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Breaking News      Johnson & Johnson: Birth Defects Rise After Topamax Says US FDA
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06 March 2011
06 March 2011

 
Johnson & Johnson: Birth Defects Rise After Topamax Says US FDA
 
It’s a drug marketed to relieve migraines and prevent seizures for
epilepsy,  but the manufacturer, multinational pharmaceutical company
Johnson & Johnson in hot water, again over Topamax.
 
This week the United States Food and Drug Administration released
new data that indicates Topamax, or Topiramate, has caused cleft lips
and cleaved palates in

twenty times that of normal pregnancies or where women are not using
the medication.

 
The danger is most profound in the first trimester, where the
incident of cleft lips and palates increased from 0.55 of a percent to
1.4% for women taking the medication.
 
Last year Johnson and Johnson were found guilty of improperly
marketing the drug as a treatment for bipolar and drug and alcohol.  In a
court settlement the multinational agreed to pay $81 million.
 
The FDA has now insisted that Johnson & Johnson give clear
warnings and that doctors and medical staff provide women with clear
information about the dangers of using Topamax for women who are either
pregnant or planning to get pregnant.
 
Currently on the packaging of Topiramate women are warned, but the directions from the FDA will give a far stronger message.

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References:

http://online.wsj.com/article/BT-CO-20110304-711442.html

http://www.businessweek.com/news/2010-05-21/j-j-unit-pleads-guilty-to-improper-topamax-marketing-update2-.html

http://www.montrealgazette.com/business/Epilepsy+drug+boosts+risk+oral+birth+defects/4388318/story.html

 
 
Thank you very much to Lawrence who sent in the following comment:
 
Hi,
  Topamax for my athlete, AP student son’s epilepsy led to his
confinement  for a week and discontinuation of use. His neurologist had
increased the rate and it was apparently too much and he went bonkers. 
It was a scary week for
us.  You can find allusions similar to this event in an Internet
search.  My older brother a board certified physician asked around among
the neurologists in Houston and learned that is was not an isolated
event.  It is probably another one of these covered up side effects. 
This was 4 years ago. He was able to go back to school within the month,
but it took 2-3 years for him to seem himself.
Lawrence Fisher
 
 
Also thank you to Farid for sending in the following question.  Does anyone know the answer?
 

Hi
How about if you were using trilaptal ( med cor sizure )when you were 4 years old for 3 years pls

Regards,
Farid



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