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\n Illustration: Olivier Heiligers\n <\/p>\n
Mention the anti-nausea medication Zofran in conversation, and like me, you may find that just about everyone you know has a story about it. My friend Laura says her husband keeps a stockpile for his migraines<\/a>. Liz does, too, as well as Meaghan, who also uses it for vertigo. Emma used it to curtail a bout with norovirus<\/a> this winter, and is \u201cguarding the remainder of the prescription like it\u2019s solid gold.\u201d Leah tells me, \u201cI have the teeniest dose always on hand for my 6 \u00bd year old who gets carsick\u2014we refer to it as her \u2018magic pill.\u2019\u201d Eva says she\u2019s been \u201ca Zofran girlie since 2013,\u201d popping it whenever nausea rears its queasy head. \u201c I used it for pregnancy<\/a>,\u201d she continues, \u201cbut I also used it recently when I was feeling slightly off and had dinner reservations at this amazing restaurant and didn\u2019t want to throw up.\u201d Ashley Grady, who I found deep in an Instagram comment section, says she\u2019s used the drug near-daily for fifteen years to manage the nausea that arises from Crohn\u2019s disease. \u201cIt\u2019s a godsend,\u201d she says.<\/p>\n It\u2019s not surprising that people would welcome a drug that so seemingly miraculously makes the agony of nausea disappear. Often taken as a dissolving capsule placed under the tongue (it\u2019s tough to swallow a pill when you can\u2019t keep anything down), Zofran, the brand name for ondansetron, is both quick and effective, all but eliminating nausea in as little as thirty minutes<\/a>. Approved by the FDA in 1991<\/a> for use in patients undergoing chemotherapy or surgery, it\u2019s changed the game for chemo-induced nausea, with one study\u2019s<\/a> authors calling it a \u201cnecessary medication\u201d in a cancer patient\u2019s arsenal. But as the aforementioned applications of the drug make clear, there are countless off-label uses, too. Zofran makes a stomach virus tolerable, reducing not only discomfort but also dehydration. The drug is a boon for those who are pregnant, hungover, or living with Cyclic Vomiting Syndrome. (Yes, that\u2019s a thing<\/a>.) Grady tells me that because Zofran helps her live with Crohn\u2019s, she can eschew other medications for the condition, such as \u201csteroids and biologics and immunosuppressants.\u201d She explains, \u201cas long as I\u2019m able to manage my nausea, I\u2019m saving my kidneys, I\u2019m saving my liver. I\u2019m saving myself 30 pounds of weight that being on Prednisone my whole life gave me.\u201d<\/p>\n Zofran works by binding to the gut and brain\u2019s 5-HT3 receptors<\/a> and blocking the action of serotonin to curb the trigger to vomit, and it\u2019s a go-to antiemetic for clinicians, with roughly 5.7 million<\/a> patients taking it each year. While you can get it from a variety<\/a> of<\/a> online<\/a> pharmacies<\/a>\u2014those sites where a two-minute telehealth visit gets you your Tretinoin or Semaglutide\u2014Zofran remains prescription-only, to the consternation of the chronically nauseous and just generally health-anxious. Conducting a telehealth Zoom while holding back vomit sounds like misery\u2014why should someone have to?<\/p>\n Nausea remains one of the only quotidian ailments for which there isn\u2019t a great OTC solution, and no over the counter antiemetic comes close to being as effective. So why is such a well-tolerated, non-addictive, widely proffered medication gate kept in this way?<\/p>\n It turns out that the answer depends greatly on who you ask.<\/p>\n The main argument doctors offer as to why Zofran is prescription-only is somewhat straightforward: In some people, it carries side effects and risks,<\/a> the most significant of which is that it\u00a0 could lead to the development of a rare syndrome called QT prolongation. (If people have this condition congenitally, it may be exacerbated by Zofran). Dr. Camille Th\u00e9lin, an associate professor in the University of South Florida\u2019s division of digestive diseases and nutrition, explains that in QT prolongation, \u201cthe interval between heartbeats is longer than normal, which causes the heart to beat irregularly.\u201d This type of arrhythmia is called Torsades de Pointes (TdP)<\/a>; it\u2019s a rapid and unpredictable heart rhythm with a mortality rate of between 10 and 20 percent.<\/a><\/p>\n Zofran can also interact negatively with a variety of medications<\/a>, including drugs that treat everything from Parkinson\u2019s<\/a> to yeast infections<\/a>, persistent heartburn<\/a>, Tourette\u2019s syndrome<\/a>, or psychosis<\/a>. Many of these drugs also prolong the QT interval, but others impact the body\u2019s serotonin receptors, just as Zofran does. Simultaneously taking Zofran and, say, a Selective Serotonin Reuptake Inhibitor, or SSRI (the medication class of antidepressants like Prozac and Zoloft) could result in a condition known as Serotonin Syndrome. If it\u2019s severe enough and left untreated, it can be fatal within 24 hours<\/a>.<\/p>\n How much of these interacting drugs do you have to take before Serotonin Syndrome becomes a concern? It\u2019s hard to say, says Th\u00e9lin, because \u201cwe all have a different liver makeup based on our genetics. Some people might be fast metabolizers or slow metabolizers, and that can really change the level of serotonin in the brain.\u201d<\/p>\n Combine these two concerns\u2014long QT intervals and drug interactions\u2014and the situation can get dangerous quickly, says Jill Deutsch, MD, a gastroenterologist and assistant professor of digestive diseases at The Yale School of Medicine. \u201cWhen people have nausea, it\u2019s often because of something else,\u201d she says \u2014 a respiratory infection, a migraine, whatever it might be. \u201cSo, the patient is likely taking something for that condition in addition to Zofran. When you use multiple medications with the risk of prolonging the QT, it raises the hairs on the back of my neck.\u201d Some migraine medications<\/a> and antibiotics<\/a> are known to prolong the QT interval, as well as certain OTC drugs, including Benadryl<\/a> and Pepcid<\/a>.<\/p>\n Similarly, Th\u00e9lin points out that nausea \u201cis a symptom, not a diagnosis,\u201d and says that if you remove that symptom with Zofran, you both muddy the diagnostic waters and potentially hinder a patient from seeking care.\u00a0 You may be thinking that anyone with chronic nausea would seek help even if they addressed their symptoms in the short term\u2014but research<\/a> has shown that as many as a third of people avoid seeing a doctor even when they suspect they should. It\u2019s conceivable that Zofran could help a doctor-wary sufferer retreat into denial.<\/p>\n Arrhythmia and Serotonin Syndrome and potentially dangerous disease-masking do feel like significant hurdles to making Zofran just another medication on the shelf at Walgreens. But from there things get more complicated, and more subjective.<\/p>\n I\u2019m on the other side of the debate,\u201d says Marlena Fejzo, Ph.D., a geneticist and professor at the University of Southern California\u2019s Keck School of Medicine. Fejzo\u2019s research focuses on women\u2019s health, with a particular interest in Hyperemesis Gravidarum<\/a> (HG), a condition during pregnancy that causes almost incessant nausea and vomiting, sometimes for the pregnancy\u2019s full duration. I had just told her that the gastroenterologists I\u2019d spoken with had highlighted the risks of making Zofran too accessible. She does not hold back in her disagreement. \u201cIf doctors were more willing to prescribe this drug for women to help them during pregnancy, then my answer would be different,\u201d Fejzo says. \u201cBut it\u2019s withheld in so many cases because of this fear of adverse outcomes. I think it would be great to have it available and let women make their own choice about it.\u201d<\/p>\n Fejzo herself suffered from HG<\/a>, so wracked by her symptoms that she was bedridden and had to receive nourishment first intravenously, then via feeding tube. Ultimately, she miscarried\u2014an outcome that, along with preterm birth, she tells me occurs in 1 in 3 cases of HG. Fejzo says she was dismissed by her doctor, who implied that she was exaggerating her symptoms. This attitude is not uncommon among physicians, Fejzo says. \u201cIt\u2019s rooted in historical sexism,\u201d she continues. \u201cI got a recording of an OBGYN, a woman doctor, teaching her medical students that when women are hospitalized with hyperemesis, it\u2019s usually because there\u2019s something going on at home or because they just don\u2019t want to get better. Those were her exact words. She\u2019s repeating this misogynistic nonsense to the next generation of medical students, and they believe her, and it just gets perpetuated.\u201d It\u2019s this attitude that may be what keeps Zofran out of the hands of the pregnant people who need it, Fejzo says: If a doctor doesn\u2019t believe your symptoms are real, they\u2019re unlikely to prescribe you a drug to cure them. Fejzo tells me she has seen cases in which wanted pregnancies were terminated because the HG symptoms were simply too much to bear.<\/p>\n Hoping to counteract the misconceptions about Zofran\u2019s risks in pregnancy, Fejzo conducted a study<\/a>. \u201cWe compared people who took Zofran who had HG to people who did not take Zofran and had HG, and then we had controls who did not have HG,\u201d she says. \u201cThe risk of adverse outcomes was increased in people with HG compared to the people who did not have it, but the risk was identical for people who had HG whether or not they took Zofran.\u201d In other words, it\u2019s not the drug that\u2019s dangerous to a fetus, it\u2019s the condition it treats.<\/p>\n Fejzo believes that the tendency she\u2019s observed for physicians to withhold Zofran from those with HG comes down to a paternalistic belief that women can\u2019t evaluate the drug\u2019s risks on their own and weigh them against the benefits. (This is not dissimilar to the demonstrated underprescribing<\/a> of pain medication to women, who are more likely to be given sedatives than painkillers as compared to their male counterparts.) Case in point, Fejzo says, is research that found a miniscule increase in oral clefts of the fetus among pregnant subjects who took Zofran. \u201cThe increased risk is tiny. Eleven out of 10,000 people who did not take Zofran during pregnancy got an oral cleft in their fetus versus 14 out of 10,000 among those who did take it. So, there were only three more out of 10,000, which is a way lower risk than, for example, the risk of miscarrying after an amniocentesis, which is one in 200 to one in 400. Yet doctors allow women to make that choice all the time.\u201d<\/p>\n I also spoke with Dr. Nicholas Ghionni, a Baltimore-based pulmonologist who works in the ICU. He had commented on an Instagram post<\/a> regarding the dangers of Zofran by Dr. Zachary Rubin, the doctor behind @rubin_allergy, an account with 1 million followers. The post explored the QT interval and Torsades de Pointes concerns, with countless people ringing alarm bells in the comments. \u201cI take this medicine every single morning,\u201d one person wrote. \u201cNow I\u2019m freaked out.\u201d Another said, \u201cI had no idea. I thought it was safe.\u201d But Ghionni\u2019s retort called for a dose of perspective. \u201cTorsades was seen in patients who took massive doses in a chemo study (32 mg at a time),\u201d he wrote; the standard dosage for run-of-the-mill nausea in adults is far lower, around 4 milligrams. \u201cFurthermore,\u201d Ghionni continued, \u201chow does this matter if you go to your PCP and get Zofran and then go home? You\u2019re not on continuous monitoring.\u201d In fact, in his daily work in the ICU, Ghionni tells me, he doesn\u2019t bother with heart monitors for a low dose of Zofran.<\/p>\n \u201cMedicine is very dogmatic,\u201d Ghionni says. \u201cAnd all of these rules are hammered into you as an intern\u2014one of which is \u2018Zofran causes QT prolongation, be careful.\u2019\u201d To Ghionni, this is just an echo of how medicine has always operated: Everyone practices in the way they\u2019ve been taught to, until \u201cpeople come along and challenge the dogma and ask, okay, do we have evidence of harm or benefit?\u201d Zofranophobe doctors might start by reading the actual FDA warning<\/a> attached to the drug, because Ghionni\u2019s comment was correct about the discrepancy between the standard dose of 4 milligrams of ingested Zofran and the 32 milligram intravenous dose that was was associated with prolonged QT. Per that warning, the 32 milligram dose should be \u201cavoided,\u201d but there\u2019s no risk mentioned regarding the far lower doses of Zofran that most people receive. So why, Ghionni wonders, should Zofran be, \u201cpicked out as the bad boy on the block?\u201d<\/p>\n Which brings us to a glaring logical flaw in the prescription-only side of the Zofran debate: Ondansetron is arguably no more dangerous or prone to side effects than any number of OTC medications. Take\u00a0 acetaminophen (aka Tylenol) for example, too much of which can cause a rare fatal skin reaction and liver failure<\/a>, or cough syrups with Dextromethorphan<\/a>, which is hallucinogenic in high doses and famously prone to abuse. \u201cI totally get why people say, yes, Zofran should be available, and others say, no, it shouldn\u2019t be available,\u201d says Deutsch. \u201cI tend to argue that things like Advil and Tylenol shouldn\u2019t be so readily available over the counter, even though they\u2019re likely safe in most cases.\u201d She thinks it all comes down to timing, and the way the FDA has changed its approach to regulation over the years: \u201cIt\u2019s very, very, very infrequent that you see a new medication regulated by the FDA available over the counter anymore. If Zofran had been around 20 or 30 years earlier, it probably would\u2019ve been OTC.\u201d<\/p>\n Deutsch also taught me an industry term: therapeutic misadventure. It refers to adverse effects\u00a0 stemming from the attempt to address a medical problem\u2014and, in this context, to the ways in which the average person consumes medications they don\u2019t realize are dangerous. \u201cYou\u2019re trying to treat your pain or nausea,\u201d Deutsch says, offering a hypothetical. \u201cYou take one pill, and it helps a little but you\u2019re still in discomfort, so you think, wouldn\u2019t a second pill help more? It makes perfect sense, except that with medications, more is not necessarily better.\u201d It\u2019s easier to make OTC medication mistakes than you may realize, and every year, roughly 178,000 people<\/a> wind up in the hospital for this reason. A Zofran misadventure doesn\u2019t seem outside the realm of possibility; if you\u2019re nauseous, you\u2019re distracted. Did you take the last dose two hours ago, or three? You took it in tablet form, then threw up\u2014do you take it again? You skipped a dose because you felt okay, but now you\u2019re queasy. If the directive on the package is to take no more than 24 mg per day, and you\u2019d still be below that threshold, can you take two? The point is, it\u2019s easy to get lost in the nuances, and hidden in all that medicine minutiae are opportunities for mistakes.<\/p>\n But is it likely that one of those mistakes will be to accidentally take 32 milligrams of Zofran intravenously? No, probably not.<\/p>\n So, should Zofran be stocked near the Pepto Bismol, freely bought and used by all who need it? Is it kept from patients because of sexism, or inflated fears, or dogmatic thinking, or because it was created thirty years too late? It\u2019s hard to say. But the case for OTC ondansetron is compelling. Prolonged QT intervals are rare, as is Serotonin Syndrome. The FDA could require, as it does for cold medicines containing pseudoephedrine<\/a> (a key ingredient in methamphetamine), that Zofran only be sold in limited doses to those able to present a government ID. And anyway, as Fejzo points out, even in hospital settings there\u2019s often not as much attention paid to arrhythmia-related concerns as you might think. \u201cEven when Zofran is prescribed,\u201d Fejzo says, echoing Ghionni, \u201care people on it being monitored? Are they checking their hearts? No, I doubt it.\u201d A Reddit post<\/a> from late last year in r\/nursing suggests not: \u201cWhen I worked med\/surg, we gave [Zofran] to almost everyone who needed antiemetics and we didn\u2019t need the patients on tele or EKG to do so\u201d\u2014meaning nurses were not asked to monitor patients\u2019 heart rhythms.<\/p>\n During our conversation, Fejzo had asked, \u201cWhat were the doctors you spoke to worried about, the QT interval? Constipation?\u201d<\/p>\n \u201cThe QT interval and drug interactions, mostly,\u201d I said.<\/p>\n \u201cYeah, well,\u201d Fejzo answered, \u201cyou can put that on the bottle.\u201d<\/p>\n Note: This article is for informational purposes only and is not intended to serve as medical advice, consult your doctor before undergoing medical treatment.<\/p>\n Stay in touch.<\/p>\n Get the Cut newsletter delivered daily<\/p>\n Vox Media, LLC Terms and Privacy Notice<\/p>\n