[SSRI-Research] LA Times - Study Ties Epilepsy Drug to Fetal Risk

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Wed, 09 Aug 2006 21:37:47 -0400

[sSRI-Research] LA Times - Study Ties Epilepsy Drug to Fetal Risk

 

 

 

 

Gang, Depakote is the second drug of choice for bipolar disorder.

This study found that **children born to _/twenty percent/_ of mothers

taking the drug** **had malformed hearts and genitals, cleft palate and

artery deformities.

 

What is really infuriating about this, is Abbott and the FDA /had to

have known/ this all along, but minimized this with these two

obfuscating lines buried deep in the PDR.

 

**Pregnancy---Valproic acid, valproate sodium, and divalproex have been

reported to cause birth defects when taken by the mother during the

first 3 months of pregnancy. Also, animal studies have shown that

valproic acid, valproate sodium, and divalproex cause birth defects when

taken in doses several times greater than doses used in humans.

http://www.nlm.nih.gov/medlineplus/druginfo/uspdi/202588.html

*

*It says there have been cases of birth defects reported, but

_/doesn't give the magnitude of the problem/_.

 

Bullshit. ONE in FIVE is /_catastrophic_/.

 

It then alludes to animal experiments that used megadoses of

valproate, and _/implies this was due to dose!/_*

 

*I'm horrified.

 

Vince

*

 

 

 

http://www.latimes.com/news/printedition/asection/la-sci-epilepsy8aug08,1,295990\

3.story?coll=la-news-a_section

/From the Los Angeles Times/

 

Study Ties Epilepsy Drug to Fetal Risk

 

* By Denise Gellene

Times Staff Writer

 

August 8, 2006

 

One in five women who took the widely used epilepsy drug valproate in a

clinical trial had pregnancies resulting in birth defects or fetal

death, researchers said Monday.

 

The drug, sold as Depakote by Abbott Laboratories Inc., was

substantially riskier to unborn children than three competing medicines

examined in the study. The researchers found cases of malformed hearts

and genitals, cleft palate and artery deformities among children born to

women taking the drug.

 

The report in the journal Neurology was the latest to document the

potential dangers of valproate to fetuses. The drug is also used to

treat headaches and some psychiatric conditions, including bipolar

disorder.

 

Dr. Brien J. Smith, a neurologist at Henry Ford Hospital in Detroit,

said that the study was convincing and that doctors should now avoid

prescribing valproate for women of childbearing age.

 

Epilepsy is a disorder in which clusters of nerve cells in the brain

signal abnormally, causing seizures. An estimated 2.7 million Americans

are affected. Valproate has long been the preferred drug for treating

generalized epilepsy, a form that affects half of patients.

 

The researchers, led by Dr. Kimford J. Meador of the University of

Florida in Gainesville studied 333 pregnant women at 25 centers in the

U.S. and England.

 

The women had been taking one of four drugs --- valproate,

carbamazepine, phenytoin or lamotrigine --- when they became pregnant

and continued use during their pregnancy.

 

Twenty percent, or 14, of the 69 women on valproate had pregnancies that

resulted in fetal deaths or birth defects.

 

For phenytoin, which is sold as Dilantin, six of 56 women, or 11%, had

pregnancies ending in fetal death or congenital malformations.

 

Nine of the 110 women who took carbamazepine (Tegretol), or 8%, had

pregnancies that ended in fetal death or birth defects. The rate for

lamotrigine (Lamictal), was 1% --- one of 98 women on the drug.

 

Meador said the results showed that valproate should not be the drug of

first choice for women of childbearing age.

 

But he added that it was less clear what the alternative should be.

 

He was reluctant to declare Lamictal the safest drug of the four because

other studies had found a higher rate of birth defects associated with

its use.

 

He also said pregnant patients should continue to take their epilepsy

medicine because seizures could be dangerous for them and their unborn

children.

 

Women of childbearing age who must take valproate --- because they don't

respond to other drugs, for example --- should take the lowest dosage

possible, Meador said.

 

Researchers will monitor the children of the women in the study for six

years to see whether they have cognitive problems related to the drugs,

he said.

*