Drug for Morning Sickness Previously Linked to Birth Defects is now FDA approved - Mothering Forums
Natural Parenting News > Drug for Morning Sickness Previously Linked to Birth Defects is now FDA approved
HWBMama's Avatar HWBMama 08:07 PM 04-11-2013

About 30 years ago, a drug to ease morning sickness called Diclegis was pulled from the market after thousands of law suits were filed from mothers who believed the medicine caused birth defects in their babies.  The makers of Diclegis are now saying that the accusations back then were unfounded and the medicine has recently been given the highest possible rating from the FDA (Category A).

 

 

From ABC news:http://abcnews.go.com/Health/fda-approves-morning-sickness-pill-pulled-market/story?id=18914496#.UWdrPrU4vXM

Quote:

Dr. Keith Eddelman, the director of obstetrics at the Mount Sinai Medical Center in New York City, agreed. He said the drug should never have been taken off the market in the first place.

"It is not a controversial drug, and the data is very convincing. ... This new FDA medication is a great option for pregnant women suffering from morning sickness," he said.

 

 

As a mother who endured severe morning sickness I can say that this does in fact sound tempting and wonderful.  However I tend to agree with Dr. Jennifer Ashton, OB-GYN, who was quoted in the article:

 

 

Quote:

Ashton also recommended trying lifestyle changes, such as eating small, frequent bland snacks, acupressure wrist bands and meditation before taking medication to ease morning sickness. But if symptoms become overwhelming, Ashton said Diclegis could be a good option.

"Vomiting a few times a day may be something a pregnant woman can handle for a short period of time," she said. "Vomiting hourly is not."

 

How bad was your morning sickness?  Would you have resorted to Diclegis?



HayesMom's Avatar HayesMom 02:13 PM 04-12-2013

With all 3 of my pregnancies I had severe debilitating nausea.  I was throwing up every 15 minutes to the point of hospitalization!  With my third my midwife gave me a drug called Zophran.  Not sure on the spelling.  My son was born with a heart defect and now we have to go to the cardiologist every 6 months and we are always watching him very closely.  I wish I had just dealt with being sick but at the time my doctors thought the outcome was worth the risks.


michelleepotter's Avatar michelleepotter 02:31 PM 04-12-2013
Quote:
Originally Posted by HayesMom View Post

With all 3 of my pregnancies I had severe debilitating nausea.  I was throwing up every 15 minutes to the point of hospitalization!  With my third my midwife gave me a drug called Zophran.  Not sure on the spelling.  My son was born with a heart defect and now we have to go to the cardiologist every 6 months and we are always watching him very closely.  I wish I had just dealt with being sick but at the time my doctors thought the outcome was worth the risks.

I'm so sorry this happened to your son, but please don't beat yourself up. Severe hyperemesis like that can kill you and your baby; it's not something you can "just deal with." You took a relatively safe drug (Class B) that hasn't actually been shown to cause the birth defect afflicting your son. It's possible the two have nothing to do with each other.
Lazurii's Avatar Lazurii 02:55 PM 04-12-2013

I am so sorry, HayesMom, that you son has heart problems.  hug2.gif

 

Zofran is considered pretty safe, though.  We have to give it to my son when he starts vomiting because he just.  won't.  stop.  We've tried everything and the longest he went was 10 and he still didn't stop on his own.  So I consider Zofran one of those useful drugs that can be overused.  I had a friend on a Zofran pump for extreme hyperemeisis for all of her pregnancies and her children are very healthy.


deailedlace's Avatar deailedlace 06:35 PM 05-05-2013
Hi all
I did indeed have debilitating pregnancy sickness from month three until the day I gave birth..actually threw up with every contraction as well. I took diclectin for two weeks after spending some time in and out of the womens hospital on iv from hydration. I used this in combination with low dose of gravol. I was throwing up nonstop everyday and my appetite was terrible. Could only eat baked potatoes, plain crackers, soup broth, gingerale and boost for a long time. I did not find the meds helpedand they made me really drowsey so I didnt take beyond those two weeks. I just had to suffer through it...lost my job in the process for too many sick days :S i tried pretty much everything, somedays somhings worked better than others but I certainly didnt find a cure. Despite my worries, I gave birth to a healthy and thriving 7.9 lbs dd! Worth every lost meal wink1.gif needless to say I will never drink boost or gingerale again...cant even smell the stuff lol
pek64's Avatar pek64 07:10 PM 05-05-2013
I had a trip to Disney planned, and got pregnant a month before the trip. We went anyway, and I had a horrible time! For five years after my son was born I could not see a Disney commercial without feeling severely ill.

I learned to keep my blood sugar up, and stretched my abdominal muscles to allow for expansion out, instead of the baby being pushed into my organs. That helped. I avoid medication, and was fortunate that I never had to be hospitalized. I don't know what choice I would have made if it had reached that point.
mt_gooseberry's Avatar mt_gooseberry 07:41 PM 05-05-2013

When I was pregnant for the first time, I got HG so bad that I bottomed out at 84lbs and spent a week in the hospital.  I would throw up over 20 times a day.  I.  Tried.  Everything!  Every remedy you have ever heard of and then some.  I finally allowed them to prescribe me medication.  Phenergan, which made me sleepy and didn't work the best, and Zofran, which is the only thing that cut down the vomiting to 2 or 3 times a day.  I would have died without it.  No exaggeration. 

 

One of the things the doctor recommended to me was Unisom taken with vitamin B6.  He said it was an anti-morning sickness medication that was banned in the US but that was still used in Canada, and that used to be suspected of causing birth defects but had been cleared of those suspicions and the FDA was delaying its reapproval for political reasons.  I tried this a few times but I didn't have the same success with it as I did with Zofran.  I bet this is the one the original post is talking about.

 

For my second pg, I began taking Zofran at the first sign of morning sickness.  I still got sick, but it was a cakewalk compared to the first time.  I was able to stop using the Zofran around 3mo, compared to 6mo the first time, and as long as I kept on top of the dosing schedule, I could function.

 

HayesMom, has it been confirmed that the Zofran is the cause of your son's heart defect?  Could it have been a coincidence?  It makes me so sad for you, your feeling like you could have prevented his condition if you hadn't taken the Zofran.  Perhaps it was nothing you did, but rather "just one of those things." 


JollyGG's Avatar JollyGG 08:51 PM 05-05-2013

I'm glad they've brought it back. Many many women create the same thing by taking Unisom and B6 and that has proven safe as well. I'm one who did. In both my pregnancies I needed it in order to keep from loosing weight. It kept the nausea at bay. It didn't go away but it got good enough that I was able to eat enough to not loose weight. I didn't feel well enough to actually gain weight either, but it helped.

 

It actually worked better for me than zofran. My problem was the nausea itself, not the vomiting. I couldn't make myself eat enough to maintain my weight with the constant nausea. Though I rarely vomited (perhaps once a week). Zofran prevents vomiting, but had no effect on my nausea.

 

Yeah, the Unisom/B6 combo made me sleepy. But, you build up a bit of a tolerance to the sleep effects and do the best you can.


rachelsmama's Avatar rachelsmama 05:57 AM 05-06-2013

I predict that sales of Diclectin will drop up here in Canada now that American mothers can get their meds locally.  I've used it, and was glad to have an option that had been around so long and was unlikely to have undiscovered side-effects.


delightedbutterfly's Avatar delightedbutterfly 05:15 PM 07-09-2013

I took Diclectin with my second and it was awesome. It's considered safer than Tylenol here in Canada. I would take it again in a heartbeat. 

Yes it makes you  bit drowsy but you are supposed to start it at a time that your body can get used to the side effects before resuming your normal schedule... Like a long weekend or similar :)


fruitfulmomma's Avatar fruitfulmomma 05:33 PM 07-09-2013

I don't know... I've never been diagnosed with hypermesis but I do have pretty severe morning sickness and acid reflux which has very often resulted in continuous painful vomiting. I have done different things which help somewhat, including a gluten-free diet (I didn't do it specifically for that but started between my 5th and 6th and it was the only thing I can think of that I changed and had drastically less 1st and 2nd trimester ms), ginger pills, prenatals high in b vitamins, eating enough protein, herbal remedies, etc... I took one single zofran this last time and woke up the next morning with the worst migraine I have ever had in my life. (Yeah, the nurse tells my hubby that headaches are a side effect as it is going down my throat.thumb.gif) Anyway, I have taken class c drugs during pregnancy before I believed the risks of not taking them at the time were worse.


erigeron 05:39 PM 07-09-2013

Both of the component drugs (doxylamine, an antihistamine, and pyridoxine, a B vitamin) are category A to start with so having the combo drug also be category A isn't too surprising. 

 

I don't get morning sickness--I just feel icky all the time--but I would take medication for it if I had to. 


Katie8681's Avatar Katie8681 07:28 PM 07-09-2013
I don't know yet how expensive Diclegis is compared to just buying doxylamine and B6. I'm betting more smile.gif
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