WhiteCoat

FDA: Zofran May Be DEADLY

Get ready for a “black box” warning on Zofran.

The FDA has just issued a “safety alert” stating that Zofran may now be potentially deadly.

The FDA is now recommending ECG monitoring in patients who receive Zofran who have potential “electrolyte abnormalities (e.g., hypokalemia or hypomagnesemia), congestive heart failure, bradyarrhythmias, or in patients taking other medications that can lead to QT prolongation.”

After all, Zofran has now gone generic like previous anti-nausea medications that have also received black box warnings. The FDA approved Zofran for use in 1991, meaning that Zofran has been on the market for twenty years.

Now, through diligent research, the FDA has decided that that Zofran may cause QT prolongation — just like most of the other anti-nausea medications. As a result, GlaxoSmithKline has been ordered to perform studies to determine whether Zofran could prolong QT intervals, and, if so, to what extent.

Since the FDA states that it has been performing “ongoing safety studies” … for the past twenty years … why doesn’t the FDA actually publish the results of those safety studies that led to the posting of its alarming “safety notice”?

Now we have one less medication in our armamentarium to treat nausea and vomiting.  I suppose we can always give ginger root until that gets a black box warning, too. It’s only been around for a few centuries.

Whoa. I think that my heart just skipped a beat. Reading FDA safety notices may have caused me to have QT prolongation. I think that we need to put black box warnings on FDA safety notices and no one should read them without proper EKG monitoring.

Who do we get to study that?

56 Responses to “FDA: Zofran May Be DEADLY”

  1. SeaSpray says:

    Post operative vomiting is one of the worst experiences ever and can last for hours.

    Ginger root – you’re funny. :)

  2. Annette says:

    This is really scary to me. I was pregnant with twins and took Zofran off and on due to hyperemesis (and, by the way, your offhand remark about “just taking ginger” is spoken like someone who has never experienced extreme all-day sickness and a twin pregnancy). I delivered the babies while in heart failure and was diagnosed with peripartum cardiomyopathy and I can’t help but wonder now if the two are somehow connected.

    • storkdoc says:

      Well peripartum cardiomyopathy was described long before Zofran ever came around. Zofran may cause an abnormal and potentially fatal heart rhythm. That’s different from peripartum cardiomyopathy.

    • ERdocJaded says:

      QT prolongation is completely different problem than CM

    • creative mommy says:

      I too had the extreme nausea early in my pregnancy, I couldn’t hold down the Zofran u swallow or the chewable. In fall of 2009 I was put on a Zofran pump, to give me a constant dosage, it kept me out of the hospital. I never had any issues from Zofran, it helped me be able to hold food and liquids down. I also have a stomach ulcer, normally if I get a bad stomach bug I have to be given Zofran as they have tried several generics on me in many years of my life & since they wouldn’t work, now they just go straight to giving me Zofran. I’ve had a stomach ulcer maybe since 2nd grade but they couldn’t do the precedure (putting camera tube down my throat) but in 7th grade they finally did and found it. I also have a sensitive heart to certain things, especially caffeine. Zofran didn’t give me problems. Oh and before I was prego I believe it was, I was given several samples of little boxes of Zofran chewables. Why, acid reflux. It worked good, so I guess my body just doesn’t have any issues with Zofran.
      Gotta give u props for making it threw with having twins, just one baby alone inside us is hard enough, especially one who gets to 21 1/2inches, he had strong kicks, lol.

  3. girlvet says:

    You have got to be kidding…zofran is the gold standard these days. What are we supposed to use now? Ativan? That might not be such a bad idea…patients less anxious too and easier to deal with.

    • maxtek73 says:

      i have been suffering chronic nausea and vomiting for several years now, when i moved to san francisco my new doctor did not like phenergan and changed me to ondansetron or zofran, after only 2 doses i woke up seeing blacked out peripheral vision like looking through two tires, and i stopped them right away because when ever anything happens i don’t expect i research it, i found it has a extreme side effect warning about mixing this with methadone, im surprised my doctor didn’t know about the reaction, anyhow i still suffer vision problems now and they haven’t gone away.

  4. Steve says:

    Hmmm…wanna bet that GlaxoSmithKline has a new anti nausea med about to hit the market…Droperidol part 2?

    Give me a break- its safer than tylenol

  5. WarmSocks says:

    Hmmm… Maybe at 7:15 when the nurse comes to put my next dose of zofran in my IV, I’ll decide that I’m not feeling so nauseated as to need the stuff.

  6. hannah says:

    Whoa. Zofran’s been around for 20 years? I remember getting it about a dozen years ago and it was touted as this very expensive, new wonder drug.

  7. ExpatDoc says:

    We still have droperidol down under in New Zealand/Australia – never got rid of it when it “black boxed” in the USA. Works better than Zofran in many cases, especially cannabis hyperemesis.

    The big question is what options will remain for vomiting kids if Zofran wafers are removed from use.

  8. Anonymous says:

    I didn’t know they made a drug that would stop vomiting. Cool…as long as it doesn’t kill you haha.

  9. ERdocJaded says:

    What about all those chemo patients who take massive doses of Zofran? Anyone aware of any large number of case reports of any of them dying of SCD?

    • rapnzl rn says:

      This chemo nurse says (anecdotally) zofran – even at the huge doses given for cancer patients, is, without a doubt, the safest thing out there. (Ask me again after I spend an entire 12 hours chasing patients temporarily altered on ativan, droperidol, or compazine!)
      This is blatantly about something other than patient safety.

  10. EP Doc says:

    Doesn’t matter that there’s a black box warning. There will be commercials from those hungry lawyers ‘Ever take Zofran? Have palpitations? Call 1-800-we care about you! Life in America.

  11. doc99 says:

    Follow the money!

  12. DefendUSA says:

    Yeah, twenty years…it does make you want to scratch your head. I have a former Army comrade who was working for a Pharma company. This guy is freaking brilliant. He worked on many drug research projects.

    His research and findings put him on the opposite side of the FDA and the pharma company in terms of the approval and when he tried to express concerns based on that, they treated him like a criminal and fired him.

    It’s all about the money…Zofran is great stuff. The warnings now are simply to justify all the money they pocket and then waste, period. Some drugs take years to get to market and you don’t think they knew the risks? Oy. Money. That’s it.

  13. joebob says:

    Have you or a loved one been given Zofran? You may be entitled to CASH….

  14. I have never once seen anyone get an arrhythmia from Zofran – and I have given it to thousands of people with electrolyte abnormailities who are puking their guts out.

  15. Ash says:

    Only drugs off patent cause QT prolongation.

  16. Medical marijuana works well for nausea.

  17. zofran -> long QT -> torsades -> dead

    N/V -> aspiration/airway obstruction -> dead

    OMG we’re all going to die!

  18. ERdocJaded says:

    LOL to only drugs off patent cause QT prolongation

  19. chris says:

    Was more saddened than scard…was on simple phenegren then reglan now zofran due to black box…i have crohns and cancer and it keeps me functionable…will not freak out but get heart checks and continue…why freak out if you get checked out? Stressing will cause more heart issues i would say….feel well friends….

  20. Meredith says:

    Totally not cool to docs, but my mom gave me her 4 mg tabs she was prescribed for nausea associated with anxiety causing high BP and tachycardia. I was feeling extremely nauseated due to an increase (50 up to 100 mg) Lamictal. Took one Zoltran, still nauseated 30 min later. Took 2 more within another hour. Ended up blacking out eating a salad. Don’t remember it AT ALL. Not drinking alcohol or taking any type of sedative. Scary, but glad it was just salad eating I don’t remember. Any thoughts (other than admonitions against taking someone else’s meds)?

  21. Ann says:

    Puking my guts up vs black box warning…please, give me the Zofran!

  22. Jeannie T says:

    My daughter is a type 1 Diabetic, age 16. She has been diabetic since the age of 3 and just diagnosed with Gastroparesis. The Zofran is the only thing that really helps her. I believe that we are told not to give it to the kids everyday cause insurance won’t pay for it after a while. That’s my take on all of this.

  23. Mother Hubbard says:

    Zofran, is now widely prescribed for chemotherapy side effects, severe naseau and vomiting, post-operative, and for the last 13+ years been touted as the new wonder drug for severe hyperemesis (naseau and vomiting) and prescribed during pregnancy via oral tablets ranging from 4-8 mg per dose 2 to 3 times a day.
    Twelve years ago, after being prescribed Zofran for hyperemesis throughout my pregnancy; my daughter was born with “multiple anomalies/abnormalities”. She has since had 10 operations in 12 years of life for hearing loss, ingueno hernia’s, diagphragmatic eventration, webbed toes, hearing tubes, just to mention a few!My daughter initially suffered from a heart murmur, and arterial stenosis for the first five years of her life as well.
    Unfortunately many people are not yet aware of the side effects during pregnancy which are involved. Many patients do not know what to make of their suspicions about “adverse drug reactions”,or even whom to report them to.
    For chemotherapy and leukemia patients (who are generally not pregnant,and some patients who suffer naseau after surgery(post-op patients can and do benefit from long or short term use of the drug for naseau (when necessary) still Zofran should not be prescribed during pregnancy and should medically, legaly, and morally be prescribed to those not carrying fetuses.
    The FDA had investigated GSK for the last several years, for various mediations, hidden negative study related information by the company about various drugs (Avandia),defrauding Medicaid, production of faulty/imitation medications such as Paxil. GSK manufactures Avandia(a Diabetic drug; which was proved to induce heart attacks), Paxil (known to cause birth effects in children of women taking while pregnant), Myodil and Fibrodil medications that GSK has already paid out $ to settle out of court somewhere around $16,000 per patient), Wellbutrin (recently in the news for being pedaled to minors; despite homicidal and suicidal side-effects),Chantix (the stop smoking medication), the Swine Flu vaccine (which was recalled in several states), then lastly you have Zofran the big topic of this blog. While many of you may be skeptical of the recent black-box warning; added to Zofran label, consider this is if GSK was willing to hide negative study findings to the very same entity which govern them, why wouldn’t they hide information from you as well? I’d say swallow at your own risk/benefit but at least know the truth about the “wonder-drug” that works “so well and effectively”…
    @EPDoc, If only it were!: “1-800- we are about you!” because “Life in America” has been extremely hard for my family and I since giving birth to my daughter”! and @joebob “have you or a loved one been given Zofran?” YES!Just because some may not have the same experience,others are not afforded the same pleasure, I personally know of three victims in my state alone, and the four other women which have contacted me from as far as Australia who have children born with the same “abnormalities” already reported to the FDA; after being prescribed Zofran during pregancy.

    • miguel says:

      No way all those abnormalities were caused. By zofran, it never has never will, check ur gene pool or just unfortunate mutation

      • Momma of 3 says:

        Was my thoughts exactly. There has to be some other explanation for all of the abnormalities in her poor little one. Highly unlikely that the Zofran caused all of those. That or my lil’ one I’m carrying now is going to have issues because Zofran is all that helped even a little bit for a couple of weeks.

    • Mother Hubbard says:

      http://www.facebook.com/MA‘Z(Mother’sAgainstZofranBirthDefects)

  24. Mother Hubbard says:

    @EPDoc, If only it were!: “1-800- we are about you!” because “Life in America” has been extremey hard for my family and I since giving brth to my daughter”! and @joebob “have you or a loved one been given Zofran?” YES!Just because some may not have the same experience,others are not afforded the same pleasure, I personally know of three victims in my state alone, and the four other women which have contacted me from as far as Australia who have children born with the same “abnormalities” already reported to the FDA; after being prescribed Zofran durig pregancy.

    • Momma of 3 says:

      Any evidence that this is Zofran induced effects? Everyone always wants to point blame as something. unfortunately sometimes it’s genetics’.

  25. Jane Fuller says:

    There is nothing fun about being nauseated around the clock. Even less fun vomiting. This medicine has been a miracle for me.I’d rather feel halfway decent then worry about possible side effects. So far I’ve experienced nothing but feeling better on this. I will risk it!

  26. Susan Bennett says:

    I have taken Zofran on occasion for nausea associated with IBS. I developed that a few years ago, along w/fibromyalgia. I took a drug several years ago that worked great, until they took it off the market…Can’t think of the name of it. It seems like it was around forever…then just gone. When you have a bad day w/IBS, the vomiting just goes on and on, w/me ending up in the ER, so what can I take? When you are that sick, you really lose your mind and don’t care what they give you…Between the severe pain in my stomach, the vomiting, back pain, I don’t care what they do to help me get rid of it…I usually have it quite a while before I finally give in and decide I can’t beat it on my own, then finally go to the ER. I’ve been hospitalized twice w/this for several days, where it just goes on and on…I would love to know about any new medications I could try next time… Thanks, Susan

  27. Liz Bennett says:

    That’s comforting. Laying in a hospital bed with an IV that they just put Zofran into.

  28. angel says:

    I’m sorry to hear that this drug has possibly caused birth defects however I have a friend who’s baby was born mostly blind and with a muscle disorder and she was told it was because she was a young mother, she was 19. If you look at most things they have worst possible side affects then what they are treating. Possible being the key word. I took zofran when pregnant with both my girls. I had around the clock vomiting with one of my triggers being the smell of water. Yes, water has a smell. Both my girls are healthy and my oldest starts kindergarten. Now I’m pregnant again and yes I will take zofran again.

    • beesee says:

      The baby had birth defects because she was 19 when she gave birth? Did the Dr. quack after saying this?

    • takin says:

      I was pregnant with my first child in 1985 deathly sick the whole pregnancy,they never offered anything then with my second child in 1993 still sick the whole entire pragnancy nothing offered so i suffered and toughed it out. Now at age 44 with alot of stomach issues in the past 2 months they have prescribed me the zofran and it actually works. I am having my gallbladder removed next week and pray that it fixes the issue? If it doesnt it will be likely that I have terrible nerves and that may be my problem and I just hope they continue to give me the zofran. Although if you can stand it while pregnant dont take it just tough it out its not easy just remember that sweet baby on the way. You can do it.

  29. Hazel says:

    I am only talking about giving Zofran to small children to stop dehydration.

    My son was given Zofran at the emergency room at the age of two to keep him from becoming dehydratated. He was complaining of a tummy ache and had been vomiting for 24 hours. Giving Zofran to stop dehydration in small children is (I was told) a common practice.

    As it turned out his tummy ache was food poisoning (e.coli OH:157 strain) and the Zofran kept his body from doing what it naturally needed to do ~ vomit to expell the bacteria. After not vomiting for about 18 hours it started back up with a vengance and he developed colitis (bloody diarrhea) and was in total kidney failure within 36 hours from taking Zofran. His E.coli had turned into HUS (Hemolytic Uremic Syndrome).

    My 2 year old, stayed at the hospital for over 1 month. Needing blood transfusions, dialysis, tubs in his lungs… Every organ in his body was being effected by this deadly bacteria ~ even his brain to the point were he was having full blown seizures. He will forever be a kidney patient…

    I will always wonder if Zofran made things worse for him. Had he been able to vomit in the begining MAYBE, just maybe his fight with e.coli would not have turned deadly. http://www.stopfoodborneillness.org/content/daltons-story

    I strongly disagree with medical doctors giving Zofran to small children, in an effort to stop dehydration. Especially, when they do NOT know the cause of the vomiting.

    Has anyone ever done a study to see if there is a coorelation between children who get e.coli and are given Zofran and the development of HUS?

    • Momma of 3 says:

      Sounds to me like the misdiagnosis was the initial cause and them prescribing the Zofran did likely exasperate his condition. I’m sorry.

  30. EDSpatient says:

    Without Zofran I would be on TPN (not able to eat any solid food). If the issue is with generics, hey doc, just check the “no substitutions” box and there’s no problem! PLEASE do not take this drug from people who really need it!!!

  31. Diana says:

    My 91 yo mom vomits with any pill whatsoever…always been that way…super sensitive stomach. She’s having colonoscopy in 2 days and the GI doc gave Rx for dolcolax 2 hrs before prep and another Rx for zofran 30 min before prep. She’s 100 lbs. she thinks the pills will make her vomit…shes not concerned about drinking the prep. Is zofran safe for elderly right before a colon prep which will surely throw her electrolytes off & cause dehydration ? Is there a suppository form?

  32. Renee says:

    I realize this is quite an old posting, but it’s information I haven’t heard at all about Zofran.

    I had HG in my two pregnancies. Went “up the ladder” of nausea/vomiting meds, starting with Phenergan, then Compazine, then Reglan (which caused tardive dyskinesia/akathisia episodes that I still suffer effects from, but I didn’t realize what it was and what caused it until several years later).

    Eventually I ended up on the Zofran orally disintegrating tablets (brand name, this was in 2005 (and again in 2007) and the generic was not available yet…and I was also told it was a “new” drug). I had several ECGs in both my pregnancies (and one echocardiogram as well) due to fears of heart damage caused by potassium levels so low I don’t know how I was lucid or my heart was even beating. Every time I had an ECG, I was told they didn’t find any signs of damage but that I did have “non-specific elongation of the QT interval” and that they didn’t know what was causing it, but it would “probably” resolve after giving birth. (I went to school for medical assisting, and had probably a dozen ECGs done during lab practice, none of those ever showed the QT interval elongation. I have not had an ECG since giving birth to my second child, but maybe I should.)

    So now I have to wonder, was the non-specific elongation of the QT interval caused by the low potassium? Electrolyte imbalance? Dehydration? Ketoacidosis? Or was it because I was given Zofran while dehydrated, electrolyte imbalanced, etc?

    I guess this is just one more thing to look back on and be glad that I survived pregnancy and have two healthy children, despite the totally inadequate care, lack of information, and horrible “advice” I received from ER docs, my CNM, the high-risk OB I consulted with, and the on-call OB who took me off PPN and discharged me from the hospital with no meds despite not being able to keep down even water. (He was a real “winner”. He actually told me that instead of trying to drink any liquids, to stay hydrated I should eat cereal, bread, crackers, etc because “they’re carbo*hydrates*! They have ‘hydrate’ right in the name!”)

  33. Oytas says:

    Has anyone using Zofram been diagnosed with AFib?

    • Chris Howell says:

      I have been diagnosed w afib. Dr told me I had two episodes while in the hospital 2 weeks. The salt pills I was given made me sick. He put me on Dialtez 120 Er and now loosing hair

  34. don wascovich says:

    I have been taking Zofran (generic) for several years at dosage of 8 mg 3x/day to treat severe gastroparesis. I am concerned about the long term use. Does anyone know of good studies addressing this issue?

  35. Michelle says:

    The person responsible for this post left out a HUGE detail – the dose. This is what the study actually states,

    “The U.S. Food and Drug Administration (FDA) is informing healthcare professionals and the public that preliminary results from a recently completed clinical study suggest that a 32 mg single intravenous dose of ondansetron (Zofran, ondansetron hydrochloride, and generics) may affect the electrical activity of the heart (QT interval prolongation), which could pre-dispose patients to develop an abnormal and potentially fatal heart rhythm known as Torsades de Pointes.”

    http://www.fda.gov/Drugs/DrugSafety/ucm310190.htm

  36. chris says:

    So no “black box” warning. The 32mg iv single dose used in chemo is now being withdrawn. But the “FDA continues to recommend the intravenous regimen of 0.15 mg/kg administered every 4 hours for three doses to prevent chemotherapy-induced nausea and vomiting. Oral dosing of Ondansetron remains effective for the prevention of chemotherapy-induced nausea and vomiting.”

    http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm330772.htm

    However, in the link at the beginning of this article the FDA says, “Patients at particular risk include those with underlying heart conditions, such as congenital long QT syndrome, those who are predisposed to low levels of potassium and magnesium in the blood, and those taking other medications that lead to QT prolongation.”

    Now, surely anyone suffering from severe vomiting could fall into that electrolyte risk category?? Should they therefore have ECG monitoring as per original FDA advisory?

  37. Laurie says:

    When my daughter and I were taken to the Emergency Room at 3am after vomiting our brains out with food poisoning (highlighted with me puking bile all over the triage nurse), we were both given Zofran intravenously. I can say with great confidence that side effects were the LAST thing on my mind while I was begging for help through a curtain of my bile-dripping hair. I would have paid anything and agreed to (nearly) anything to keep from heaving even one more time. Big Pharma is evil, but desperate times call for desperate measures.

  38. Sherry says:

    Just had shot of zofran and feel 100% better than I have felt in days. The nurse said for me to sit in the waiting room for 30 minutes which has passed with no side effects. Ready to go. Great drug!

  39. Grace says:

    My pregnant daughter was given Zofran and her feet and hands began to swell shortly after, she deveolped a condistion that is very rare called Erythromelalgia, the pain was so excruciating that she was hospialized and put on some very heavy duty pain medications, frightening during pregnancy. I am feeling this all started as a direct result of the Zofran but I do not know how to prove it. I also found out that it in NOT FDA approved to give to pregnant women… Help, ideas

  40. T H says:

    Grace, I’m sorry that your daughter is going through that. Fact of the matter is that there is no evidence-based study (i.e. gold standard double-blinded, placebo-controlled) that is going to help you defend or refute zofran’s use in pregnancy.

    No regulating agency is ever going to approve a study with pregnant women in it.

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