Bendectin And Birth Defects (Page 16)

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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The fact that you state his children have a 70% chance of having the same problem would indicate that it has nothing to do with the drug but is instead a heritable trait. Duplicate ureters are not that uncommon.

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Is there any recourse for any problems stemming from taking Bendictin? I took it for a month or two for nausea when I was pregnant in the 70's. My son was born seemingly normal but developed learning disabilities. He was diagnosed with ADD during elementary school. I didn't take any medication with my previous 3 pregnancies and those children don't have any signs of ADD or such disabilities.
I would like to know if he could get any compensation. He was unable to complete high school or get a good paying job.

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Sonja, Unlikely that there is any compensation out there for your son having ADHD. There has been no demonstrated association with bendictin. As you may know, ADHD is very common with as many as 5-7% of school age children being diagnosed. There is a genetic link, but more prevalent in boys (you didn't say whether your other children were boys and girls), but still only about about 20-25% of families with one child having ADHD will have another. So statistically it is not surprising that only one of your children would have ADHD and unlikely to be related to the bendictin.

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I have really enjoyed the voices of reason in this discussion. I was googling this drug because my sister-in-law has mentioned how she can never have children because of a drug her mom took while she was pregnant with her. She has many of the issues others mention here, but funny enough, her brother who was not exposed to the drug in utero has many of the other problems people on here mention.

I know several people who have had children with many of the defects mentioned here as caused by this drug who were never exposed to it or any other drug while pregnant.
My son was born with a lip-tie which is more common than people think and was not exposed to this drug. If caught in infancy, you can avoid many speech problems.

I do truly feel for those who suffer with debilitating conditions and I understand about wanting to seek answers. There is talk of them re-introducing this drug and with the evidence mentioned here by emtridoc I think its wonderful that relief will be available to women again. I had to take a different drug while pregnant in order to function and there is always going to be a worry in the back of my mind that there is some effect on my child but it was what I had to do.
My poor mother-in-law is living with the guilt over what the drug did to her daughter when that may be completely unnecessary. I'll be sharing that information with her next chance I get to hopefully offer her some relief over those worries.

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Hi , in no way is Diclectin harmful for the mother and her baby. It is the first line treatment in Canada as per The Society of Obstetricians and Gynaecologists of Canada (SOGC) You can learn more from this link here :
sogc.org/health/pregnancy-nausea_e.asp
and see the latest clinical guideline here:
sogc.org/guidelines/public/120E-CPG-October2002.pdf

Here's a quote from it:
``A recent update of the Briggs’ Drugs in Pregnancy and
Lactation14 revised the monograph of the product, and based
on numerous studies on the safety and effectiveness of the doxylamine/
pyridoxine-dicyclomine combination (previously marketed
as Bendectin®) has changed the risk factor rating to “A,â€
indicating that there is no risk to the fetus``

Diclectin is only sold in Canada as of now , hope it helps.

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In 1982 I was visiting family out of state. I had already had a home pregnancy test and confirmed I was pregnant and knew how far along I should be. One evening I began having severe pain in my abdomen and went to the ER. The Dr. said it was either a tubal pregnancy or I had a cyst and would loose it either way. He prescribed a heavy sedative and pain med. just so I could make it back home to my Dr. The next morning the pain was gone and the throwing up began. I was 6 wks along. By the time I made it to my home Dr. I was throwing up every 15 minutes on the clock, around the clock. I was put on Benedectin, 2 in the morning and 2 at night. Friends would tell me it would pass. I tried to get off of it several times. (5, 6, 8 months) and everytime I would miss a dose, it began again. Took it up until I delivered. Had a healthy 7 lb 9 oz girl with no problems and a natural childbirth. I believe I would have spent alot of time in the hospital without the Benedectin.

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Yes, I know I spelled it wrong, but that is what we called it.

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Ladiebear, I'm delighted your pregnancy turned out ok, but that sure is a scary story: "Well it's either a cyst or a tubal pregnancy"?!? One is a generally benign condition that just needs some pain control, but the other is a life-threatening surgical emergency! If a tubal pregnancy (ectopic) ruptures, the mother can rapidly bleed to death. You can't just be given some sedative to wait it out. Ultrasound wasn't as prevalent in '82, but there were still steps that could be done. I always say better lucky than good, but I'm sure glad that doc was lucky when he flipped a coin!

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I took the drug benedictine 1979-1980 during my pregnancy with my daughter. She is now 32 and was diagnosed in her teens with fybromyalgia and now she has developed many mental issues,OCD, BiPolar, PTSD, depression and suffers severely with muscle and nerve pain. I did not take the Benedictine with my other 2 children and they have none of the same issues she does.

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Janice, I'm very sorry to hear of your daughter's plight.

Ladiebear, re the spelling of your 'Benedectin'. Nil desperandum. "A rose by another other name would smell as swe_etymologically".

It's still my firm belief that certain expectant mothers should not be given particular drugs, including those of Bendectin, Debendox and Diclectin. When one considers the extensive list of side effects [n.b., and a not necessarily exhaustive list at that!] that accompanies each drug it's not difficult at all to infer that taking these drugs is a bit like playing Russian Roulette, or just flipping the aforementioned coin [emtridoc's post #310] which is no less precarious at all in some cases.

Ask yourself this very simple question. How many different drugs have you taken and never had ANY of the many listed side affects? Or only some. I know I've never had ANY of the nasty listed side effects with the many different medications I've been prescribed but plenty of other folk have by all accounts, just like those poor souls who must never have even the slightest amount of peanut, for example, or they could lose their life, as some have done. Peanuts, harmless to many but deadly to some! Yet still a worthwhile livelihood by the same token, as former US President Jimmy Carter from Georgia could attest.

We don't yet know nearly enough about the human body and perhaps never will, maybe if only because of miscegenation which, just like the continual mutation of viruses etc., always keeps just that one [perhaps two] step[s] ahead of research.

Regarding rocketscience's post [#307], even if there is no known risk to the fetus from a particular drug one must never conclusively infer that there never CAN be one[a risk]. Remember too that antivenene used to be the first line of treatment for a venomous snake bite until it was realised that the antivenene was, in some cases, just as likely to kill the patient as was the snake venom per se. The antivenene was then only administered as a LAST [not first] resort iff[sic] it looked like the patient would succumb. We live and learn, and one lesson we can all learn is simply this: The greatest gift, apart from the giving and nuturing of life, that we can give to each other, is to challenge each other's ideas, for they are but simply hypotheses, and nothing else besides. Certainty just hardens attitude...and I firmly belive this. Purely as a soft option of course! Just like a doctor cursorily prescribing something instead of performing a judicious examination when it's manifest that perniciousness could seriously be at stake.

Best regards to one and all from Down Under. We're yet maintaining that vigil.

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Interlineal Peruser - While I do think caution needs to be taken before taking any medication during a pregnancy, I think sometimes the fear of the unknown with medication can be taken so far as to actually cause harm.
Many women will not even take tylenol while pregnant, yet the effects of a fever on a fetus can be devastating. (its possible that some of the unexplained birth defects we see could be caused by infections or fevers during pregnancy)
All medication should be taken with a consideration of the benefits vs. the risks. And if necessary, in consultation with a doctor you trust and your own research from reliable sources.

They recommend the flu vaccination for pregnant women, yet many are so fearful of the vaccination that they never stop to consider what having the flu (particularly H1N1) can do to them while pregnant and the fact that their immune systems are weaker while pregnant. Women HAVE died from the flu while pregnant, and while the effects of a vaccine are still 'unknown', there are no known ill effects aside from the usual risk of vaccine reaction.

And I say this as someone who had to weigh the pros and cons to taking a medication while pregnant that has absolutely no research or data behind it and was recommended not to be taken during pregnancy. It was a gamble and one that was quite stressful for me to take, but my child was born perfectly healthy. It doesn't mean the drug is safe for everyone, or even for me on a future pregnancy, but its a choice I do not regret making.

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Lilipie, you've really hit the heart of the matter: everything we do has a risk/benefit. From getting into car, eating a bowl of sugary cereal, taking a medication, or having open heart surgery, we have to weigh the risk vs. the benefit. ILP has a valid point in that you can never know with certainty how an individual will respond (as in the peanut allergy, where in general peanuts are fine to eat, but for a small percentage deadly). With bendictin the myriad of studies done in a number of ways (and I've referenced several along the way of the many postings in this string) no untoward outcome was bourne out statistically from the use of the medication. In a risk/benefit analysis if you weren't experiencing bad nausea/vomiting then why would you take the medicine - no benefit. But dehydration carries risks and complications so you have to weigh the risks/benefits of dehydration from n/v vs. management options.

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lilipie, I'm glad to hear that your child was born sans any problems. It's surely a blessing indeed.

I acknowledge that you've already said it's a gamble, and it is, but methinks the beginning of your final para in #313 requires some feedback. It's beyond me as to how anyone can veritably weigh the pros and cons of something, be it a drug, or anything else, when, as you said, "...that has absolutely no research or data behind it...".

Moreover, whilst you've made mention of Tylenol, you've both not mentioned what the name of the medication is that you took and the qualification of the person[s] or institution who/that recommended you not take it [the drug] whilst pregnant. Someone else may have also taken the same as yet unmentioned-in-despatches drug whilst pregnant, or not pregnant, and had a similar -- or quite different -- experience with it as did you. Is the drug in question able to be obtained over-the-counter sans a doctor's prescription or is it a 'prescription only' drug, and if so, why would it be prescribed yet recommended not to be taken by you, whilst pregnant, or at any other time perhaps?

The real bugbear of the first water is when -- as I'm sure many folk already know -- a person has to make a vital decision regarding life and limb when they are so seriously ill, and think that they've no recourse but to have to make that decision hurriedly. Well may time and tide be said to wait for no man but that need not universally apply to all else. Who was it that said: "life wasn't meant to be easy"? If said person's name should fortuitously come to light...should we all endeavour to go easy on him? Hardly!

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ILP - I didn't mention my medication since this is a discussion about a different one. The medication in question is provigil (modafinil) which has not been on the market for very long and though is now being used off-label for other conditions, there isn't any information on its effects during pregnancy. Based on the results of some animal studies (mentioned in several drug registry databanks) where the dose was extremely high, there was indication that it could cause fetal abnormalities. That result does not mean that it will have the same problems on humans and different doses may pose different levels of risk, but it does flag the drug as a Class C. Running tests on pregnant women is considered unethical with a class C drug. It is used for the treatment of narcolepsy which I have. Without it I cannot work or drive and would sleep most of the day. Even if I got rides to work and if my employer was ok with me being sleepy and taking some naps at work, the level of fatigue I experience leaves me making constant mistakes. While not a life-threatening condition, I would lose my job and could not afford to keep a roof over my head if I could not work (job-protected leave is a maximum of 16 weeks for pregnancy in my state - which is more than the amount for other medical conditions). I am the primary breadwinner in my family also so the loss of income is greater than it might be in some other situations. So it was not a black & white decision but the alternative medications available to me are amphetamines which are known to not be safe during pregnancy while provigil is a different kind of drug and does not have the same kinds of side effects or addictive properties.

I reached out to every doctor I could see who has experience with the drug, I also spoke to pharmacists and did all the research I could online. I called the California teratogen hotline and asked for all the information they had. The only information available was that during studies of the drug 7 women became pregnant. Information on how long they were on the medication and what dose they were on was not availble. All 7 pregnancies resulted in normal/healthy births.

In discussion with my doctor, I lowered my dose to the lowest amount I needed to function.
They recently have started a registry to track the results of pregnancies where women choose to stay on the medication. I was not included in the registry because my doctor didn't know about it at the time I was pregnant.

I am still nursing my child and I am on the amphetamines now. There is more information available on that medication and breastfeeding indicating that it is not significant enough to affect the child. So in that case, the lower risk to the baby was to take the amphetamines than to stay on the provigil which is a complete unknown. I also time the taking of the amphetamines to hopefully time the feeding during the times when the medication level would be at its lowest in my system as an extra precaution.

Anyway, that is my story and it was a very personal decision that was difficult to make but that is the information you requested.

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lilipie, thanks for your prompt and most comprehensive response. It's most heartening to read that you are doing all that you can to deal with what's before you in life and I wholeheartedly salute you and wish you every success in your endeavours. I have sometimes wondered if I'm a narcoleptic too, but if not, then I reckon I'd be the next best thing c'OZ' I'm never averse to hitting the old "snore-patch" at any time.

I'm wondering if you have a normal melatonin level too. You may wish to record your body temperature throughout the day to see if it fluctuates and particularly if it lowers as you begin to feel tired.

They say it's a small world and I have further proof of this*! --Someone once said: "Stop the world, I want to get off!" The thing is, it's "still" too large, but if it gets any smaller, at worst, it'll only "start" to get p_underfoot, then we'll be but p_unable to ever stop it! --

*I have only just finished [2 days ago] reading a very interesting article by Henry Nicholls, who's a science writer based in London, and a narcoleptic. He developed narcolepsy in his early 20's and he discovered that drug companies are far more interested in inducing narcolepsy than curing it. His article's about narcolepsy, insomnia, orexin receptors/blockers etc. It's in the "NewScientist" magazine [it's online too!] issue #2857, 28 March 2012 [24 March 2012 here in OZ], page 48. Hope it's of some help to you.

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Thank you for your thoughts and for the information. They did several tests before having me go through a sleep study where I was diagnosed. Additionally I have mild cataplexy which goes hand-in-hand with narcolepsy which just confirms the diagnosis. I am very happy with the way provigil helps me manage it, just can't wait to get back on it :)

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I agree that everything under the sun is being blamed on this drug but there was research by a Canadian doctor that established a link between the drug and congenital malformations. This was in 1977. I know this as he is a local doctor and was the main witness at the first trial. My, daughter, now 35, was born with an extremely rare eye deformity which was showing up in babies of mothers who took the drug. She was recently found to have a misshapen uterus, which I see is a common thread on these postings. So, yes things do just happen but often there is a cause and some of the common complaints on this site are likely linked to the drug.

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A very interesting statistic to consider, regarding Thalidomide, is that it's been estimated that embryopathy was found in just 20%* of the pregnancies having exposure to Thalidomide taken during the critical period, being, from the 27th day to the 40th day of gestation. Raising the obvious question, why wasn't there a much greater percentage, or even a total 100% of embryopathy given that it was proved conclusively that Thalidomide was the culprit, never forgetting for a moment that Thalidomide was available for 4 years before its teratogenicity was recognized? This more than merely suggests that many, actually something approaching that of 80% of the expectant mothers who took Thalidomide during the critical period were able to ingest the proven teratogen without its causing at least some type of manifest abnormality -- be it even considered only a minor one in comparison to the myriad other severe ones -- to the fetuses.

A most easily drawn inference from this is that it is not in the least beyond a quite plausible possibility that the same or similar percentage of embryopathy could somewhat apply to pregnancies involving Bendectin, Debendox, Diclectin, and any other drug still -- and even moreso now -- under similar suspicion. Not all mothers who took either Bendectin, Debendox or Diclectin had babies with abnormalities. But this fact alone doesn't prove conclusively that any of the trialled triumvirate is totally innocuous where teratogenicity's concerned. The bottom line of all this is that the aforementioned circa 20%* of expectant mothers should never have been put in a position of being given Thalidomide to ingest and the expectation that it'd do no harm to their babies. Thalidomide was said to have had no recognizable teratogenicity with the rats upon which it was tested. Definitely a veritable chalk and cheese method of testing and vowing that no teratogenicity would be visited upon any humans, just like the above-mentioned bit about the fact that just because many babies had no teratogenic problems with Bendectin and its cousins that folk must forever assume none ever existed. I'm still not convinced so.

Physician Peter Mere Latham once said, "Poisons and medicine are oftentimes the same substance given with different intents." And different dosage, he might have added. Determining the right amount -- neither too much nor too little -- is crucial as the effect of a medicine varies by age, weight, sex etc. [and surely condition too, like being pregnant!]. That's where posology is supposed to come in, but perhaps pernicious paregorics in turn go out...the door!

The source of some of the above can be found under: HUMAN TERATOGENS: A CRITICAL EVALUATION. The Motherisk Program, the Hospital for Sick Children, Toronto, Ontario, Canada.

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Vivian,
I am sorry, of course, for any suffering that you or your child have had to endure. But "mishapen" uterus is not uncommon and the scientific community has come down pretty firmly that there is no association between bendictin and congenital malformations.
While I enjoy the discourse with ILP and there's no denying that we can't predict consistently who will react adversely and in what way to different medications (or strawberries, peanut butter, glutens, or micronutrients in various water supplies), we do know that common things happen commonly (sometimes a relative term) and that the common things listed here do not occur at different rates among women who took bendictin during their pregnancies and those who did not.
A few dozen or even a few hundred who demonstrate a mild trend on this web site don't consitute any evidence of attribution because the tens of thousands of women who have children with malformations, autisim, behavior disorders, etc. who didn't take bendictin wouldn't ordinarily find their way to this site and post that their children were similarly afflicted despite not having taken the drug.
For what it's worth, there is research now occuring into individual protein production (proteomics) that may actually unlock the key to knowing not only who will react adversely to particular medications, but also who will benefit so we don't make blanket recommendations such as taking a daily baby aspirin. I would guess there will be substantial progress in this area within a decade, maybe less.

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Thanks for your reply. I would be happy to know that there is no link between my daughter's condition and the drug I took. However, I beg to differ on your contention that there is no link between congenital malformations and benedictine. As I mentioned before a local doctor published his research which has been accepted as establishing a link between some type of extremely rare malformations and the drug. My daughter's eye deformity is also extremely rare but this particular deformity has not been conclusively linked to benediction. Regardless of whether or not her other deformity is linked or not it certainly taught me a lesson about taking any type of drug (unless really necessary) when pregnant.

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