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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?

50 comments

  1. 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?

  2. 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!”)

  3. Has anyone using Zofram been diagnosed with AFib?

    • 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

  4. 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?

  5. 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

  6. 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?

  7. 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.

  8. 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!

  9. 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

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