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Hyperemesis Gravidarum and Ondansetron: a critical response to media coverage

June 30, 2014 by 5 Comments

by Kari Swanson

In the interest of full disclosure: I am the survivor of two pregnancies with Hyperemesis Gravidarum during which I was given Zofran and/or ondansetron. Both of my children, currently ages 9 and 4, are developmentally normal, with no health problems attributable to my use of ondansetron.

 

Birth defects from Zofran in pregnancy

A recent headline in the Toronto Star proclaims in bold face “Birth defects blamed on unapproved morning sickness treatment.” The lengthy piece about the drug ondanestron, which is sometimes prescribed off-label to women with Hyperemesis Gravidarum (HG), is written as an exposé of drug companies and physicians gone wrong, the result of which is “vulnerable” pregnant women being prescribed a harmful drug that causes their babies to be born with extraordinary birth defects as a result. This would be horrifying if it was true, of course, but, it’s not. This article is not a scientific article. It is not a scientific literature review. It is pseudo-scientific sensationalism. One might think the goal of such an article would be to protect women and children, but like most pseudo-science involving medicine it presents very real public health risks.

According to the Hyperemesis Education & Research Foundation web site, HG is

“…a severe form of nausea and vomiting in pregnancy. It is generally described as unrelenting, excessive pregnancy-related nausea and/or vomiting that prevents adequate intake of food and fluids. If severe and/or inadequately treated, it is typically associated with:

  • loss of greater than 5% of pre-pregnancy body weight (usually over 10%)
  • dehydration and production of ketones
  • nutritional deficiencies
  • metabolic imbalances
  • difficulty with daily activities”

HG is not morning sickness. HG is just plain sickness. In my first pregnancy there were many days when I vomited in excess of once an hour. I lived with constant nausea. I vomited before getting out of bed when I woke up in the morning. I vomited in the shower. I vomited on the side of the road while driving to work. I vomited in my flower garden while weeding. I believe my record was 38 times in one day. I vomited so violently and so frequently at one point that tiny blood vessels broke in my face and eyes. It certainly wasn’t the pregnancy glow I had envisioned.

I tried all of the remedies that everyone, including my obstetricians, suggested: crackers, sips of water, lemon, ginger ale, ginger tea, ginger snaps, candied ginger, extra vitamin B, extra sleep. Nothing worked. I lost weight. At 3 months pregnant I weighed about 11% less than I did before my pregnancy. I had several visits to the ER for IV hydration. More than half way through my pregnancy, after an all-night stay in the ER for IV fluids, my OB finally prescribed Zofran. For me it was a miracle drug, because it meant that I was able to keep at least one meal down every day. It didn’t completely eliminate the symptoms, but it did make them much more manageable. When I became pregnant again 5 ½ years later and started vomiting numerous times every day at 5 weeks pregnant I asked for Zofran. I still experienced nausea and vomiting throughout my second pregnancy, but nothing like I experienced the first time. I only required IV hydration in the ER once the second time around.

HG presents serious risks to a woman’s health. Complications of HG include: dehydration, malnutrition, damage to tooth enamel, renal failure, jaundice, ruptured esophagus, and deconditioning of the heart muscle, just to name some. Some of these complications can be and have been fatal. In addition, HG can cause long term health effects. Some women experience PTSD. Others, like me, develop complications of their complications: prolonged dehydration caused me to develop kidney stones.

HG also presents risks to the child. Fetal complications of HG include: premature birth, low birth weight, neural tube defects, and congenital heart defects, among others. Also, according to the Hyperemesis Education & Research Foundation, “…prolonged stress, malnutrition and dehydration in the mother can potentially put an unborn child at risk for chronic disease (e.g. diabetes, heart disease) in later life.” And, HG can also cause fetal or neonatal death.

Clearly Hyperemesis Gravidarum is a serious health condition. It is not something that can be or should be ignored or treated lightly. Women die. Babies die. When considering treatment options, women and their healthcare providers must weigh the benefits and risks of particular treatments. The decision is not about a minor inconvenience. It is very often a matter of mitigating potential harmful or life-threatening effects.

The Toronto Star article cites data recorded in the US Food & Drug Administration (FDA) Adverse Event Reporting System (FAERS). The reporters cite this data as if it presents irrefutable proof that ondanestron is a dangerous drug that caused harmful effects to babies. But, the truth of the matter is it does no such thing. The FDA states on the FAERS site:

FAERS data do have limitations. First, there is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event. Further, FDA does not receive reports for every adverse event or medication error that occurs with a product. Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event. Therefore, FAERS data cannot be used to calculate the incidence of an adverse event or medication error in the U.S. population.

Let me reiterate: the FDA does not require that a causal relationship between a product and event be proven. This means that random, purely coincidental health conditions may be reported as side effects of a drug. FAERS data are useful for looking for trends or potential side effects that might have been caused by a drug, but they are not proof that a side effect is caused by a drug. FAERS data should be used for further study. They should not be construed as concrete evidence of a causal relationship.

The use of ondansetron in pregnancy has been studied. The Toronto Star article sites some of the research, but a news article is not a scientific literature review. The reporters do not present the totality of research on the subject, and what they do present is presented in a manner that shows bias in favor of their own assertion: that ondansetron causes birth defects. There are, however, numerous other scientific studies that indicate otherwise. Anyone can easily research the topic for herself (or himself) by utilizing the freely available medical research database PubMed.

Although it has been studied, the use ofondansetron in pregnancy is considered an off-label use. It is unfortunate that the Toronto Star article presents off-label use of medications so negatively. Off-label prescribing is common and sometimes is the best or only treatment option for certain conditions. While it is true that sometimes off-label use of a medication might later be proven (by research) to be of no therapeutic value, or worse: harmful, sometimes off-label use later becomes an FDA approved use after further research supports it. According to WebMD certain beta-blockers once only used for the treatment of high blood pressure and used off-label to treat heart failure later became approved prescription treatments for heart failure.

Despite the fact that use of ondansetron to treat HG is off-label, the prescribing information for Zofran (ondansetron from GlaxoSmithKline) states:

Pregnancy Category B. Reproduction studies have been performed in pregnant rats and rabbits at daily oral doses up to 15 and 30 mg/kg/day, respectively, and have revealed no evidence of impaired fertility or harm to the fetus due to ondansetron.

Pregnancy Category B is defined by the FDA as follows: “Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.”  The safety and categorization of drugs varies from country to country. For example, acetaminophen is US FDA Pregnancy Category C (less safe to use in pregnant women than ondansetron!), but in Australia acetaminophen is Australian Pregnancy Category A, which means Australia considers acetaminophen to be safer for pregnant women than the US FDA does.

Ondansetron is not entirely without risks or side effects.   The FDA, like Health Canada, issued warnings about potential heart risks, specifically a heart rhythm problem called QT prolongation. However, those risks very clearly apply to people with Long QT syndrome, those with underlying cardiac defects, those with low potassium or magnesium, and people taking other medications that can cause QT prolongation. They did not withdraw the drug from the market. Many thousands of people have taken ondansetron with no apparent harm to their hearts.

Furthermore, many women, including those who have not taken ondansetron or any other drug, give birth to babies with birth defects every year. According to the US Centers for Disease Control and Prevention (CDC), “Birth defects occur in about 3% of all live births.” Recent CDC data on the prevalence of birth defects in the US between the years 2004 and 2006 show an estimated prevalence of 4.71 in 10,000 babies born with atrioventricular septal defect, for example. HG is associated with an increased risk for fetal cardiac defects, but women without HG and who have not taken ondansetron also give birth to babies with heart defects. According to the National Heart, Lung and Blood Institute, “doctors often don’t know why congenital heart defects occur.” Leaping to the conclusion that the heart defect of one infant reported in FAERS was caused by ondansetron is wildly inappropriate.

I do not speak for all women who have experienced HG, but I and more than one of my “HG sisters” found the Toronto Star article disturbing. It is sensationalist journalism that has the potential to cause women or their healthcare providers to delay or avoid effective treatment at the risk of their/their patients’ own or their babies’ immediate or long-term health or even at the risk of their lives.

For another look at the safety of odansetron during pregnancy, see this Huffington Post piece breaking down a Danish study of 1,970 births where the drug was used during pregnancy.

 

kariswansonTLBKari Swanson, MLS, is a daughter, sister, wife, mother of two, member of Generation X and an admin for The Leaky B@@b Facebook page. She has been an academic librarian for 15 years. She blogs occasionally over at Thoughts from BookishMama. 

 

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I don’t know how to tell you about Hyperemesis Gravidarum

May 15, 2014 by 29 Comments
by Jessica Martin-WeberHG awareness 2014

Today is Hyperemesis Gravidarum Awareness Day and I don’t know what to say.  I don’t know how to tell you why this matters to me or what HG is like.  Though I’m used to being able to express myself fairly well in written word, for some reason I just can’t find the words.  The truth is, I just don’t know how.  There’s too much and it is still so hard to talk about.

I don’t know how to explain the way HG robs everything wonderful, everything beautiful from pregnancy.

I don’t know how to tell you that though I wanted every one of my babies, I never wanted to be pregnant.

There are no words to describe the guilt I felt and grief I sometimes still have over hating pregnancy.

I don’t know if I can even begin to explain how much I wanted to “just eat” but every time I ate my insides would turn inside out and punish me for hours until there wasn’t even bile left.

Or the courage it takes to admit I wanted to end my pregnancies or my life.

And I don’t know how to tell you that sometimes it was hard to hear about or see happily, glowing pregnant women.

Because I know, I KNOW that even with that I am one of the lucky ones.  I got to have my babies.

I don’t know how to tell you that being told I was lucky I got to be skinny while pregnant or how good I looked made me crumble that people couldn’t see how I was dying, physically and emotionally, on the inside.

I don’t know where to start on the toll HG takes on my family, my husband and my children have suffered under this burned more than I can say.

I don’t know how to explain what it’s like to vomit so much you can’t breathe.

I don’t know how to share with you how the force of vomiting and dry heaving out of control leaves you spent and dizzy and gasping for air.

I don’t know what words to use to paint the picture of never ending nausea and vomiting.

I don’t know the way to make you understand why I stopped counting how many vomiting sessions I had in a day once I reached 24 even if it was only noon.

And I really don’t know how to spell out what that looks like every day all day for 40 weeks.

Because I know, I do KNOW that it could have been so much worse.  I got to have my babies.

I don’t know if it will make sense that I couldn’t eat anything, no matter how hard I tried, not even crackers or ginger or anything else.

I don’t think you’ll want to hear how much I wanted to take said crackers, ginger, or anything else and shove them where the sun don’t shine to the next person attempting to be helpful that suggested I “just” try that.

I don’t know if I can handle sharing how my nurses would try to find a viable vein in my dehydrated body and still fail after a dozen attempts.

I don’t know how to tell you that nobody doubted me having absolutely no control over the HG as much as I did.

I don’t know if I can make it clear how much I felt like a failure every day, every time I vomited, every time I heaved.

I don’t know if blame even touches the contempt I felt for myself when my babies weren’t growing well.

Words fail me when I try to explain the confusion, depression, and physical bleakness that comes with dehydration.  I was almost always dehydrated.

And I don’t know when I’ll stop crying when I confess that I was always afraid of how this was hurting my growing baby.

Because I know, I KNOW so well that in the end it was all ok.  I get to hold my babies.

I don’t know if I can deal with your questions as to why I would continue having babies if my pregnancies were so terrible.

I don’t know why you would want to hear about how I got down to 83 pounds at 5 months pregnant, my skin yellow, my organs failing, and how as much as I wanted to just eat, I couldn’t.

I don’t know if I can keep it together to recount the things people, health care providers, said to me as I fought to get well.

I don’t know what stories to tell, like how my toddlers would pretend to throw up, that I christened every place I visited in my town, or how I would do my job in between vomiting- if I could not pass out long enough.

I don’t know if it will make any sense that I have a love/hate relationship with my PICC scar, a bittersweet reminder of what it took to survive growing my babies.

I don’t know how to describe the taste of bile and then blood on my tongue for weeks at a time.

The gratitude I feel for those that believed me, fought for me, and took risks for me defies adequate expression, I know they save me.

Because I know, trust me, oh how I KNOW that this agony ended well.  I get to hold my babies.

I don’t know the vocabulary required to detail what the caustic stomach juices did to my throat and my teeth and my spirit.

I don’t know how to tell you the fear I still hold that being on the maximum dose of Zofran and the drug cocktail that was poured directly into my veins harmed my babies.

I don’t know if I can voice the even greater fear that organ failure and ketosis was harming them more than the drugs ever could.

I don’t know how to narrate the experience of trying to decide if I should save the life of the mother of my existing children or hope to live through my body shutting down to try to keep growing their little sister.

Or the anxiety I have that my daughters will face the same fate when they begin to have children of their own.

Because I know, please know that I KNOW how blessed I am to even have my children.

But I know this too, more people need to be aware of HG, to help with research, and to help support those families impacted by HG.  I know this.  To learn more about HG please go to helpher.org.

 

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Why find out?

December 17, 2011 by

After sharing my thoughts on the sex of this baby and finding out (Blue hair, ultrasound, 5 girls, and Sugarbaby) I had a lot of questions asking if we don’t care what the sex is, why find out?

I’ve talked before and openly about my pregnancies and having to deal with Hyperemesis Gravidarum (HG) through out them.  To sum it up, HG is severe nausea and vomiting in pregnancy, beyond the normal morning sickness levels, that usually results in a more than 10% weight loss for the mother, poor nutrition, dehydration, and other complications.  It’s like food poisoning that stretches on for months, for me personally it’s looked like vomiting 20-30 times a day and getting down to as low as 83 pounds.  Thanks to aggressive preventative care, this time I’ve only lost 16 pounds and with regular daily fluids through my PICC line, I’ve not dealt with severe dehydration.  At this point (over 20 weeks) I’m doing better than I ever have in one of my pregnancies and am down to vomiting 3-4 times a day and  for the most part I am able to function.

Still, it’s not easy and I have to admit to feeling more like I’m managing an illness than like I’m having a baby.  Because right now, that’s exactly what I’m most focused on, managing an illness.  Sugarbaby moves and kicks a lot and my belly is growing but I feel far more connected to my PICC line than I do the child growing inside of me.  I’ve even considered naming it, the line that is.  I have named my puke bucket in the past, so deep was the connection there.

There are reasons to be concerned about ultrasounds and like many in the natural birth community, I have my reservations about routine ultrasounds in pregnancy.  I’d share links to articles and research on the issue but I’m avoiding them right now since I’m about to go have one.  But do a search, there are plenty out there.

So why would I do an ultrasound if I have concern about their safety in pregnancy?  Aside from the fact that it’s only one ultrasound we plan on having during the entire pregnancy unless medically indicated otherwise, I have my reasons.  In my experience I have seen that a pregnant woman’s mind can greatly influence her pregnancy and her birth.  We have not had ultrasounds with each of our babies, with two we felt there was no medical reason to do so.  But then we discovered something: I struggled more with depression and feeling connected to my baby both during and immediately following the pregnancy when we didn’t find out than when we did.  There comes a point where I need something to help me start knowing the person I’m growing and connecting with them more than I’m connected to my IVs.  Knowing the sex of the individual growing inside of me is like a surge of power between me and my baby, energizing my connection and helping me get excited about having them.  That excitement helps make managing my HG this small challenge along the journey of getting this person.  The tiny potential risk of one ultrasound that gives us that connection as well as the peace of mind that the medications I’m on aren’t causing my baby to grow a second head means lower stress levels, higher endorphins, and begins the emotional journey from “I’m sick” to “we’re having a baby!”

With each of my pregnancies I find I worry more that something is wrong with my baby.  I used to think it was that I know more but now I think it’s not that complex.  We’ve had 5 healthy babies (Smunchie does have a minor heart defect and it was difficult and scary for a few months) and I start thinking there’s no way we’re going to have a 6th healthy baby.  Each time I imagine something worse.  Silly?  Probably.  Very real to me?  Yep.  And so, to help me sleep and to lower my anxiety, silly though it may be, we get the scan.  What if we do have a baby that is going to have special needs?  Well, things will proceed as already planned and we’ll start learning about navigating the world of parenting a child with special needs.  That’s not the problem for me, it’s the not knowing and the imagining that is.  Boy, girl, perfectly healthy, or special needs, this baby is ours and we love it very much, none of that’s going to change.

One more question that I’ve been asked frequently and I know goes unasked even more frequently: why keep having babies when you’re pregnancies are so rough?  The short, easy answer is because I’m crazy.  The longer, more complicated answer is that for me personally, I didn’t want HG to have the say in our family planning.  Our family didn’t feel complete.  We considered adoption and had actually planned on adopting but that didn’t work out.  So here we are.  It has been a difficult decision but one I don’t regret.  Getting through each pregnancy is hell, I won’t lie, and I hate the stress it puts on my family.  But we weren’t done, so we’ve walked through it.  I know it’s not for everyone and I grieve with my HG sisters that want more children but can’t make the HG journey again.  I feel incredibly blessed.

Please, if you or someone you know struggles with vomiting and nausea in pregnancy, please visit helpher.org for information on HG.  While care and treatment of HG is improving, it has long been misunderstood, left undiagnosed, and poorly treated.  Check this list to see if what you’re dealing with is normal morning sickness or HG.

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