pregnancy registry publicly disclosed data it had been collecting since 1997 relating to topamax in an increased risk of oral cleft birth defects the data was consistent with the european findings released two years prior as it found that pregnant women who received

Topamax treatment were up to twenty times more likely to produce offspring with oral cleft disfigurements yet again however the pregnancy warning on the toba max safety label went unchanged most recently on march 4th 2011 the fda issued a public health warning regarding topamax is linked to oral cleft birth defects after considering the findings of the north

American and european pregnancy registries the fda also required ortho macneill to change the safety label for topamax to reflect the documented risks present for pregnant women taking the drug in addition topamax was reclassified from a pregnancy category c drug to a pregnancy category d drug meaning that its effects were studied in pregnant women and found to

Have the potential to cause significant unreasonable harm to a human fetus it is unknown just how many children have been affected by topiramate caused birth defects with 32 million to appear m8 prescriptions dispensed to 4.3 million patients from 2007 to 2010 it is clear that a large number of individuals who may have been armed if you are a family member used

Topamax or to a pyramid during pregnancy and subsequently delivered a child with a birth defect contact chaffin lu hana today for a free confidential and no-obligation case evaluation at one eight eight eight four eight zero one one two three don’t wait contact champion lu hana now at eight eight eight four eight zero one one two three

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Topamax Lawyer – A Historical Timeline of Topamax Side Effects By Chaffin Luhana LLP Injury Lawyers