Topamax Timeline

The following is a timeline of events in the discovery of Topamax symptoms of side effects (birth defects) in infants:

1979 – Topamax is developed by Ortho-McNeil Neurologics and Noramco, Inc. – both divisions of Johnson & Johnson

1996 – Topamax is approved for treatment of epileptic seizures

1997 – Study by North American Antiepileptic Drug (NAAED) Pregnancy Registry begins

2001 – Possible link between Topamax and blindness or glaucoma

2004 – Topamax is approved for treatment of migraine headaches

2006 – Generic topiragen is approved

2008 – (April) Link between Topamax and birth defects (cleft palate) – study published in American Academy of Neurology

2009 – Topamax patent expires and generic forms of the drug flood the marketplace

2010 – (March) Off-label promotion of Topamax results in Whistleblower lawsuits and $80 million in settlements

2011 – The North American Antiepileptic Drug Pregnancy Registry finds that 1.4 percent of infants exposed to topiramate during the first trimester — or about 1 of every 65 infants develop cleft lip and/or palate. Those findings confirm data being reported by officials in the United Kingdom.

2011 – (March 4) FDA warning changed to category D, which means: “There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.” This information was taken from list of FDA category ratings.