Bendectin And Birth Defects (Page 23) (Top voted first)

I took this drug in the 1970's while pregnant. Am looking for the side effects to the babies. Drug has been off the market for many years. Not sure on correct spelling. Used for nausea and vomiting during pregnancy. Thank you for any help you can send me. Sincerely, Dana.

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REPORT

Well I hate to throw off a debate of emotion and conjecture with science and logic, but here goes: For starters, of 26 law suits brought against the manufacturer 22 were found for the defendant and the 4 that were for the plantiff were eventually overturned - the manufacturer did not, in fact, pay. But that's hardly evidence one way or another as juries are a crap shoot. But here's some science: From Can Fam Physician Feb 2011 "Long term neurodevelopment of children exposed to maternal nausea/vomiting and diclectin". Conclusion - "No difference in children exposed to diclectin". What was interesting is that the authors note what appears to be a correlation with the degree of nausea/vomiting and improved neuro-cognitive functioning. Reproductive Toxicology Vol 9 1995: Review of extensive literature pertaining to reproductive and teratogenic effects, expert opinions from both plantiff and defense witnesses, epidemiologic studies, animal studies, in vitro studies, basic science studies, review articles, meta analysis, editorials, case reports. Conclusion: "Five-part analysis indicates therapeutic use has no measurable teratogenic effects. Moreover plantiffs experts failed to meet scientific standards that should be expected of knowledgeable scientists." This article is a really good one and goes into some in-depth discussion of statistics which most people posting here simply don't understand. So sorry, but your one doctor on the stand doesn't meet muster. And also sorry to report that with regards to teratogenic effects such as club feet, no drug has had its teratogenic potential studied greater than bendictin and the conclusion of the scientific community is that there is no effect. In fact The American College of Gynecology, The Society of Obstetricians and Gynaecologists of Candada, and the internationally recognized Motherisk Program all currently recommend Vitamin B6 plus doxylamine (the ingredients of bendictin) as first-line therapy for pregnancy related nausea/vomiting.

Now a bit of logic: since bendictin was removed from the market has the prevalence of the teratogenic problems purported to be secondary to the medication decreased? Answer: No Has the prevalence of mental disorders decreased over that same period? Answer: No. In fact mental disease has increased signficantly, though we certainly could debate whether these diseases are more common or simply diagnosed more frequently. Regardless, seems safe to say they are not less common.

So you may choose to blame yourself, but it's not supported by the facts, and I don't think it's helping much.

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It's unlikely that we'll ever know -- unless perhaps some conscientious insider one day blows the whistle -- if any other temporarily-trialled ingredient was ever covertly compounded along with the Pyridoxine, Doxylamine *and/or*[n.b.] Dicyclomine[especially so when Dicyclomine's inclusion was discontinued], the 3 ingredients that originally constituted Bendectin when it was first introduced to the U.S. market in 1956. It's reported that the third ingredient, Dicyclomine, was not omitted from the formulation until 20 years later in 1976 due to its deemed lack of efficacy, making one seriously wonder why it was not only permitted to be included in first placenta..err..first place, but far more importantly, why it took so long for its being found to be considered inefficacious regarding pregnancy nausea, given that Dicyclomine is listed as being a Pregnancy Category B antispasmodic. 20 years is a long time for a prescribed ingredient to finally show itself up as being inefficacious where such a serious ongoing concern as pregnancy nausea then existed and still does no less. It almost seems that they discontinued using dicyclomine because their supply of it dried up unexpectedly rather than they finally, not to mention diligently[sshh], after 20 long years, sussed-out its inefficacy!

I wonder if there exists somewhere -- just gathering cobwebs like old vehicles and sofas in disused barns -- some of the very first batches of not only Bendectin, but also its commercially concocted cousins, being, Debendox, Diclectin, Lenotan and Merbental. The reason I say this is because it's been disclosed that U.S. health regulators were aware in 2002 that steroid treatments from the New England Compounding Center could cause adverse patient reactions, and 10 years later in 2012, news reports of an outbreak of fungal meningitis surfaced and has been tied to the very same Compounding Center. It could have been 20 years again so I suppose things are starting to look up a bit since it's only been a mere 10 years this time around!

Here's an interesting excerpt I found which relates in no small way to the above:

-- In recent years, raw materials are increasingly obtained from foreign suppliers. Large drug companies, which are FDA inspected, must keep careful track of who has handled raw materials, whilst compounding pharmacies, some so large that they resemble commercial manufacturers, are not bound by similar guidelines. In 2011 the FDA was concerned about the suspected use of unapproved Chinese ingredients in an injectable medication used to reduce the risk of premature birth, but they were refused a sample for testing. Instead, the trade group, the International Academy of Compounding Pharmacists, suggested in an email to the compounding pharmacy that they respond to any requests for samples by saying: "We do not compound or distribute 'samples' of any of our prescription medications to anyone." They went on to advise that if the drug was on the premises, a pharmacist should say it was awaiting pickup by a patient.

This doesn't seem to make sense because if the compounding pharmacy states that it doesn't compound anything, then by its own admission it's not a compounding pharmacy. Methinks if the FDA desires samples from any reluctant and recalcitrant compounding pharmacy then they should merely create within their ranks some pseudo patients who will pick up selected samples for analysis, or simply recruit some willing and trustworthy participants from the public. They may well have already undertaken such methods and intend continuing in same vein. I hope so!

If at all possible, a sample of anything ever likely to be deemed pernicious to humans should be obtained and stored away for future reference. There are ways of cutting through red tape -- where the provision of samples are mandatory -- that we must always be wary of, and here's one prime example. A retired hydraulics engineer whom I know told me of the time long ago, just after WWII in fact, when he was working for a very well known aircraft manufacturer in the UK, and on this particular day he was tasked with taking and submitting a sample of a prototypical airframe component to the UK's Dept of Aviation, as was stringently required by law. Unbeknownst to him, given that it was his very first time being tasked with having to transport a component sample the long distance into the city from his company's factory, he was supposed to take two sample pieces of the same component in order that one piece could be tested immediately, if deemed necessary[but rarely ever was in those days], and the other piece kept intact for future reference should the particular aircraft using said component ever come to grief in the future. Because he only took one sample piece of the component with him, which was a stanchion, and upon finally arriving at the Dept's office and being told in no uncertain terms that his single sample was unacceptable as it was a statutory requirement that he provide two pieces, he was then facing the ordeal of having to travel all the way back to the factory to obtain another piece, which he didn't want to do, and his company was wanting to obtain approval on this stanchion as soon as possible, as he well knew. So what did he do? He went to the nearest hardware store, purchased a hacksaw, cut the stanchion very neatly in half, then whilst holding his best poker face, submitted both pieces to a different employee, took receipt of the officially stamped approval, then went on his merry way. I have noticed on the odd occasion that Ron considers himself to be a "cut" above the "rest" ever since his regaling me with that day's little escapa_de'vious!

My mother said that she only took just a few doses of only one lot of prescribed Debendox, and because she didn't like them, she returned the remainder to the pharmacist and told him of her dislike, but she could have quite easily retained the vestige, and probably should have. One can't be too careful sometimes. We know that doctors always tell us to finish the course of prescribed medication, and whilst it is sound advice to do so in one respect, if you ever suffer problems with any medication and can't finish it, then securely retain whatever remains leftover as it may be all you have to easily aid you in adducing evidence in litigation.

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Linda,
How ironic that you state I'm quoting "opinion and articles" and you have "proof" of real people. In fact what you have is anecdote, which is not proof at all and merely coincidence, and what I have quoted is the results from scientific research (and provided the citations) which sometimes is bench science, but in most instances is based on 'real people' which is an analysis of data collected in a rigorous manner (some times more rigorous than others, which is why the research is peer reviewed, reanalyzed, repeated, and subjected to meta-analysis). Beyond the research I cited in my previous post I have also cited the results of many other research studies in several other posts. So you say you want to see the proof yourself and I have provided the citations so you can "see it in black and white". I have also provided many times an explination for why anecdotes do not equal "proof". You can read my previous posts if you're interested in understanding the difference between coincidence and research.

As an aside, are you suggesting all doctors get "kick backs from pharmaceuticals"? That, of course, is simply not true. Sure enough physicians and researchers have received payments from drug companies and lawyers - and so have plaintiff "expert witnesses". The researcher who very famously "proved" immunizations caused birth defects later admitted he falsified his data for monetary gain from the plaintiffs. How ironic that decades after that admission and subsequent demonstration of the safety and efficacy of routine childhood immunizations, people still reference that article (and children suffer preventable disease).
I'm afraid the fact is that you don't want to blame yourself, you want to blame someone else. It's not your fault (I'm presuming you weren't using drugs, alcohol, tobacco, or other known teratogens), but as you yourself point out, children are born with birth defects every day. Statistically, since club foot occurs in about 1 of every 1000 live births, it would be expected that none of your "ancestors" or other children/family members would be born with club foot, yet your daughter would. That's the difference between anecdote and statistics.

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I stumbled upon this because my daughter is dealing with extreme bi polar and other related disorders, I was just wondering what on earth might have contributed to it. I took Bendictine for 5 months in 1973, she was born Feb 1974 and has always had mood swings, since a young child but as an adult has really progressed to a state of suffering. She has three beautiful children all young boys, so as far as I know none have problems, she had none with her reproductive organs as many of you describe. My heart goes out to all these children and moms that wonder like I do, what if something we thought was helping us is what is hurting our kids now.

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emtridoc, No I was not on any other drug. And you refuse to see some things, and just by posting them on here neither makes all thing true or not true, from your point of view or mine. You still did not list any where there is black and white proof, via medical journal, court documents, etc. What do you have on this page for people who have been effected or believe have been effected, either way, from benedctin. Are you just on here to confuse the readers that read this stuff, so they won't believe they are effected. Or have you been (personally) affected by it in any way. If you have then what? It would appear this site is for those effected by it, not those claiming proof it didn't appear to be that way at all. It is neither her or there but I would like to ask this....

If anyone else reads this and you took benedctin.... did you cry, worry, wonder, why you child had problems you couldn't figure out way. And when you found out there was (a slight possibility) it was caused from benedctin you may have in some way blamed yourself. If when you seen this article you felt an inner anger that you couldn't pin point. If you are please reply to this, and say yes I blamed myself or no I didn't. Thanks

emtridoc, You see we mothers that have children that have suffered. We can't go back and analyze it. We can't go back and blame our doctors. My doctor from that time period is dead. But we can keep searching for answers. And if enough people see these articles on bendcitin, they have researched it because they too have that incredible curiosity and intuition that it did something, but we can prove it.... YET! But we ill keep searching for the true answer. And one day it may prove the opposite of what you say is no proof and turn into proof. There are zillions of medications on the market that treat one thing and cause 10 other side effects, but depending on how serious it is most people just up up with the side effects if the initial reason for the medication was justified. Right? Is that what it is. Probably. But we didn't mind it being our side effects of the benedctin. We just feel anger, tears, hatred and bitterness on what it did to our kids. They are more the victims in it than anything else if it is ever proved. Or should I put it as "When it is proved"

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I'm not Erin Brockovich, and PG and E had all the proof they wanted until someone collected the (case load) in (black and white) proof from (((((actual suffers))))) of it, that there actually was a problem.
Does this make sense what I'm getting at. You can round up all the proof from you want of hundreds of studies of past days. This is 2013 not 1987 or such. All I ask is that you consider there is a possibility that it really did affect women, and their babies-- and that if its a cover up there won't be the black and white proof on any book shelf, of the proof that is does affect people. Not people they select to choose from to participate in their studies.

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It seems that even the world-renowned CSIRO has some employees and at least one associate, said to be the driving force behind a decidely dodgy deal, who weren't above telling lies to the multinational pharmaceutical company Novartis about cheap chemicals purchased from China that they tried to pa$$ off as being their own "trade secret" formula. But their lack of common sense/continuing concern for their fellow man has now been well-exposed, as today's [11 Apr 2013] article in WAtoday.com.au explains.

Full marks indeed to ex-CSIRO scientist Dr Gerry Swiegers for doing the right thing by notifying DataTrace way back in March 2010 that injury or death could likely result from counterfeiting attacks on the easily compromised DataTrace product. Shades of Grunenthal's lawyers telling Grunenthal, the maker of Thalidomide, that sales of Thalidomide as an antiemetic could cause irreparable damage to the company's reputation, let alone what the drug did in fact cause to its many victims worldwide. I see that the FDA has approved Diclegis as an antiemetic for pregnancy nausea.

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The Sydney Morning Herald's Economics Editor Ross Gittins' article, **When gut feelings are better than careful analysis**, tells of what happened years ago to a 21-month-old boy after he was admitted to a leading American teaching hospital. If this story is true then it appears that many[but certainly not all] of the doctors who attended this young boy had well and truly lost hold of the intuitive plot that most likely would have enabled them to treat him with all due care, so that he'd at least have been given a charge's chance of recuperating, and survival.

Given that this little boy was seen by a host of "specialists" who did tests on him over a period of 9 weeks before he died, and that they then continued testing at the autopsy hoping to find a hidden cause, nothing in the way of anything conclusive came to light by their reckoning. This leads one to start thinking that if many "specialists" at a leading teaching hospital couldn't find the cause of a very serious ailment within 9 weeks then no-one else could. Now, if it was "too difficult"[read as: "impossible"] for these "specialists" to find the cause of a very serious problem in a 21-month-old boy, how much more difficult would it be to be absolutely certain, beyond all doubt, that an antiemetic drug such as Bendectin *couldn't*[not just statistically *doesn't*] ever cause teratogenicity in fetuses, and not necessarily every fetus, but some? There is, too, always the possibility that the Bendectin ingested by some women prevented the vomiting of something else that was consumed, and this other consumed item per se, or excess of it, was teratogenic in some way. It's well noted that pregnancy nausea, and more particularly, pernicious vomiting, needs be treated, but there's always the chance that something, whatever it may be, resting in the pregnant body's stomach, is better expelled than retained.

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They are bringing Bendectine back, heard it on the news the other night, my mom took it with all 3 pregnancy's I was the 3rd child and I have several medical problems due to the use of Bendectine, first I had Pyloric Stenosis as an infant almost unheard of in female's then at 6 months I had unusual scar tissue grow over and had a 2nd surgery, now 45 years old, I have several issues, Hypothyroidism, Celiac, Allergies (to everything), just to name a few. How can they allow this drug to come back?

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Christine, I'm not aware that bendictine is being brought back, but if it is it's b/c the overwhelming outcomes of the studies on the drug show it does not cause fetal problems. Pyloric stenosis is hardly "unheard" of in female infants, though certainly more common in males. And the more things you try to pin on one thing (hypothyroid, celiac, allergies), the less likely they are related (though I could argue those at least frequently have a common thread in immune disease).
ILP, people die with multiple specialists trying to figure it out routinely. Sometimes b/c of all the specialists, I'm sad to say. How do we know it's not too much sunlight (or not enough) that's caused these problems if we're to take your argument to the logical conclusion?

Linda, Chromium VI and Hinkley/PG&E is a good example, but supports the oppostie of your conclusion - the research demonstrated that the chromium is a carcinogen, but PG&E hid that they were aware and that it was leaking into the water. So the scientific community didn't ignore data or falsify data, PG&E hid it and ignored it. I'm not saying that no ever does bogus studies. It's always a good idea to look at the sponor of any study to have some idea if there's financial gain for a favorable study. Drug company sponored studies are wisely interpreted with eye towards skepticism.

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you can say what you want, I have issues with digestion because after having pyloric stenosis I had adheasions, therefore the just cut it open and I do not digest food normally, you can believe what you want that Bendectine is not responsible but I am the one that lives with this day in and day out.

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And all the people who had/have pyloric stenosis, celiac, allergies, etc, who were not exposed to bendictin? What do you say to them? If it helps you to believe it doesn't matter too much to me. But I suspect that harboring anger doesn't help your digestive troubles.

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EMTRIDOC, You danced around that reply with golden boots on. What I was getting was that,,, yes, I believe much is withheld, by whom at this point is not completely clear. And I believe that not every situation or illness should not be blamed on benedictine. But there is a link it somewhere of what it does cause, other wise people would not feel this way.
We fell it, we are not out to just blame the makers of it, or whine about it. We feel it changed our lives in some way. We want real----up to date studies, done in 2013, by reputable people, scientist, etc to determine further research. Can you give us that? Not just on the medication its self, on the people affected of studies ( all the victims) on each and everyone that took it, that is willing to consent to it.
Which brings me back to a further question that comes to mind.....What have you got in it? You have not stated that you are a suffering victim. What are you on this site for? I can't help but wonder that. Answer that with a simple answer and don't dance around it like all the other answers. Or can you? Are they paying you to discourage the people that have questions about it? Please assure me you are legit to be on this site, or do you work for them? As for Benedictine cover ups, most importantly, with your negative answers, I believe that people like you are put on here to keep the curiosity down for the victims so that they do not add the proverbial 2 + 2 and figure out that things do not add up to the usual 4.
You can say no one is paying you to do this, but to those on here surely with reading all your discouraging replies, would wonder who would take as much of their free time to discourage others on a site like this unless they had an advantage in it some where for themselves. You clearly do make some interesting points, but we feel it, we see our kids different and we sense something, but we can't as yet prove it. And every where we turn people that tell us we are wrong only enlightens the fact to us we are in a victim situation with this drug. How do you explain that or will that be a reply you will again twist the answer.

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You said that perfectly that is why I didn't bother to reply to her... I feel this person has a vested interest and is on here to discourage negative feedback.

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Thanks Jo Ann.

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Emtridoc,
Clearly your thinking is just one sided, and having not experienced any of it personally all you have is science that you list and maybe truly believe it. So be it. I'm done. I owe you nothing. I owe you no explanations. But when the proof comes out some day, and it will, that it did cause problems and you have all this time chose not to take their part. What will you do then?

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I have just read your thread and would like to let you know that I took debendox for a month to help horrific morning sickness and my eldest daughter born from this pregnancy has not been able to have children even having had five attempts with IVF.

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I to had a child in 1968 born with birth defects after taking the same morning sickness meds as the reast of you and found there was a class action case decided already and that it contains monies to help these children with the many hospital bills they would amass.

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i read your topic about benedictine and what is wrong with your daughters. I too took Benedictine in 1982 and my daughter has a double uterus and has had several miscarrages, where you able to find out anything helpful?

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There's an interesting article online called: "Danish researchers expose new cause of life-threatening disease, 6 June 2013." Apart from diseases, the article mentions fetal development and birth defects etc., and this new research just might be the key to the unlocking of sought secrets explaining exactly the method by which many drugs[inter alia] are easily able to unduly affect not only fetuses, but developing children and adults to boot.

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