Bendectin returns?

The March of Dimes announced recently that Bendectin was making a comeback.

You may remember Bendectin, a morning sickness drug widely administered to pregnant women from 1956 to 1983.

Bendectin treats the most common unpleasant pregnancy complication, nausea, affecting up to 80% of pregnant women. By 1980, between 10 and 25% of pregnant women were taking Bendectin.  In 1983, Merrill Dow Pharmaceuticals withdrew the drug from the market due to an overwhelming number of lawsuits claiming Bendectin caused birth defects. The most famous of these is unquestionably Daubert v. Merrell Dow Pharmaceuticals, Inc. (1993) 509 U.S. 579, 113 S.Ct. 2786, 125 L.Ed.2d 469.  In Daubert, plaintiffs alleged Bendectin caused birth defects. Merrell Dow moved for summary judgment, submitting an affidavit from an expert epidemiologist, Dr. Lamm, who stated that none of the 30 pertinent published studies had ever found Bendectin capable of causing malformations in fetuses. Rather than directly contest Dr. Lamm's factual statements, plaintiffs responded with their own experts' declarations to the effect that their unpublished studies, and reanalyses of published studies, indicated a link between Bendectin and fetal malformation.

Plaintiffs, in short, practiced Junk Science.

The motion was granted, and on appeal, the Ninth Circuit Court of Appeals ruled that expert opinion based on methodology diverging "significantly from the procedures accepted by recognized authorities in the field ... cannot be shown to be 'generally accepted as a reliable technique,' ..." (Id. at p. 1130.) The Court of Appeals rejected plaintiffs' reanalyses as "unpublished, not subjected to the normal peer review process and generated solely for use in litigation." (Id. at p. 1131, fn. omitted.) [Emphasis added.]

I cannot imagine how an attorney could ethically prepare a “study” solely for use in litigation. Ultimately, the Supreme Court issued its landmark ruling, cited above, making federal judges "the gatekeepers" with a responibility of keeping "junk science" out of the courtroom. Nevertheless, it was too late for bendectin and millions of woem needlessly worried and many were deprived of a useful anti nausea medicaiton based on shoddy research aimed at winnign a alwsuit, not in determining the truth.

Now, a Canadian Company plans to market a drug with the same ingredients as Bendectin, to be called Diclectin. By now, there is a large body of research showing that there is no connection between Bendectin and birth defects. Unfortunately, doctors are reluctant to invite lawsuits by prescribing a drug that even has the underserved reputation of causing birth defects. I don’t blame them, but, in the meantime we lose an important tool in improving our quality of life. Certainly, in this case, more harm than good was done.  I object to junk science because its use has harmful consequences that should have been avoided.

Comments

[Sapphire]

My mother took Bendectin while pregnant with me. I have no obvious defects.

Note I said obvious. The defects I do have are subtle, and did not become noticable until later. Slight malformation of the pelvis that only became an issue when I began walking. Subtle heart abnormalities that were not caught until my adult life and I was examined by a cardiologist. Very narrow and highly arched palate that didn't become an issue until I was a teenager and a candidate for orthodontia.

I believe they need to look beyond the obvious defects, like missing limbs, and look deeper into the subtler effects of the drug.

If Bendectin DOES make it back to the market, I'll be sure to warn my daughters away from it.

[tamika conner]

My mother took Benedectin while pregnant with me. I have a condition where my right foot and calf or larger than the other. I have had surgery to make it possible to where the same size shoe. It is noticeable and it has caused alot of heartache in my life! I hope that they do not put this drug back on the market.

[Debbie]

Has anyone done any long-term follow-up from Bendectin usage for psychological defects, such as ADD and ADHD in children?

How about other abnormalities such as anorexia, bulemia, tendency toward obsessive compulsive disease, drug abuse???

Have studies been done concerning long-term effect of bendectin on any of these issues in children??

[Cliff danville]

After taking Bendectin, our daughter is obsessive compulsive. Now, her son has Ashburgher's (a form of autism). There may be a link to these two conditions in a defect on the chromosome 17. It may be a stretch, but could bendectin use have turn on the expression of this gene in multiple generations?

[Lynn Houghton]

I took Benedectin in 1979-1980 for morning sickness. My son is Hearing Impaired, bi-lateral sensory neural nerve loss. It started out as mild I didn't know until he was 18 mths., but it has progressed to severe. I searched through University of Michigan's Genetics before I had another child they could not find it in either of our familes,and gave me a less than -1% chance it vwould repeat. I can go back 5 generations, I searched anitiotics, etc. etc., and could not find any other reason but this drug Benedectin. I had another child 6 years later whose hearing is normal, AND I DID NOT TAKE BENEDECTIN with this second child.
While I was at Constance Brown,in Kalamazoo Michigan, a Hearing Impaired place, I asked each mother that had a HI child there this was in the 1980's; if they took any drugs during pregnancy and ALL of them said BENEDECTIN. This company knows what it does, thats why they changed the name and waited 26 YEARS to remarket it in a DIFFERENT COUNTRY. They never have fought to get it back into the US market. We need to take a stand against, zygote, embryo, fetus, baby hurters like this company Anyone interested contact me at [email protected] I know we can do something if we all get together. I do not want more Babies in Canada to wind up the same way, for their blood stained profits.

[Carrie Stull]

My mother took Bencedtin with both my brother and myself. As I've heard from several other people, our issues didnt surface until later in life. My brother has very weak muscles in his shoulders and had had surgery for this several times, as well as malformed vertebrae. My 4th toe on each foot quit growing when I was in 3rd grade and now it looks like my pinky toe and 4th toe changed places. I also have no middle joint in that toe. My toes were completely normal looking until 3rd grade.

[Jan G.]

My mother took Bendectin with 3 of her pregnancies. We are in our 30's now and have never had any health issues. By the time my mother got pregnant the 4th time, Bendectin had been taken off of the market. That pregnancy was the only one where there were health concerns for the baby. He was born with minor problems that corrected themselves as he grew. Women can't always find a reason for why their child is born with defects, God just allows these things to happen sometimes. To say that Bendectin caused all these problems in babies is ridiculous. Why are babies still being born with abnormalites when women are no longer taking the drug?

[JoAnne Peck]

I took Bendectin when I was pregnant for my first child back in 1982. My daughter was born with a dislocatable hip. She had to wear a brace for the first three months.
My daughter recently at 10 weeks pregnant found out that she has a bicoruate uterus ( heart shape uterus that didn't form right.) making her a high risk pregnancy. At 12 weeks she miscarriage.
Taking this drug could have done this to her uterus.
Keep this drug off the market!!!!!!!

[Carey]

My mother took Bendectin with all four of her pregnancies. None of us have any health concerns or issues. I agree with the comment above. Children have been born with health issues since the beginning of time. Since it's been off the market for many years, who have we been blaming for those health issues lately? Anything you take can be a risk. Getting in your car and driving down to the corner store for milk can be a risk, but we still do it. Why blame a drug, that's so simple you can make it out of Vitamin B-6 and 1/2 a Unisom. Let's all grow up and get real.

[chuck]

The normal distribution for birth abnormalities due to chance is 3% according to CDC. Unless the published safety reports of Benedectin demonstrates a statistically significant percentage greater than 3% of the children associated with moms' taking Benedectin (Which is not the case), Benedectin has far more benefits than risks.

[Jean M]

I took Bendectin for my only daughter and it saved my life and health. My daughter has had no problems other than being overweight, as many young people are today because of what they eat. She, on the other hand, did not have access to this drug when she was pregnant and lost 30 pounds due to continued nausea and vomiting, leading to pre-eclampsia and an induced labor. Her child has had difficulties keeping food down and is slow in developing speech. I have to wonder if the malnutrition caused by maternal vomiting has damaged this child far more than taking Bendectin would have. My OB told me when they took Bendectin off the market that it was a terrible mistake, that he had never even seen any of the supposed malformations that patients were claiming were due to the drug.

[Doris]

I took Bendectin for my first pregnancy. I needed 3 pills per day. I would not have been able to function otherwise; might have lost my job. I lost weight during the first 5 months I was so sick (nausea). I stopped after 5th month. Without it the fetus would have had poor nutrition in the beginning. My daughter has no defects; perhaps some heart palpitations only. She has had a child without incident, a perfect daughter. Then it was taken off the market and my next pregnancy I was sick, and unhappy.

[Meredith S]

I cannot believe the leap described in previous postings for every kind of defect in the book! I took Bendectin with all 3 pregnancies, and my children are fine! It's amazing how we'll look for anything to blame. It kept me from being sick for six months with my 3rd child, and it saved me from great misery in all 3 pregnancies! We've got more health issues now than we ever had when Bendectin was being used. I wish my daughter could take it for her pregnancy now!

[Meredith S]

I cannot believe the leap described in previous postings for every kind of defect in the book! I took Bendectin with all 3 pregnancies, and my children are fine! It's amazing how we'll look for anything to blame. It kept me from being sick for six months with my 3rd child, and it saved me from great misery in all 3 pregnancies! We've got more health issues now than we ever had when Bendectin was being used. I wish my daughter could take it for her pregnancy now!

[Deena]

I took Bendictin with my first child in 1979-80. I took compazine with my second child 1985-86 and nothing with my third child 1988-89. I had horrible morning sickness with all three. My 27 year old daughter is now pregnant. Could there be any dangers to her unborn child because I took this drug?????

[Lynne]

I took Bendectin with my second pregnancy in 1976/78. My daughter is very normal. She developed Chrones Disease when she was in her early 20's, which my husband also has. At the time, we were not aware that it could be passed on to children. I have a son with no health issues. My daughter just had her second miscarriage (the first at 5 1/2 months and the second at 10 1/2 weeks). Could my taking Bendectin be causing her to miscarry?

[sharan]

I took Bendectin with 2 out 3 of my pregnancies. My first child born with food allergies and Asthma. Second pregnancy, I took it for a little more a month and she born with no food allergy but has asthma and extra vertrbrae. Third pregnancy was in 1993, no Bendectin, he was born with no asthma but developed later. No food allgergy All my children has slight problem with corneas. Is this because of the Bendectin??

[Deanna]

I took Benedectin with my son and daughter all nine months, 24 hours a day. I could not get out of bed without it and I had to work as well as finish college. My son is 32 and seems to not have problems. However, my daughter is 30 and was born with WPW, a heart condition for which she had two ablations by the time she was 15 years old. We were told it is hereditary but aboslutely no one in our family history has this or anything like it. She has also had many female problems since she was nine to ten years old and severe pain since giving birth to her two children ages 5 and 3. Her hips hurt so badly she can hardly function from the pain at times. This has not been able to be diagnosed.

I have always wondered if her heart condition was due to me taking benedectin.

[Sheryl]

I took Bendectin in 1977 while pregnant for my oldest son, who had severe problems with ear infections and febrile seizures as a toddler, leading to having his tonsils and adnoids removed and tubes put in his ears at 5 years old. Now at age 30, still having problems with his ears and complaining of having a problem with his jaw and balance issues, the dentist informs him of a malformed jaw and teeth. This prompts me to believe that this Bendectin caused this. I was 20 years old when pregnant, in excellent health and no family history, either side, of anything remotely resembling these issues. My second son, now 17, has had none of these issues and I did not take Bendectin for him. Is it so far fetched that any type of "drug" we put in our bodies can cause "defects" whether or not science can prove it? It's like being allergic to chocolate, or anything else, and the next person not. Human chemistry cannot be explained when it comes to this. Some things just are.

[Niall MacKenzie]

My mother took Debendox (UK name for Bendectin) during pregnancy only with me, not my two elder brothers. They had no birth defects but I was born with Talipes (turned in feet) and a hole in my heart. It could just be coincidence but the odds against all of these cases being coincidences must be pretty high. Obviously science and law suits are always going to be on the manufacturer's side - proving anything beyond reasonable doubt is pretty difficult as several recent high profile court cases have shown....

[Sheila Bryan]

I took Bendectin with my oldest in 1980, and my other two children I did not. My oldest, in her todler years needed leg braces and today just got through with open heart surgery she almost lost her life with and her back is so bad they have told her it is a miracle she is walking. My other two children are healthy. If I would have known that Bendectin was going to do this i would have rathered been hospitialized for the duration of the pregnancy. She is always in pain, always needing to have pain meds, it angers me that this could have all been prevented. I will pray long and hard that they re-think bringing this drug back on the market.

[Marlene]

I took Bendectin with my 1st pregnancy in 1980. My son was born missing his major pectoral muscle causing his chest to appear caved in. As he grew older we also noticied his hand on that side was smaller and webbed. When he became a teen he had to have surgery on his hand to remove the webbing and because the ligaments in his fingers were malformed. The only drug I took during my pregancy was Bendectin.

[lawrence ansell]

My mother took this drug too for me and my sister. Not for my brother and other sister.

My sister and I both have depressive problems, throughout teen years I had severe obsessive compulsive disorder that affected study, leaving me only with a 2:2 in my degree. I was also born with a deformed nose that needed surgury, and apparently have something called a social communicative problem whatever that is? My sister has bipolar. Drug companies are evil sons of bitches who really care only for their own profits. This seems to be the world we live in. Still what is a body, this vessel, I, am me.

[Lynn]

Can someone please confirm the description of this drug? I found a bottle from 1972 that was issued to my mother for nausea during pregnancy. The bottle is not marked with the drug name. They are round white pills with no imprints on them. Does this sound like Bendectin?

[Lynn Ritchey]

I have 4 kids. I took Bendectin in 1981. My Son was born with a "curved" right foot which eventually corrected itself. But what was most alarming to me were the nightmares he had until he was 5 years old, the obsessive compulsive disorder, learning diabilities, depression and behavioral problems in his teen years. (He was in rehab for three years 13-16)he has since become a wonderful, intelligent caring, handsome man, but all this makes me wonder, if I had just stuck it out with the morning sickness, would he have been subjected to all the hell he's had to go through. I had no other problems with any of my other kids.