When women get pregnant, it seems like everyone has a story about what to expect regarding morning sickness. Family, friends, and strangers always have sympathy and home care advice, commiserating over how morning sickness is just a fact of pregnancy and nothing to worry about. But what if an expectant woman starts to lose weight, vomit blood, and experience fainting spells? If she decides to go to the hospital or seek out the care of a physician, she may learn that it’s no normal morning sickness—it is the much more serious and painful hyperemesis gravidarum.
Studies estimate that the vast majority, or between 70 and 80 percent, of pregnant women experience morning sickness, but some will suffer the more severe hyperemesis gravidarum (HG), which can be so severe that it prompts hospitalization. Most recently, Duchess of Cambridge Kate Middleton experienced HG during her two royal pregnancies before giving birth to son Prince George and daughter Princess Charlotte.1 For pharmacists treating expecting mothers with this severe form of morning sickness, the anti-seizure drug gabapentin may help to provide some welcome relief.
How Does Compound Gabapentin Ease Hyperemesis Gravidarum Symptoms?
Hyperemesis gravidarum is extreme nausea and vomiting during pregnancy, leading to ketosis, or five-percent weight loss or electrolyte imbalance. While pharmacology treatments may not be required in milder cases that can be treated with nutritional adjustments and rest, more severe cases can send women to the hospital to receive intravenous rehydration fluids and anti-emetic medication for nausea relief. Severe untreated cases have even been known to terminate in spontaneous abortions. The causes are currently unknown, but studies have alternately attributed HG to hormones, gastrointestinal dysfunction, nutritional deficiencies, asthma, allergies, H. pylori infections and other issues, none of them conclusively.2
Some women diagnosed with HG are lucky enough that it responds positively to regular anti-emetic medications and IV fluids, and are able to return home after only a few days in the hospital and careful monitoring through the rest of the pregnancy. Many other women who suffer from HG do not find the same relief with easily available medications, and although they can turn to complementary treatments like acupuncture, until recently their options were limited. The first medical studies positing that the pharmaceutical compound gabapentin might be an effective anti-nausea drug for HG were published only a handful of years ago, but already health care professionals and HG support groups have helped move clinical trials of gabapentin forward.
Pharmacists will usually prescribe patients medication involving the pharmaceutical compound gabapentin for antiepileptic purposes. It is classified as an anti-seizure or anticonvulsant drug, and works by affecting nerves and chemicals in the body that cause pain and seizures.3 A 2010 pilot study in the journal Early Human Development found that gabapentin treatment reduced nausea and emesis in seven pregnant women diagnosed with HG by 80 and 94 percent. 4
A subsequent 2012 case study that cited the 2010 pilot was published in the journal Innovations in Clinical Neuroscience about a 34-year-old pregnant woman diagnosed with HG at six weeks gestation. The patient had experienced spontaneous abortions in two previous pregnancies, and her doctors placed her on a regimen of gabapentin at 300 mg. This pregnancy ended in a successful delivery, with significantly reduced symptoms of HG. 5
Following the FDA’s approval of further research into whether compound gabapentin might be an effective HG treatment, University of Buffalo School of Medicine and Biomedical Science professor Dr. Thomas Guttuso applied for a grant from the National Institutes of Health to continue the work he piloted in the 2010 study. The grant was awarded in 2014 and clinical trials commenced.
What’s Next for Gabapentin Treatments for HG
Awareness of HG has increased in the past few years, thanks in large part to exposure from celebrities like Kate Middleton being diagnosed with HG and bringing the illness to public attention. Researchers estimate that HG occurs in between one and 20 pregnancies per 1,000 and that about 59,000 women require hospitalization from HG symptoms, but experts believe that number is lower than the reality and that many cases go unreported. Many women may believe they are just experiencing particularly bad morning sickness and never know they have HG. 6
The clinical trials that began in 2014 are a promising start to getting to a medication developed from compound gabapentin specifically for women suffering HG. Medications are so often created for medical standards drawn from males, that any progress in compounding medication specifically for diseases that affect predominantly or exclusively women, such as breast cancer or HG, should be encouraged. Gabapentin has proven to be an extremely flexible API that can be compounded into a number of medications to aid patients, and formulations for HG-alleviating medications should be no different.
Dr. Guttuso estimates that the clinical trials will take between three and four years total, and with Pfizer’s patent for gabapentin under the name Neurontin set to expire on April 24, 2017, increased research could lead to more innovation in relief medication for HG sufferers. With the clinical trials reserved for women whose HG does not respond to traditional antiemetics, the research can lead to relief for more women diagnosed with HG than the medical community can treat now. 7
Compounding pharmacists and physicians who conduct in-office compounding can keep their eye on the HG research, and keep in mind that compound gabapentin can be acquired from reputable suppliers to help provide patient anti-seizure relief now.
Pharmaceutica North America is a leading provider of high-quality compounding kits and active pharmaceutical ingredients to help compounding pharmacists and health care providers give their patients the best possible care. Contact us to learn more about gabapentin and its many uses for providers and pharmacists who wish to improve patient care.
“Hyperemesis gravidarum: ‘Kate Middleton’s ongoing condition is much worse than just morning sickness’” Sept. 27, 2014, http://www.theguardian.com/uk-news/she-said/2014/sep/27/hyperemesis-gravidarum-kate-middletons-ongoing-condition-is-much-worse-than-just-morning-sickness ↩
“Hyperemesis Gravidarum: Signs, Symptoms and Treatment,” Aug. 2015, http://americanpregnancy.org/pregnancy-complications/hyperemesis-gravidarum/ ↩
“Hyperemesis gravidarum,” Nov. 16, 2014, https://www.nlm.nih.gov/medlineplus/ency/article/001499.htm ↩
“Gabapentin use in hyperemesis gravidarum: a pilot study,” Jan 2010, http://www.ncbi.nlm.nih.gov/pubmed/20015600/ ↩
“A Case of Treatment Refractory Hyperemesis Gravidarum in a Patient with Comorbid Anxiety, Treated Successfully with Adjunctive Gabapentin,” Nov-Dec 2012, http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3552461/ ↩
“NEW DRUG RESEARCH FOR Hyperemesis Gravidarum (HG) – Neurologist conducts trial research over the next 4 years,” July 17, 2014, http://www.helpher.org/blog/new-drug-research-for-hg-4-year-trial-begins-at-the-university-at-buffalo/ ↩
“Drug combating severe nausea in pregnancy begins clinical trial,” June 19, 2014, http://medicalxpress.com/news/2014-06-drug-combating-severe-nausea-pregnancy.html ↩
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