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Author Topic: TOPAMAX CAUSES BIRTH DEFECTS  (Read 10117 times)
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F.A.I.T.H.
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« on: April 12, 2011, 08:41:56 PM »

THIS AFFECTS ME PERSONALLY BC I WENT TO MY NUERO. TOLD HIM I WANTED TO START A FAMILY AND THT I WANTED TO BE TAKEN OFF MY TOPAMAX AND ALL HE DID WAS DECREASE THE DOSAGE FROM 4 A DAY TO 2 A DAY AND TOLD ME THT TOPAMAX WAS SAFE TO TAKE WHILE TRYING TO CONCIEVE AND ALSO DURING PREGNANCY. THEN MY MAMA AND I ARE WATCHING TV ONE DAY AND A COMMERCIAL COMES ON TV BOUT THE FDA WARNING PEOPLE NOT TO TAKE IT IF TRYING TO CONCIEVE AND IF YOUR CHILD HAS BIRTH DEFECTS TO CALL A LAWYER. IM SO ANGRY..  Shocked O :oNCE AGAIN MY DOC LIES TO ME AGAIN!! WE GO TO OUR DOCTORS BC WE TRUST THEM!!! NO MORE!! IM DONE!!!!!!!!!!!!1
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dennis100
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« Reply #1 on: April 12, 2011, 09:53:10 PM »

Welcome aboard F.A.I.T.H.

Was your neuro appointment before or after 3/04/11 ?


FDA NEWS RELEASE

For Immediate Release: March 4, 2011
Media Inquiries: Sandy Walsh, 301-796-4669, sandy.walsh@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA: Risk of oral birth defects in children born to mothers taking topiramate

New data suggest that the drug Topamax (topiramate) and its generic versions increase the risk for the birth defects cleft lip and cleft palate in babies born to women who use the medication during pregnancy, the U.S. Food and Drug Administration said today.

Before prescribing topiramate, approved to treat certain types of seizures in people who have epilepsy, health care professionals should warn patients of childbearing age about the potential hazard to the fetus if a woman becomes pregnant while using the drug.
Topiramate also is approved to prevent migraine headaches, but not to relieve the pain of migraines.

“Health care professionals should carefully consider the benefits and risks of topiramate when prescribing it to women of childbearing age,” said Russell Katz, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “Alternative medications that have a lower risk of birth defects should be considered.”

Cleft lip and cleft palate, collectively called oral clefts, are birth defects that occur when parts of the lip or palate do not completely fuse together early in the first trimester of pregnancy, a time when many women do not know they are pregnant. The defects range from a small notch in the lip to a groove that runs into the roof of the mouth and nose, possibly leading to problems with eating, talking, and to ear infections. Surgery often is performed to close the lip and palate and most children do well after treatment.

Data from the North American Antiepileptic Drug (AED) Pregnancy Registry indicate an increased risk of oral clefts in infants exposed to topiramate during the first trimester of pregnancy. Infants exposed to topiramate as a single therapy experienced a 1.4 percent prevalence of oral clefts, compared with a prevalence of 0.38 percent – 0.55 percent in infants exposed to other antiepileptic drugs.

Infants of mothers who did not have epilepsy and were not being treated with other antiepileptic drugs had a prevalence of 0.07 percent. Similar data from the United Kingdom Epilepsy and Pregnancy Register supported the North American AED Pregnancy Registry data.

Based on the data, topiramate will have a stronger warning in its prescribing information (labeling). The pregnancy category will be changed to Pregnancy Category D. This means that there is positive evidence of human fetal risk based on human data, but the potential benefits of the drug in pregnant women may outweigh the risks in certain situations. The FDA previously designated the drug as Pregnancy Category C because of the lack of human data. More information about the Pregnancy Categories can be found in the FDA’s Drug Safety Communication1.

The patient medication guide and prescribing information for Topamax and generic topiramate will be updated with the new information.

Before starting topiramate, pregnant women and women of childbearing potential should discuss other treatment options with their health care professional. Women taking topiramate should tell their health care professional immediately if they are planning to or become pregnant. Patients taking topiramate should not stop taking it unless told to do so by their health care professional.

Women who become pregnant while taking topiramate should talk to their health care professional about registering with the North American Antiepileptic Drug Pregnancy Registry2 (http://www2.massgeneral.org/aed/), a group that collects information about outcomes in infants born to women treated with antiepileptic drugs during pregnancy.  

For more information:

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

http://www.fda.gov/Drugs/DrugSafety/ucm245085.htm


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- - Links on this page: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm245594.htm

« Last Edit: April 12, 2011, 10:39:11 PM by dennis100 » Logged
Dispatch
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« Reply #2 on: April 12, 2011, 10:18:10 PM »

 Smiley HI F.A.I.T.H and WELCOME!  Love your screen name! 

I did not have good results using that med, and actually thought I was going to shake right outta my body from the inside out.  It does not surprise me this drug would injure a fetus.  I hope you've considered a 2nd opinion to get yourself off Topamax and on another med...I went to Keppra after Topamax, but I am unaware of pregnancy issues with that med.  Do you have VNS or are you considering it?

Again, WELCOME and looking forward to hearing from you again!

Cool
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« Reply #3 on: April 13, 2011, 09:38:12 AM »

hello dennis and dispatch nice to chat with yall again..  Smiley anyway to answer yalls questions i do have the vns have had it since 01 was having complications from the vns  so it was turned off... my doctor never told me anthing bout birth defects to answer your other question at my appt tht was in nov. of 2010
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« Reply #4 on: April 13, 2011, 12:40:29 PM »

I'd be pissed!!!  Topamax never worked for me. Of course nothing else did either!
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« Reply #5 on: April 18, 2011, 11:14:57 PM »

 Smiley HEY F.A.I.T.H!

Do you still have the VNS in your body?  I have found with doctors that they assume everyone they come across has knowledge and if you don't ask, they don't tell, and even if you do ask, it doesn't mean they'll answer truthfully.  Big pharma and device manufacturers have an evil spell cast on docs called money...

Cool
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"I reckon it's again my turn to win some or learn some..." Jason Mraz

ALL MY POSTINGS ON THE VNS MESSAGE BOARD ARE NON-TRANSFERABLE
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« Reply #6 on: April 22, 2011, 03:17:13 PM »

yes i still have the VNS in my body i went for a second opinion on removing the vns and the dr told me that it was better to leave the stimulator in my body at that time which was a couple years ago then to try and remove it. cause it had already been turned off so they really didnt see a need to bother with it ..  then he said if he did remove it that i would have the coils for life because of all the scar tissue damage and he said it was high risk because of the nerve damage he thought i had.
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« Reply #7 on: May 18, 2011, 09:26:06 PM »

 Cheesy HI F.A.I.T.H!

Some docs will leave the whole device in a person if it isn't causing problems being left in there.  And hearing he would leave the coils in due to scar tissue & nerve damage is quite common.

How ya doing?

Cool
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VNS for TRD implant November, 2006.  Complete device removal including coils April, 2008.

"I reckon it's again my turn to win some or learn some..." Jason Mraz

ALL MY POSTINGS ON THE VNS MESSAGE BOARD ARE NON-TRANSFERABLE
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