anti-nausea drug banned in 80's

[marje]

I'm looking for the name of the drug that was prescribed for anti-nausea in pregnancy in the 70's and 80's that was subsequently banned because of problems it would cause female children.  Also any information about the effects to the child (22)attempting pregnancy.

[Still_AndiJ]

My mother took that same med while pg with me and while we do not know if it had anything to do with my issues, I have had 4 m/c and 2 successful pregnancies. I will do some looking and see what I can find. I will post the results on this thread.


Andrea

[Still_AndiJ]

The med was called Bendectin. Here is a little blip I found on www.babycenter.com:

You may have also heard of Bendectin (which combines an antihistamine with vitamin B6). This drug was once widely used in the United States to treat morning sickness, but controversy over its safety during pregnancy — despite no scientific evidence that it was harmful — forced the company to pull it from the market. (These days, it's only available in Canada under the name Dicletin.) The FDA has now classified the combination of ingredients in Bendectin (doxylamine and vitamin B6) as "safe and effective for nausea and vomiting of pregnancy" and you can buy both ingredients over the counter. Doxylamine is available as a sleeping pill (under the brand name Unisom Nighttime Sleep-Aid; be sure you don't get Maximum Strength Unisom SleepGels because that's a different product). And you can find vitamin B6 in the vitamin section, of course. Ask your doctor or midwife if this combination would work for you and, if so, what dose you should take. Remember: Never take any drugs, vitamins, or herbal supplements during pregnancy without first talking to your practitioner.

Here is the web address as copied from my browser:
http://www.babycenter.com/expert/pregnancy/isitsafe/1366869.html

***And here is an article from the March of Dimes: ***

Bendectin Making a Comeback

Nausea and vomiting of pregnancy is the most common condition in pregnancy and affects up to 80 percent of all pregnant women. Prior to its withdrawal in 1983 the morning sickness drug Bendectin was widely used throughout the world to treat nausea and vomiting in pregnancy. Its original three active ingredients were doxylamine succinate (an antihistamine), dicyclomine (an antispasmodic), and pyridoxine (vitamin B6). Bendectin was first marketed in the U.S. in 1956, and it is estimated that the drug was used in 33 million pregnancies by 1983.

By 1980, ten to twenty-five percent of pregnant women in the U.S. took Bendectin.  This changed in June 1983, when Merrell Dow Pharmaceuticals voluntarily withdrew the drug from market because of an overwhelming number of lawsuits claiming that the drug caused birth defects.

Now a small Canadian company (Duchesnay Inc.) is working with the U.S. Food and Drug Administration to obtain permission to market a drug with the same ingredients that Bendectin contained from 1977 on (doxylamine and pyridoxine), which they call Diclectin. Diclectin is already being sold in Canada, marketed specifically to pregnant women.

The FDA says because the drug was withdrawn by its maker and not the agency for any reasons of safety or efficacy, it may not be difficult to bring back.

There is a large body of available epidemiologic research, including both case-control and cohort studies involving thousands of births. These findings lead to the conclusion that Bendectin is not associated with increased risk of major congenital malformations, including heart disease, cleft palate, cleft lip with or without cleft palate, or limb-reduction defects.

Doctors and scientists agree that studies have shown Bendectin poses no detectable risk of birth defects. A comprehensive review of research studies from over 30 years of published data showed no association between birth defects and Bendectin.  “It was the best studied medication in pregnancy of all time—not just for nausea and vomiting, but the best studied, period,” said a professor of obstetrics and gynecology at Georgetown University.

Unfortunately once the drug was withdrawn from the market amid accusations of causing birth defects, many doctors became reluctant to give pregnant women any medications to relieve nausea and vomiting, and patients started refusing to take such drugs. Many pregnant women with unrelieved nausea and vomiting lose weight, become dehydrated and end up in the hospital for intravenous nutrition and fluids.

As a result, many caregivers feel if Diclectin is able to meet the FDA requirements, they would welcome it to make their patients more comfortable and avoid unnecessary hospitalization.

Recommendation
All the scientific data show that Bendectin/Diclectin is effective for managing nausea and vomiting and that it is safe for use in early pregnancy when the fetus is forming. Before taking any medication, pregnant women should always check with their healthcare provider.

Web site: http://www.marchofdimes.com/professionals/681_1820.asp


Hope this helps!

Andrea

[marje]

Andrea,
Thanks so much for your help.  I didn't even know the drug name and your information sets my mind at ease.
Marjean

[susieheim]

I was one of the thousands of women who took Benedictin in 1977 and 1980 for nausea and vomiting during both of my pregnancies. My oldest daughter has poly-cystic ovary disease and  has suffered with endometriosis  for approximately 15 years, She had been unsuccessful  during all of these years to get pregnant but just this week we have gottnen the news that her first invitro treatment was successful and she is due to give birth in late August 2008 or early September.  I can't help but wonder if this drug may have had something do with all of her female problems.

[AndiJ78]

I am not sure as the same ingredients in Bendectin are in Unisom and a prenatal. both of which can and are often allowed in pregnancy. There many things that can cause PCOS, including something as easily remedied as being overweight. Endometriosis remains a mystery to many as far as the root cause is concerned. I suppose one may never really know if the two are related. At any rate, congratulations on the upcoming grandchild!

[mistymeadow78]

I myself am in the same boat as many people  asking the golden question, did bendectin cause my fertility issues? My OB and fertility specialist says that I have no problem concieving but my issue is with carrying a healthy pregnancy past 6 weeks. I have had 9 pregnancies in total 1 resulting in an ectopic pg and 1 resulting in my beautiful daughter who as time goes by I realize more and more how much or a blessing she really is. But this still doesn't take away the pain and morning for the others lost. if there is anyone out there who can shed some more light and provide other information it would be greatly appreciated.

[AndiJ78]

Bendectin wasn't linked as far as I know, I have been asked by every OB is my mother took DES (Diethylstilbestrol) while pregnant as that has been clearly linked to spontaneous abortion (miscarriage), ectopic pregnancy, and pre-term delivery.

http://aje.oxfordjournals.org/cgi/content/full/154/4/316

As far as Bendectin, it has still been widely used around the world. I did come across one study that mentioned an increased risk of pyloric stenosis, but yet another that suggests the use of Bendectin is linked with a DECREASE in congenital heart defects. As you can see, the research is still be performed and can show many different end results.

But I have not found any conclusive evidence to link it with infertility.

I, too, have suffered through multiple losses, 5 total. But I cannot imagine how hard it must have been on you to lose so many.  I was blessed with three boys, my first came after my 3rd loss and then one loss between my first and second son and then another between my second and third . I underwent several tests after my 4th loss, all of which led to no conclusive answers. They were made aware of the prenatal exposure to Bendectin, which was considered insignificant. In the end, my testing pointed to "bad luck."

I suggest you google "Bendectin and Infertility" or "Prenatal exposure and infertility" The results brought back so much information, way too push to post here.

I hope some day you find your answers.

[TucsonKate]

Hi Susie:
I am also doing research on morning sickness drugs that my mom may have taken in 1980 to see if any of them are related to my fertility problems.  I am 28, and have also been diagnosed with PCOS.  We have been trying to get pregnant for 3 years.  I have had two miscarriages and no successful pregnancies.  If you find out any more link between Benedectin and PCOS/infertility please post your info!  I would be very interested to know.  And congrats on the grandbaby, I'm thinking positive thoughts for you.

[NicoleBurns]

Hi, just wanted to let you all know, I came across this page while researching general materials involving Bendectin to supplement a legal paper I am writing. I am very familiar with the case itself and am writing about the particular scientific grounds that were at issue in that case, as it is a landmark for use of expert testimony. The case itself makes it very clear: the drug manufacturer had a vast epidemiological study using about 130,000 people, and found no link to the defects, BUT the people who were suing alleging defects caused by the drug had several other experts, all very well renowned, who reanalyzed the SAME information and found a link, as well as doing many other kinds of tests (animal, test tube, etc) and were all of the opinion that the drug DOES cause birth defects. Please just be aware that informal research on any drug you think you might take is not enough, you will come up with lots of contradictory information on old drugs, and very positive information on new drugs: the FDA and others have literally dropped the ball on this, if you can possibly avoid taking drugs at all during pregnancy that is your best bet by far. Keep in mind that the drugs being put out over the last 10 years or so are only tested by the companies that make them, and all negative research is NOT PUBLISHED, so even doctors will not have access to it. Hope that is helpful, and good luck.

[Damron]

I am 31 yrs old, and male. Both my mother and her sister were taking "BENEDECTIN" in 1977.  I and my cousin was diagnosed with enlarged aortic valves with abnormalities, sadly he did not survive a 2nd birthday. As I survived a grocery list of defects began showing. My feet are flat, all 10 toes have fused knuckles (they dont bend), my fingers are increasingly curling down and toward the thumb. I've struggled with fainting, cesures, migrians, and bowel disorders since birth. In my mid-20's diagnosed with mitral and tricuspid valve stenosis. At 28 I recieved a prostectic mitral valve and told to expect surgical attention of the tricuspid within 5-10 yrs.

65 % of females and 40 % of males born 1976-1982 with in utero exposure to "BENEDECTIN" have some type of physical abnormality. This seems to be more than just "bad luck" to me. This drug was shelved when cost exceded profit for that reason alone. 25 yrs later "BENEDECTIN" (minus the vitamin B-6) is "safe again", being sold again, and guess why ..... it's profitible again. I wonder what this comment board will look like in 2010, does history really repeat itself?

[tootsie850]

My mother took Bendectin when she was pregnant with me in 1976.  I have two older sisters and one younger sister.  Mine was the only of my mother's pregnancies in which Bendectin was taken.  None of my sisters has had any difficulting in becoming pregnant nor carrying their babies to full term.  I, on the other hand, have had countlesss problems with infertility and miscarriages.  Coincidence?  Maybe, but I have been extensively tested for the cause of my infertility and no apparent cause has been found.  I am not overweight, nor do I have any physical abnormalities.  Should I just chalk my situation up to bad luck or coincidence?  Possibly.
If you are looking for the FDA to come out and say, "Ooops, sorry.  Yeah, it really does cause birth defects." It's just not gonna happen.  If you're one of the moms who took Bendectin back in the 70's and you're blaming yourself for your daughter's infertility, DON'T.  You did nothing to purposefully hurt your child.   However, if you are a mother who is considering taking any medication during pregnancy, please do your own research.  The FDA and health care professionals are not going to tell you if any drug is 100% safe because they simply do not know.  There is no way for the FDA to say that a  drug is not harmful until the public tries it for a few years.  That's when they come out and say, "Oops we didn't know it could do that.  Stop taking it."  Don't be an "oops".  Be dilligent in your research and don't get all of your information from any one individual or source.  Hope this is helpful.  Best of luck to you!