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 Drugs.com list of FDA category ratings.
