Medication Alert

September 29, 2005 7:02 AM

This is not good news. U.S. health officials have issued a warning about possible birth defects in infants born to women who take the antidepressant Paxil during the first trimester of pregnancy.
posted by lilboo (38 comments total)

What's the actual risk? 1 in 10? 1 in 1000?

The article says 50% higher then the general population, which dosn't seem to bad.
posted by delmoi at 7:10 AM on September 29, 2005

Don't feed the Tom Cruise
posted by poppo at 7:10 AM on September 29, 2005

Sound familiar?
posted by atrazine at 7:11 AM on September 29, 2005

atrazine writes "Sound familiar?"

Thalidomide? Give me a break. Hysterical much?
posted by OmieWise at 7:13 AM on September 29, 2005 [1 favorite]

Thalidomide is a pretty different case, atrazine. If Paxil kept some women from suicide during or after their pregnancies, then on balance the increased risk might have been worth it to some of them. As I understand it, Thalidomide was used to combat normal morning sickness, and the defects it produced were much more severe than the ones Paxil is producing.
posted by footnote at 7:16 AM on September 29, 2005

This is not good news: it's great news for the medical malpractice industry.
posted by three blind mice at 7:16 AM on September 29, 2005

The solution to the potential stress of squeezing out a mutant being, of course, more Paxil™. Win win!
posted by stavrosthewonderchicken at 7:24 AM on September 29, 2005

Thalidomide is a pretty different case, atrazine. If Paxil kept some women from suicide during or after their pregnancies, then on balance the increased risk might have been worth it to some of them. As I understand it, Thalidomide was used to combat normal morning sickness, and the defects it produced were much more severe than the ones Paxil is producing.

Well the way GPs in the UK hand out anti-depressants like sweets to people even for mild depression, I think the "some" in your statement needs to be emphasised.
posted by FieldingGoodney at 7:28 AM on September 29, 2005

This one earns a great big shrug from me. Exactly how many FDA-approved prescription medications say "Do not take if you are pregnant"? So, yeah. Expect a few lawsuits and a change in the warning label, but otherwise... whatever.
posted by Faint of Butt at 7:29 AM on September 29, 2005

The point I was making is that it's rarely a good idea to prescribe any medication that isn't *strictly* neccesary during pregnancy.
I take your point though that Paxil's benefits are significantly greater than those of Thalidomide, so the cost/benefit would be very different.
posted by atrazine at 7:29 AM on September 29, 2005

My point is actually that the chances of birth defects appear to be significantly less. I disagree with footnote, in that, although depression needs to be treated and treated seriously, the recent meta-reviews of studies have prompted the FDA to suggest that suicidality can be a side-effect of the medications, and in any case, is not directly decreased by SSRIs. (As is indicated in the article: "And last year, reports of suicidal thinking among adolescents using SSRIs led to the FDA ordering a "black box" warning be placed on SSRI labels.") Recent black box FDA warnings suggest that SSRIs are perhaps not an appropriate first-line treatment for depression. There was a recent BMJ article and editorial to this effect. I only bring this up because I think that this is not a cost-benefit issue, and shouldn't be seen as one, but neither does it appear to be of the severity and scope of the thalidomide problems. I didn't mean to be snarky above.

Here are some of the relevant paragraphs from the article:

That analysis found about double the risk of general birth defects in Paxil compared to other antidepressants, when taken in the first trimester. The prevalence of birth defects as a whole among infants born to women in this group was 4 percent, or 43.6 per 1,000 births.

The risk for cardiovascular defects was slightly more than double. The more common of these were ventricular septal defects, where one or more holes are present in the muscular wall separating the right and left ventricles of the heart. This is the most common congenital heart defect.

The overall rate of birth defects in the general population is about 3 percent, and the rate of heart defects about 1 percent. The overall rate among infants of women taking Paxil in the first trimester was about 4 percent and, for women taking other antidepressants during this time, about 2 percent. "I wished I had an explanation," Rhyne said of the discrepancy.

posted by OmieWise at 7:45 AM on September 29, 2005

Just don't take any medicines during pregnancy if you can help it. Don't smoke, don't drink, keep yourself from chemical contact as much as possible, but do make sure you get enough Folic Acid. If you need these medicines to survive then it is different. There is so much we do not know that it just isn't worth the risk. What we do know is that the developing fetus is particularly susceptible to a wide array of foreign substances. We lack good information on which ones are safe and which ones are not, so to be safe avoid them all if you can. This applies to more than just anti-depressant medications. If you are taking any anti-depressant medication I think you have to ask yourself how badly you need it while trying to get pregnant. If you suffer from mild depression perhaps you should go off the meds. If you suffer from major depression and suicidal thoughts I would think you would want to stay on the meds. I certainly would be leary about going off blood pressure medication etc. Remember that many doctors also lack good data here and also have their own biases. This is a decision for Mom to make, with help from her doctor, and it isn't always easy. The good news is that despite the risks, most babies turn out just fine despite exposure to some smoking, alcohol and medication. However, why risk it if you can avoid it?
posted by caddis at 7:51 AM on September 29, 2005

I think the real issue is now requiring birth control for everyone who takes Paxil, just like they do with Accutane. Deciding to go off meds in order to get pregnant is basically academic at this point, but it's the unplanned pregnancies that you have to worry about. Especially since you can be well into the first trimester before you even know that you are pregnant.
posted by lilboo at 8:15 AM on September 29, 2005

It was just a few flipper babies!
posted by maxsparber at 8:17 AM on September 29, 2005

If only we had some kind of Food and Drug... oh, I don't know... Administration of some kind... that could competently test and report the risks of new drugs in a non-political, objective manner. Well, I guess the profits of large pharmaceutical corporations is paramount, after all. Let the public health beta testing continue.
posted by squirrel at 8:32 AM on September 29, 2005

More like alpha testing!..Bazing!
posted by dwordle at 8:52 AM on September 29, 2005

Seriously though, this is horrible news.
posted by dwordle at 8:53 AM on September 29, 2005

what caddis said......
posted by FieldingGoodney at 8:57 AM on September 29, 2005

No, this is good news - there is a small possibility of risk, and now we know about it, and pregnant women can be counselled to avoid Paxil.

We take risks all the time - driving in a car is probably one of the most dangerous we do in daily life but we decide the need to go to the grocery store outweighs the risk. This just gives us more info needed to take intelligent risks.
posted by selfmedicating at 9:02 AM on September 29, 2005

Wait a minute. . . the same study found that infants of women taking other antidepressants are at lower risk of birth defects than the general population?
Ok, I'm not taking this too seriously.
In addition, a previous analysis of the same data found no difference in risk.
This just needs further study.
posted by Zetetics at 9:05 AM on September 29, 2005

This is a decision for Mom to make, with help from her doctor, and it isn't always easy.

Mom and doc need help from science, though, wouldn't you agree, caddis? This ain't Norman Rockwell's America anymore. Doctors don't put band-aids on dollies, they prescribe potentially lethal medications, usually with strong incentives to do so. The current stampede of pharmaceutical lobbying and, frankly, bribery has created a climate where the science community isn't serving and protecting citizens so much as it is serving and protecting Pharmco's shareholders.
posted by squirrel at 9:07 AM on September 29, 2005

If only we had some kind of Food and Drug... oh, I don't know... Administration of some kind... that could competently test and report the risks of new drugs in a non-political, objective manner. Well, I guess the profits of large pharmaceutical corporations is paramount, after all. Let the public health beta testing continue.

Yeah, okay. If you were the head of this "administration" what sort of experiments would you conduct to find out if the drug had a 50% increase in the probability of causing birth defects?
posted by delmoi at 9:26 AM on September 29, 2005

Wait a minute. . . the same study found that infants of women taking other antidepressants are at lower risk of birth defects than the general population?
Ok, I'm not taking this too seriously.

Well, maybe stress causes birth defects?
posted by delmoi at 9:27 AM on September 29, 2005

Well, maybe stress causes birth defects?
Excellent hypothesis.
posted by caddis at 9:30 AM on September 29, 2005

I would certainly like to see the margin of error in these studies.
posted by IronLizard at 9:36 AM on September 29, 2005

Paxil is evil.
posted by kuatto at 9:39 AM on September 29, 2005

Soon you'll see that general population is something so vague and ample you can stretch that collection size depending on what company interest you're not paid enough to protect against people expecting somebody to take responsability.
posted by elpapacito at 9:54 AM on September 29, 2005

Well, maybe stress causes birth defects?

Yes, there is evidence that it does. I suppose, given this study, that we should be prescribing other antidepressants to all pregnant women. I wonder why that isn't the headline?

The language in the linked article is very restrained. I'm particularly fond of this quote, "One cannot deny with absolute certainty that there's nothing related to Paxil and an increased risk of malformations, but we don't have a truly controlled population,"
That's a scientist's way of saying, don't take this too seriously.
posted by Zetetics at 9:54 AM on September 29, 2005

Maybe Paxil is on its way to becoming the next Vioxx?

Seriously, it's extremely addictive and has severe withdrawal symptoms for those who decide to stop taking it (oh sorry docs, it's "discontinuation syndrome"... whatever), may cause birth defects, and may also cause bruxism so bad that your teeth may require reconstructive work if you take it for a long period of time. My dentist was certainly asking why the edges of my teeth had been ground down to that extent.

Frankly, Paxil seems to have all the signs of a drug that just shouldn't have been approved.
posted by clevershark at 10:13 AM on September 29, 2005

Paxil helped me pull back from an awful place.

Should we put up a scoreboard?
posted by gnomeloaf at 10:18 AM on September 29, 2005

My first instinct was to think, "more information is always good." But thinking this through, I don't know. At what point is there too much information for a pregnant woman to decide? "We'll we can start you on Pill A for those suicidal thoughts, but that has been shown to have a small but signifigant increase in birth defects so we can go with pill B, but it doesn't work quite as well and it has been shown to cause sleeplessness which we can counteract with pill BB or we can use pill C which can cause elevated blood pressure in some patients which could lead to an elevated risk for a stroke..." and so on.

Modern medicine can be both a blessing and a pain in the neck.
posted by Secret Life of Gravy at 10:49 AM on September 29, 2005

My first instinct was to think, "more information is always good." But thinking this through, I don't know.

You've got to be kidding.
posted by Kwantsar at 11:57 AM on September 29, 2005

clevershark: damn my naivety I tought no drug (except street drug, so to say) could be marketed if addictive ?

You're breaking news to me :o
posted by elpapacito at 12:06 PM on September 29, 2005

My first instinct was to think, "more information is always good." But thinking this through, I don't know.

You've got to be kidding.
posted by Kwantsar at 2:57 PM EST

Ok, I will back down a bit. It is good that this information was discovered and the doctors can take it into consideration when writing prescriptions. But I see this as complicating the decision making process which more and more is being turned over to the patient.

We see this right now with elderly patients needing liasons to assist them in deciding which medications to take. One pill make cost a fraction of the price of another but needs to be taken twice as often and in conjunction with a different pill. Cost effectiveness. Pill interactions. Side effects. Information overload.
posted by Secret Life of Gravy at 1:23 PM on September 29, 2005

I tought no drug (except street drug, so to say) could be marketed if addictive ?

Google "celebrity painkiller addiction"
posted by Sparx at 3:28 PM on September 29, 2005

You say information overload, I say well infomed patient.

I'll be godammed if I'll put into my body any chemical that I don't know as much as I can possibly know about it.
posted by Specklet at 3:31 PM on September 29, 2005

elpapacito writes "clevershark: damn my naivety I tought no drug (except street drug, so to say) could be marketed if addictive ?"

That's why doctors who prescribe it will insist to you that it has no withdrawal symptoms, and use the term "discontinuation syndrome" to describe the paranoia, loss of equilibrium, light-headedness and auditory hallucinations you experience after you stop taking Paxil.
posted by clevershark at 4:55 PM on September 29, 2005

You say information overload, I say well informed patient. I'll be godammed if I'll put into my body any chemical that I don't know as much as I can possibly know about it.
posted by Specklet

And lordy, how doctors hate it when you come in fully armed with medical data, or you say things like "Ok, I'll take the prescription, but I'd like to do a little research on it before I fill it, then if I'm not comfortable with what I find, may I call you and discuss alternatives?"

It's how I stayed off Vioxx. I've had doctors try to prescribe Wellbutrin about a dozen times, despite the fact that I tell them that giving me SSRIs will make me psychotic. (Really, clinically, dangerously, psychotic. Serial killer psychotic.) They offer anti-depressants like candy to people who don't meet any of the criteria for depression.

My opinion, if they would just legalize pot, many people's problems would be solved...but there's no money in a drug that grows wild and free...so it'll never happen.
posted by dejah420 at 1:06 PM on September 30, 2005