December 03, 2009

FDA Issues Major Birth Defects Warning For Depakote

Depakote, Abbott's widely-used anti-convulsant for epilepsy and bipolar disorder, today was the object of a major FDA warning.

"The FDA notified health care professionals and patients about the increased risk of neural tube defects and other major birth defects, such as craniofacial defects and cardiovascular malformations, in babies exposed to valproate sodium and related products (valproic acid and divalproex sodium) during pregnancy. Healthcare practitioners should inform women of childbearing potential about these risks, and consider alternative therapies, especially if using valproate to treat migraines or other conditions not usually considered life-threatening.

"Women of childbearing potential should only use valproate if it is essential to manage their medical condition. Those who are not actively planning a pregnancy should use effective contraception, as birth defect risks are particularly high during the first trimester, before many women know they are pregnant."

Wow is about all I can say. In branded or generic form, Depakote is a drug taken by millions of American women and yet I have not seen a single press mention yet of the FDA's new warning. Abbott is under investigation by the feds for its marketing of Depakote. The FDA earlier this year urged a review of the drug's possible connection to developmental delay and autism. It has an FDA mandated warning for suicidality. A New England Journal of Medicine study linked the drug to lower IQs in the offspring of women taking the drug. And the drug is linked to an increased risk of ovarian cysts.

What a lovely drug.

Posted by Philip Dawdy at December 3, 2009 12:41 PM
StumbleUpon Toolbar del.icio.us Digg it reddit
Comments

Excuse me, but how is this news? This has been known for a VERY long time, and all the textbooks going back several decades describe the greatly elevated risk of neural-tube defects when pregnant women take valproic acid.

In fact, in my opinion it's one of the "success stories" in getting doctors to seriously evaluate the risk/benefit ratio of the meds we prescribe.

Posted by: SteveBMD at December 3, 2009 01:36 PM

Success? deep belly laugh...my doc encouraged me to get pregnant ALL THE TIME while on depakote and 4 other drugs too. Good man. Thought I’d be a good mom. Luckily I was a good mom and never had those babies.

Posted by: Gianna at December 3, 2009 01:58 PM

My daughter took Depakote for 6 years starting at age 11 in 1999, until 2005. In 2006 a psychiatrist at a prestigious hospital diagnosed her with Polycystic Ovary Syndrome, as a direct result of using Depakote.

Depakote is an anti convulsant drug often prescribed for use in Bipolar Disorder treatment and carries a black box warning for use in women under age 20 for the Polycystic Ovary Syndrome.

This is a permanent body damage my daughter suffered as a result of using this drug, with a now increased chance of cervical cancer as a result of never menstruating due to POS.

Posted by: Stephany at December 3, 2009 02:40 PM

Gianna,

Well then, you have an incompetent doc. The Depakote-NTD risk was drilled into my head since day 1 of med school.

Just because you had a doctor who ignored what he was most certainly taught, doesn't mean that the whole field is ignorant and corrupt.

Posted by: SteveBMD at December 3, 2009 03:00 PM

I won't name my doc but he's a big shot and well regarded...I know psychiatry Steve...at least now I do...

lots of "good" docs are crocks...unfortunately

Posted by: Gianna at December 3, 2009 03:25 PM

Scores of doctors are telling their patients it's safe to be on antidepressants while pregnant. That's because withdrawal is so dangerous the docs don't want to be blamed for it while the birth defects are harder to pin on the drug but they are occurring in record numbers now on all the SSRIs. This is a crisis of major proportions brewing as mothers are routinely put on a/ds for postpartum depression and they don't get off before getting pregnant again. It's truly ugly. Again the cost to the health care system of this rampant prescribing of psych drugs is overwhelming in all sorts of indirect ways.

Posted by: Sara at December 3, 2009 03:40 PM

Dear SteveBMD

I don't believe that was the point being made "doesn't mean that the whole field is ignorant and corrupt".

Medicine with hopefully a vast majority being those non-ignorant and non-corrupt doctors, clearly appear to not hold those ignorant and corrupt doctors accountable by direct public sensor or by suspending/removing their medical license's; so the bad medicine they practice does reflect directly across the board upon the whole field of medicine as it rightfully should.

Medicine needs to start taking both unethical and bad practices seriously; or the damage done may come to a point where the lost "Public Trust" will become a systemic problem continuing into the foreseeable future.

It's pretty cut and dry even in layman's terms: If you can't trust the medicines your doctor prescribes to be safe and effective with full informed consent; then you really can't trust the doctor's prescribing them.

The ball is really in profession medicine's court to address and rectify these major problems. They have helped create them, and they have to be force driving the solution.

That is just my personal patient prospective on the issue.

Posted by: MsPiggy at December 3, 2009 04:44 PM

I just don't understand what all of these drugs are used for. I took Depakote and Risperdal for a time, but I was never diagnosed as bipolar and neither of these drugs did anything, except contribute to sexual dysfunction and weight gain. Thankfully, cold turkey withdrawal from them was easy (for me at least).

Posted by: Tony at December 3, 2009 04:46 PM

Now, just to be clear: which drugs, in your mind, are safe? OH, that's right - NONE of them. Maybe a good reason not to take them - except when the benefits outweigh the risks.

And, as others have pointed out, this isn't news in any case.

Come *on*, do some actual reporting one of these days, rather than just surfing the web and complaining about the conspiracy.

Posted by: captain caveman at December 3, 2009 05:27 PM

Steve,
I should add...I was on depakote many years ago...I in fact was on way before it became ragingly popular...

the truth? "cutting edge" docs are the most dangerous because they truly have no idea what the hell they're doing.

Posted by: Gianna at December 3, 2009 06:12 PM

and to finish that thought...the sad part is I knew in my gut what the truth was...and he and his cohorts tried their damndest to get me to ignore what I knew...you don't put toxic crap in your body that does all that it does that you feel day in and day out and think it won't hurt your baby...weight gain, sluggishness, cognitive problems..etc etc...no way was I gonna let a baby incubate in my body under those conditions...

and the docs don't hear that...that's sad

THAT is a mother's instinct and the one I chose to listen to.

Posted by: Gianna at December 3, 2009 06:17 PM

Depakote is more commonly referred to as Valproate here in Australia. A colleague saw a 16 year old girl (erroneously in her opinion diagnosed with bipolar) who gave birth to a baby with severe deformities = "Foetal Valproate Syndrome". I've seen 3 teenage girls all diagnosed bipolar and put on valproate by their family physicians - but on the longer more detailed history taking I can provide as a child psychiatrist - two have no indication at all of bipolar disorder, the third is a very outside chance maybe - and none knew that valproate could cause birth defects. All were sexually active.

It is a big problem and not as well known by doctors as it should be. I recall 15 years ago tackling a drug rep at a conference with questions about polycystic ovarian syndrome and being shown company sponsored research that it did not cause POS.

If birth defects and polycystic ovaries were actually benefits and not adverse events then we know doubt would hear heaps about them over the years from the manufacturers and be well CMEducated.

Posted by: AussieChildPsychiatrist at December 3, 2009 08:35 PM

Thought I’d be a good mom. Luckily I was a good mom and never had those babies.

The best Gianna! The best mom ever.

Posted by: Ana at December 4, 2009 04:28 AM

I took Depakote.
Great drug! It was by the time I was out of Effexor after 19 months in withdrawal hell.
I've been off Effexor for three months. If I was going to numerate all the withdrawal symptoms I felt these days it would take too much time and I would had to go to a memory lane.
I believe that 2 drug-induce suicides attempts can give an idea.
Well, living was impossible.

I went back to Effexor and the psychiatrist, they don't believe that withdrawal is a fact maybe because anecdotal evidence is not taken seriously, in other words, they don't trust patients words. I wonder if they even hear because I have to explain my story from time to time and... I digress.

I felt my back acking like never and... cramps and other stuffs I don't remember.
Fortunately I was able to take this thing out and only told him that I did it.

Lately I fear coming to Furious Seasons.
THINGS ARE GETTING WORSE.

It gives me the impression that they are in a hurry to make more money.
Or is it because Xmas is near and they think that nobody will notice?

Maybe that is the reason.

Posted by: Ana at December 4, 2009 04:41 AM

LOL

StevePHDMD and other titles behaves just like one of them and complains.

Lol

Finally something funny at Furrious Seasons.
I hope you come here more often StevePHDMB and other titles!

Posted by: Ana at December 4, 2009 04:57 AM

Wow!
I just found out the right way to approach a physician:


"How do you do Your Highness?"

"His Highness has prescribed me Depakote, Seroquel and Paxil and told me I can have all the babies I want. I hope I have twins at my first pregnancy."

Posted by: Ana at December 4, 2009 05:00 AM

Depakote and polycystic ovary syndrome can be found all over the neurology information for epilepsy: guidelines say don't put women of reproductive age on Depakote. But in psychiatry, they don't call it an antiepileptic drug, but instead a "mood stabilizer" and use it for whatever they feel like, like they do all drugs.

Posted by: Eileen at December 6, 2009 02:33 PM

"Depakote and polycystic ovary syndrome can be found all over the neurology information for epilepsy: guidelines say don't put women of reproductive age on Depakote. But in psychiatry, they don't call it an antiepileptic drug, but instead a "mood stabilizer" and use it for whatever they feel like, like they do all drugs"

Interesting. I found the same descrepency with Lamictal information. In regards to epilepsy, you'll see things like; "It is well known to cause cognitive impairment and memory problems", for bipolar, never saw that info.

Posted by: Damaged at December 7, 2009 06:44 AM

Damn, Gianna... Medication risks aside, what the hell was your doctor doing butting into your reproductive choices? Nosy fucker.

And SteveBMD... I consider the _majority_ of psychiatrists i've seen to have been incompetent in one way or another; or at least their treatment of me was pretty poor. A good friend of mine has had a similar experience. I'm not about to claim that all psychiatrists are ignorant and corrupt, but i will say that when your odds are as shitty as mine have been, that is a sign that there might be something really wrong with the profession as a whole.

My last two shrinks have been great. And both of them have the same issues with the field of psychiatry as i do, although they're not about to run around shouting it from the rooftops.

I don't think there's a conspiracy, nothing like that. Rather, most of the problems i've had with psychiatrists, i think, stem from understandable, human problems. Not having the time or inclination to get to know and understand their patients. The desire for quick results. Illusions of infallibility. Things like that.

Posted by: Sarah at December 15, 2009 02:55 PM

"I consider the _majority_ of psychiatrists i've seen to have been incompetent in one way or another; or at least their treatment of me was pretty poor."

I've put myself in a psychiatrist's position sometimes, just imagining what it would be like as a job. And you know, it would not be an easy career. First off, the patients tend to be people who are a pain having to deal with in the first place, and in the second, they're often completely ungrateful for the help you do give them.

There should be a psychiatry appreciation day. Just a card and a note letting them know you do appreciate their help efforts.

Posted by: tulipmania at December 16, 2009 09:57 AM

Geez, tulip. Do you think we're idiots?

I actually DO thank the people who help me. Most of us here do have that modicum of manners.

As for helpful people, the many psychiatrists I've seen in the past misdiagnosed 25 years are not amongst them. In fact, I'm lucky to be alive despite their massive incompetence.

I deal with PCPs, auto mechanics, plumbers, accountants, carpenters, attorneys and members of many other occupational groups every day of my life. I have to say psychiatrists, as a group, are the least competent I have ever encountered.

Posted by: Sherry at December 16, 2009 12:50 PM

tulipmania, i am not disagreeing with you that psychiatry isn't an easy profession, and i will agree that a lot of these doctors are doing the best that they can. However, if the best they can do is not very good (and i am claiming that it is not very good), then they need a sabbatical, a new job, or an overhaul of the whole profession. The good doctors i've seen are proof to me that it IS possible (if difficult) to practice good medicine, even in the field of psychiatry.

Again, i think it is precisely those good intentions that makes this a dangerous situation. Let's say i am looking to a person of authority for help. I can sense that that person cares about me, is trying to help me, and is super confident about his knowledge and abilities. That makes me really want to trust him, and that, in turn, puts him in a unique position whereby they could mislead me _despite_ their best intentions. (Sorry for the sexism, but i liked the one female shrink i ever saw... and by the way, please, please someone tell me if i am getting too repetitive with my redundant comments.)

It's the ego, that damned ego, always getting in the way.

I don't think i'm really bitter about the way i was treated -- I've learned from it, and now i do my homework and advocate for myself, as a patient as well as in other aspects of my life -- so much as absolutely furious on behalf of the patients out there who don't even know what piss-poor service they are receiving and wouldn't have the resources to help themselves if they did.

Posted by: Sarah at December 16, 2009 03:59 PM
Post a comment









Remember personal info?






pic1.jpg

Patient Blogs. Sites.
Doctor Blogs. Sites.
Activists. News.
Social Networking. Forums.
Science. Big Pharma. Ethics.
Current Affairs
Seattle Stuff
Smoking. Stuff.

Info
About Furious Seasons
Email
Other Articles
ZYPREXA Documents
Alt ZYPREXA Documents Source
Blakemore-Brown Transcript

 Subscribe in a reader

Search


Recent Entries
$99 Left
$114 To Go
Winter Fundraiser, $134 To Go, Final Day
Ruth Lilly, Eli Lilly Heiress, Prozac Beneficiary Dies At 94
Winter Fundraiser, Final Day, Less Than $200 To Go
UCLA Psychiatrist Criticizes DSM-5
Winter Fundraiser, Barely $200 To Go
Most Popular Posts Of 2009
Winter Fundraiser, Less Than $300 Left, Let's Wrap It Up
Senate Health Care Bill Contains $1.25 Billion Gift To Sen. Stabenow
Travel Day, Comment Approval May Be Intermittent
Winter Fundraiser, Close But Stalled
Senate Health Care Reform Bill Contains Controversial MOTHERS Act, Abortion Study
Adult ADHD And Sleep Problems
Vic Chesnutt Dead At 45, Possible Suicide
Recent Comments

Sarah on FDA Issues Major Birth Defects Warning For Depakote

Sherry on FDA Issues Major Birth Defects Warning For Depakote

tulipmania on FDA Issues Major Birth Defects Warning For Depakote

Sarah on FDA Issues Major Birth Defects Warning For Depakote

Damaged on FDA Issues Major Birth Defects Warning For Depakote

Eileen on FDA Issues Major Birth Defects Warning For Depakote

Ana on FDA Issues Major Birth Defects Warning For Depakote

Ana on FDA Issues Major Birth Defects Warning For Depakote

Ana on FDA Issues Major Birth Defects Warning For Depakote

Ana on FDA Issues Major Birth Defects Warning For Depakote

Archives
December 2009
November 2009
October 2009
September 2009
August 2009
July 2009
June 2009
May 2009
April 2009
March 2009
February 2009
January 2009
December 2008
November 2008
October 2008
September 2008
August 2008
July 2008
June 2008
May 2008
April 2008
March 2008
February 2008
January 2008
December 2007
November 2007
October 2007
September 2007
August 2007
July 2007
June 2007
May 2007
April 2007
March 2007
February 2007
January 2007
December 2006
November 2006
October 2006
September 2006
August 2006
July 2006
June 2006
May 2006
April 2006
March 2006
February 2006
January 2006
December 2005
November 2005
October 2005
September 2005
Resources
Mental Health America
National Alliance on Mental Illness
Depression and Bipolar Support Alliance
National Institute of Mental Health
McMan Web
Powered by
Movable Type 3.2