WhiteCoat

How Long Before Zofran Gets Black Boxed?

It has been a few years, but the FDA’s war on antiemetics (medications for vomiting) continues.

To review …

Bendectin was the first antiemetic to be taken off the market after famous plaintiff attorney Melvin Belli sued Merrell Dow Pharmaceuticals. No credible evidence was ever found that Bendectin caused birth defects as the plaintiff attorneys alleged, yet Merrell Dow removed bendectin from the market to avoid further lawsuits.
Droperidol was another great nausea medicine that got the FDA’s dreaded “black box” because it allegedly caused QT prolongation. See commentary here.
Then the FDA went after Tigan suppositories. Remove them from the market, it demanded.
Compazine was next to get the dreaded “black box” kiss of death.
Then came Reglan, which joined the “black box” club due to a risk of tardive dyskinesia. Interesting that one of the medications that has been used to treat tardive dyskinesia is another antiemetic … Zofran.
Phenergan was next. In Wyeth v. Levine, a Vermont jury decided that drug labeling warning against intra-arterial use wasn’t strong enough. The resulting black box warning struck fear into the hearts of hospital risk managers everywhere. By the way, how many of you knew that Phenergan is an antihistamine and, like Benadryl, can be used as a local anesthetic?

It appears that not enough people were scared off by the previous FDA warning on Zofran, though.

Now, the FDA has decided the 32 mg IV dose of Zofran has the “potential for serious cardiac risks” and is demanding removal of all 32 mg IV Zofran doses from the market. Those same cardiac risks – QT prolongation – were used to get droperidol black boxed, so it is only a matter of time until Zofran gets its scarlet letter from the FDA.

Personally, I would like to see the FDA’s studies on Zofran … and all the other antiemetics for that matter. I seriously doubt many of the claims.

In the meantime there’s always Aprepitant. That’s only $100/dose (in 2004). Plus … the FDA won’t determine that it’s bad for your health for at least another 10 years – about the time it goes off patent.

19 Responses to “How Long Before Zofran Gets Black Boxed?”

  1. Xsurgerdoc says:

    Yet another reason why we desperately need tort reform centered around a medical court of expert medical professionals to make decisions on med/mal issues based on facts, not “he’s hurt, so somebody must have screwed up”. We have allowed the liberal interpretation of the law by unscrupulous lawyers who are expert at convincing naive, medically ignorant juries to give them what they want, based on a distortion of the facts. We have divorce court, criminal court, traffic court, juvenile court, etc etc ,to settle matters with little or no economic import. A medical court would negate the profit motive and change everything. Check out and support Common Good. Defensive medicine is killing us as well as our patients

  2. kris says:

    I’m buying stock in emesis basins…you are gonna need them.

  3. ThorMD says:

    I’m just curious – how many ED docs use Zofran at the 32 mg dose? I usually give 4-8mg. Sometimes 12 in divided doses if it’s a prolonged ED stay. If someone is still vomiting after that they get Phenergan IM or Ativan IV.

  4. ndenunz says:

    Yeah, don’t inject Phenergan in an artery. Duh. Kinda like don’t spill this hot coffee in your lap.

  5. CJL says:

    Even if they put a black box warning on Zofran, what’s the end effect? I have prescribed, and will continue to prescribe droperidol, Compazine, Reglan, and Phenergan, and I don’t think I”m alone in this. I’m with ThorMD – I’ve never given more than 8 mg of Zofran at a time, although I know that when it’s used for chemotherapy related nausea and vomiting, it’s often given at higher doses.

    I will say, the shortages of IV antiemetics are quite inconvenient (I mean… they’re vomiting, how can they take something by mouth?), but is this related to the black box warning? I don’t know.

    Tell me what I’m missing because right now, I see the black box warning as just that – a warning. We all should be aware of the potential adverse effects of any drug we prescribe anyway, right?

    • WhiteCoat says:

      I still write for Droperidol and Phenergan as well. However, I work at several hospitals. Two of them have removed Droperidol from formulary. One has removed injectable Phenergan. All decisions are because of black box warnings. P&T committees aren’t as rational as those prescribing the medications.
      I don’t give more than 8mg of Zofran at a time, either, but with the FDA noting that there is a relationship between dose and alleged QT prolongation, it is only a matter of time.
      Then if you use Zofran and your patient happens to be one of the 1 in a million that has a bad outcome, you’re screwed. Black Box warning will be Exhibit #1 at trial.
      Like winning the lottery – only in reverse.

  6. Leslie says:

    I use Phenergan regularly (for my migraine nausea) and during an EKG last year (pre-op testing) they discovered some QT prolongation.

    After a cardio stress test, the cardiologist blamed it on the Phenergan.

    By the way, I knew Phenergan was an antihistamine and I am not in the medical field.

    • Jay says:

      Pharmaceutical induced QT prolongation is idiosyncratic and not always dose dependent. Unless you had taken phenergan within several drug half life’s prior to your treadmill test, it is far from certain that your QT prolongation was phenergan induced.

  7. Ryan Kane says:

    Hey WC,
    Just wanted to let you know that I love your blog, and mostly your Healthcare updates! I referenced you in my blog, by the way. I used some of your healthcare updates when discussing my solutions to the Fiscal Cliff.

    http://externalpolitics.wordpress.com/2012/12/05/the-ideal-budget/

    You’re mentioned in the end!

    Sincerely,

    Ryan

  8. Stephanie says:

    So what are patients like me, who can’t have Phenergan or Reglan due to seizure like reactions, supposed to do? I’ve taken Zofran for years due to GERD with Nissen repair complications. Even after surgery the highest does I’ve ever recieved at once has been 12mg. Of course I took Propulsid and Vioxx for years before the FDA pulled those and never had an issue with either one.

    • WhiteCoat says:

      Pay full price for the new nausea medicine that will probably hit the market in the near future?
      Ginger root is good for nausea – until the FDA bans that as being unregulated or some damn thing.

  9. Briana says:

    This stuff scares me. During my pregnancy I had hyperemesis and antiemetics saved my life/sanity.

    My daughter is 4 now and I’m thinking about trying pregnancy again. One of my biggest fears is that I won’t be able to get the medications this time around.

  10. Steve says:

    As I’ve said before on here (and later published in EP monthly) it’s likely because they have a new antiemetic in the pipeline and they want people to have to use that instead. It’s droperidol part 2

    Another consideration- I’m wondering if this is an attempt to keep zofran from OTC status. Zofran is truly safer than tylenol (no one ever died or needed a new liver from taking too much zofran) and the OTC need for it is huge. But OTC status can mean less money for the manufacturer so this may be their way of fighting it.

  11. Max Kennerly says:

    Oh no, not a warning on the package! If that happens, why, doctors might know what they’re prescribing to patients.

  12. PreggyRNx4 says:

    I take Zofran to control my pregnancy related nausea and vomiting, it’s been a wonder drug for me! I have never been able to work while pregnant before because my symptoms were so horrible. My aunt, who is a NP, tells me last night birth defects are being associated with Zofran use and Reglan is now being prescribed. I can’t find anything on the FDA website that concurs with this. It sounds like you are all on board with continuation of prescribing Zofran, and given the lack of information on why pregnant woman should avoid use I am thinking it would be ok to continue. Am I insanely wrong here?

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