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Paxil may be linked to birth defects


MomtoGiuliana
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WASHINGTON - The Food and Drug Administration is warning that a study has suggested that the antidepressant Paxil may be associated with birth defects.

Paxil's manufacturer, GlaxoSmithKline, said it will include the results of the study in the drug's list of precautions.

A retrospective study found increased numbers of babies born with birth defects to women who were taking Paxil during the first trimester of pregnancy, as compared with women on other antidepressants, according to the FDA and the company.

This included an increase in heart defects, according to a letter from GlaxoSmithKline to health care professionals. The FDA released the letter Tuesday.

The drug, which goes by the generic name paroxetine, is already classified as a "Category C" drug for pregnant women ? meaning comprehensive studies of its effects on a pregnancy have not been performed.

Doctors are advised "to carefully weigh the potential risks and benefits of using paroxetine therapy in women during pregnancy. It is recommended that health care providers discuss these latest findings ... as well as treatment alternatives, with their patients," GlaxoSmithKline said.

Based on the study, the company said it has not concluded there exists a definite, causal link between the drug and the increased incidence of birth defects. GlaxoSmithKline cited another survey of births that it said does not note a comparable increase.

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When I was 15 or so, a big study was done that decided if you breast fed, your child had a threefold chance of getting cancer. In other words, breast feeding caused cancer.

When I got pregnant with Jake, I was taking a drug that was pulled for causing birth defects. (I was using birth control and not planning on getting preggers) So I knew I was going to have a deformed baby and it would be my fault. On top of that, I had such horrible morning sickness with both of my kids, I took a morning sickness pill that was subsequently pulled because of birth defects. Jake has medical problems, but they are genetic from his father's side.

My point here is, all drugs can cause problems in some people, and you need to weigh the risks. If even one person has any side affect that can be linked in any way to a drug, it must be put in the literature, that's the law. So all they have to do is take it and no matter what actually caused the problem, it must be put in.

All antidepressants are Category C drugs. I have never seen a doctor give these indescriminently (sp) to anyone. But you have to weigh the risks. In the 3 years I worked in an ob/gyn office, the year I worked on a peds floor, and the year I worked in NICU, of the birth defects we saw, none were attributed to meds, all were genetic. Or defects that have been around a lot longer than paxil.

I am in no way saying it's not possible paxil increases the risks of birth defects, I'm just suggesting that taking it is a personal decision, as it may have an enormous impact on quality of life for some people. And I highly reccomend that no one that has a sick child beat themselves up for the rest of their lives over maybe's, what ifs, or mights. My breast fed babies haven't gotten cancer yet. However since it is the 2nd leading cause of death, should I blame breast feeding, or paxil or something I can get a bit of money for if they do?

I take all this information with a bit of a grain of salt, having been in the medical field a very long time, and having seen the settlements people get when something goes wrong and they need to think it has to be somebody's fault in order to deal with it.

I really really don't want to offend anyone, I just don't think people should be terrified of everything, and this is just one more thing. Paxil is only one of a boat load of ssri's and the fact that so many people are on ssri's would skewer the theory that there is an increase in the amount of birth defect babies. The population of people taking ssri's is higher, but maybe the birth defect number hasn't really changed. I feel like like I'm not making the point I want to here, but hopefully people understand. morgan

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Thanks Morgan. I put this up b/c I noticed it was all over the news media this AM and many of us use SSRIs. Often the mainstream news programs are looking for sensational/simplistic headlines and sound bites, as opposed to the nuanced reality. I think this article makes it clear that there is no definitive link. There are other studies that show no suggestion of connection between use of Paxil and birth defects. I agree that the bottom line is that use of SSRIs during pregnancy is something to discuss with your doctor to weigh risks and benefits in your individual case.

I do disagree with one of your statements--I believe that some doctors DO prescribe SSRIs indiscriminantly. As example, I just got off the phone with a friend who's 23-year old daughter is having significant problems with fatigue. Within two minutes of her appt with her GP, he whipped out a prescription for an SSRI. The same thing has happened to me, to my sisters and to many other women I know.

I don't wish to offend or alarm any one either!

Katherine

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Morgan

Great post. I was going to post something similar but you already covered the bases.

Reminds me of the joke that 90% of the people who have been in car wrecks have eaten bread 12 hours before the wreck. Does this mean bread causes car accidents? LOL

In today's world, everybody has an agenda and it is tough to tell fact from fiction, science from junk science, etc.

We need to be aware of the problems of some drugs but in today's world, I have read that aspirin would never pass FDA approval.

But then again, don't get me started on the FDA!!^%$#@!

Didn't mean to digress, Morgan but my swiss cheese brain does that a lot these days.

P.S. See this anti-aspirin site! Kind of a SCAREY site but still, it does contain facts.

http://www.juiceguy.com/ASPIRIN-side-effec...ude-DEATH.shtml

P.S.S. I also think docs hand out TOO MANY scripts for SSRI. They should be monitored or pt told to see a therapist if depression is a big issue. My sleep doc from several years ago, put me on Zoloft...it can help with some sleep disorders though.

Remember, the news today is all about SCARING US. Heck, even animal planet is FULL OF STORIES I can't watch...animal abuse, animal fights, animal cruelty among animals. It's sick what folks call entertainment. As the media will tell you about leading news stories. . "If it bleeds, it leads!"

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Sophia--you are correct that cause and effect are very hard to tease apart even in the most controlled epidemiological studies. Loads and loads of data are needed to start understanding connections -- whether you are talking about medication side-effects, benefits of certain diets, etc. This study is one tiny piece of a large puzzle.

Katherine

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Katherine

In today's world where everybody has an agenda, it's really sad we don't get the TOTAL picture of the story behind medications.

My personal theory is I will not use a drug unless it's been on the market 5 years. OR been in another country for YEARS when approved in the USA.

Yes, some drugs DO cause harm but it is so hard to find out the percentages of what's real, and what is released so the media can whip us into a frenzy.

Whether it's news or weather, I sometimes feel the media's goal is to scare us all into hiding under the family bed with our pets, a blanket, a bottle of water and a can of Spam! lol. Not that I am cynical or anything. ;)

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One of the things that makes evaluating drugs (or anything for that matter)so difficult is while everything has risks - so does doing nothing. For example, birth control pills do cause a small increase in the risk of blood clots but the risk for blood clots is much greater if a woman gets pregnant. Even lifelong abstinence or natural family planning has risks, there is an increase risk of certain gyn ovarian cancers in women who never have children or have never used hormones to suppress ovulation. So lifelong abstinence increases certain cancers (though decrease the risk of cervical cancer). Antidepressants have risks but so does clinical depression - dead woman have dead babies. There are many drugs that have risk in pregnancy. What people fail to take into account is the effect of the untreated illness on the pregnancy. These issues can be very complex and really involve a risk/benefit analysis. It can make managing a pregnant woman with medical problems very difficult.

Louise

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MomtoGiuliana,

Thank you for posting the article. I never would have known about it had you not posted it. It was very thoughtful of you to think of us, and nice of you to post this for us. You have always been so good about keeping us updated. I appreciate your efforts.

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Katherine,

Thanks for posting the info!!

I agree it's a complicated issue and we have to decide for ourselves what's best for our lives and our bodies. I appreciate knowing about the info so at least I can think about these things and research them more myself.

I've learned over the years that it's best to find the study and read the entire nitty gritty. Reminds me of a commercial out right now that makes a statement about how Doctors state they would prescribe X drug to their own families.

The initial questionaire given to physicians to answers asks, "Would you consider prescribing X to a family member who has "said condition"?

Well, just because they would consider it doesn't mean they would or that it's the right drug for them. There's so much $ and politics in our world it makes deciphering information really tough sometimes.

Anyhow, I do appreciate the info Katherine!

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I'm sorry, I don't think I was real clear. I agree that too many doctors are too quick to give a magic pill to shut people up. My comments were directed towards ob/gyns, in which in my experience have not done it as a rule in pregnant women.

I think they as a class of doctors are a little more hesitant. That is not to say i didn't see it, but only in women with a history of severe post partum depression as a preventative or in women who desparately needed something for anxiety or whatever. other wise I agree that many doctors are not especially careful or thoughtful about this. The ones that are, are generally not very popular however, because we are a pill popping nation as a rule. So many people want a quick magic cure for everything and so many docs are willing to do it. It's kind of a two way street at times...morgan

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katherine, thanks for posting. we don't want anything to do to harm our baby's (also because at times it's such a struggle to even get pregnant). i know you meant well and that there might be people around who can use this information. so (on their behalf :lol: ) thanks,

corina :)

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