No more Tigan suppositories

F.D.A. Orders End to Production of a Form of Anti-Nausea Drug – New York Times

F.D.A. Orders End to Production of a Form of Anti-Nausea Drug

By DONALD G. McNEIL Jr.
Published: April 7, 2007

The Food and Drug Administration yesterday ordered drug companies to stop making and selling anti-nausea suppositories containing a drug that the agency said did not work when used in that form.

The move was part of a campaign by the agency to re-evaluate drugs approved before 1962, the year drug makers had to start proving that their products worked. Before 1962, they had to prove only that they did no harm.

The suppositories, sold by prescription under the names Tigan, Tebamide, T-Gen, Trimazide and Trimethobenz, all contain the active ingredient trimethobenzamide.

About two million such suppositories are sold each year, said Dr. Jason Woo, an official in the agency’s compliance office.

Trimethobenzamide in other forms, including pills and injectables, does have F.D.A. approval for use against nausea and vomiting, the agency said.

The agency has had evidence since 1979 that trimethobenzamide suppositories do not work. But the review “requires a lengthy analysis,” Dr. Woo said. Also, the drug makers requested a hearing, “which further slowed the process,” he said.

Hmm, that runs counter to my experience, especially in pediatrics. Interesting.


Comments

  1. Goatwhacker says:

    I have to agree with the FDA on this one. I have had very poor results prescribing Tigan no matter the age group.

  2. juliamd says:

    I have to agree with you GruntDoc, I have had very good success with Tigan suppositories in both pediatrics and adults. I find it a great help in a simple regimen for migraines and as a gentler way of administration for nausea than IV, IM and oral forms of other medications for nausea. Tabbed browsing is a good thing, I now have a window open so I can buy up what remains from eSurg.

  3. Interesting. I’ve used Tigan a fair amount in pediatric vomiting (it’s really all we have) and it seems to do okay. Or, perhaps it’s just placebo effect fooling us all.

  4. TheNewGuy says:

    Is this a joke? Tigan is one of my mainstays of therapy for pediatric vomiting, and I have used it on my own kids with excellent results.

    Hell’s Bells… they took Phenergan away from us for the Is this a joke? Tigan is one of my mainstays of therapy for pediatric vomiting, and I have used it on my own kids with excellent results.

    Hell’s Bells… they took Phenergan away from us for the <2yo cohort, and now Tigan suppositories are off the market. That leaves us with what? What are we supposed to use for the less-than-2 age group? (and I’m sorry, but Emetrol = worthless).

    Guess we’ll have to admit all those young rotavirus cases to the hospital for IV hydration, since we now have almost no anti-emetics left.

  5. To TheNewGuy,

    Don’t forget about Zofran ODT. Yeah, it’s expensive but if it keeps a child with gastroenteritis from being admitted it’s well worth it. Ever since I read this on EMedHome.com I have been using it with great success…

    Ondansetron for Vomiting in Children with Gastroenteritis

    Emergency Physicians are more likely to choose IV over oral rehydration when vomiting is a major symptom of pediatric gastroenteritis (1). In fact, in one survey, 36% of pediatricians reported that vomiting was a contraindication to oral rehydration (3). Use of older antiemetic agents such as promethazine and metoclopramide for vomiting in the setting of pediatric gastroenteritis are less than optimally effective and many have substantial side effects.

    Recent evidence indicates that it is safe to administer oral ondansetron to children, and that a single dose reduces vomiting and facilitates oral rehydration in the Emergency Department (2,4). A single dose of ondansetron improves the success of oral rehydration in dehydrated children with gastroenteritis, resulting in a reduction of more than 50% in both the proportion of children who vomited during oral rehydration and the proportion treated with IV fluids (2).

    A typical weight-based protocol uses orally disintegrating ondansetron tablets: 2 mg for children weighing 8 – 15 kg, 4 mg for children weighing 15 – 30 kg, and 8 mg for children weighing more than 30 kg.

    References:

    (1) Ozuah PO, Avner JR, Stein RE. Oral rehydration, emergency physicians, and practice parameters: a national survey Pediatrics 2002;109:259-261.

    (2) Freedman SB, Adler M, Seshadri R, Powell EC. Oral ondansetron for gastroenteritis in a pediatric emergency department. N Engl J Med 2006 Apr 20;354(16):1698-705.

    (3) Reis EC, Goepp JG, Katz S, Santosham M. Barriers to use of oral rehydration therapy Pediatrics 1994;93:708-711.

    (4) Ramsook C, Sahagun-Carreon I, Kozinetz CA, Moro-Sutherland D. A randomized clinical trial comparing oral ondansetron with placebo in children with vomiting from acute gastroenteritis. Ann Emerg Med 2002;39:397-403.

  6. We don’t have the ODT Zofran, but the IV form can be mixed in a teaaspoon or two of juice and given orally to pedis. I also add it to the GI cocktail in adults with stomach upset.

  7. TheNewGuy says:

    Zofran is a nice option, if you have insurance to pick up the $25 dollar-per-pill price tag.

    I know most of my medicaid moms aren’t going to pay out-of-pocket for that, and my state’s medicaid requires prior authorization, which means 20-30 mintues on the phone.

    Great… thanks FDA.

  8. I just give them one dose to get them out of the ER and through the night; then they can followup with their own doc in the morning.

  9. I too have been using oral zofran since the NEJM study came out about a year ago. I have the nurses put 2mg in the nipple of a pedialyte bottle, and have them take it with 2oz of pedialyte. It’s a one time dose thing.

    Also, zofran went generic earlier this year.

  10. Zofran went generic? Cool! Sorry, OT but I hope that’s going to make a real difference to the way it’s prescribed… how often, at least.

    We have a hospital policy to try certain other drugs first (including metaclopramide) and finishing with ondansetron if the others don’t do the trick. There’s often a certain amount of gentle nudging from the nursing staff in the direction of prescribing ondansetron first, since it’s so effective and we see relatively few adverse effects.

    Haven’t seen or worked with Tigran in this neck of the woods.

  11. John J. Coupal says:

    Dear Dr. [fill in the name]:

    Tigan suppositories have been prescribed for decades. Many doctors have been satisfied with the product’s performance.

    We have just decided that the suppositories don’t work. We are ordering them off the market.

    Sincerely,
    The FDA
    “Your Tax Dollars at Work!”
    Have a nice day.

  12. Gee, it’s always worked in the pediatric population. Now what do we do since Phenergan is no longer an option?

    Granted, not all kids need an antiemetic but how can they say it doesn’t work?

    Not happy at all to read this!

  13. just the ER doc says:

    Listen to the research. If it doesn’t work, it doesn’t work, no matter how much you want it to or think it does. It is placebo effect (which in and of itself is not bad as long as you do not cause side effects). It is like codeine, for which there is ample evidence that it is not more effective than plain tylenol or ibuprofen for pain, and we certainly know that it causes nausea. Darvocet is a similar med, clearly not superior to plain tylenol or ibuprofen. I can’t understand why any doctor would still prescribe these meds unless there is a significant placebo effect in the patient’s mind from previous use of the meds. Dangerous to prescribe meds that don’t work any better than safer and equally effective alternatives.
    That’s my two cents anyway. I’m a young doc, 2 years out of residency, and I’ve never prescribed a tigan suppository in my life. No need to really.

  14. Now let’s watch one of the big drug companies announce a new anti-emetic in the next 6 months… since when does the FDA give a rat’s ass if something is effective?

  15. TheNewGuy says:

    Listen to the research. If it doesn’t work, it doesn’t work, no matter how much you want it to or think it does

    Are you sure about that? Beware… be careful basing your practice on one study or one opinion. The FDA has made some sketchy decisions before, and I’m fairly skeptical that tigan “doesn’t work.” They may have to cone down their study groups a bit, but I’m not buying that it doesn’t work at all. Even if the pharmacological effect is minimal and there’s a big chunk of placebo effect, that’s true for plenty of other medications, and if it helps, it helps. People talk about the placebo effect like it’s some great evil, but it helps your patient, and in that sense, the placebo effect is good.

    Also, I’m aware of the data that shows tylenol#3 and Darvocet are indistinguishable from plain tylenol in blinded studies, and most of the time I’d agree… but I’ve seen clinical situations and patient populations that seem to benefit from those drugs more than you’d think… two examples off the top of my head are tooth pain and little old ladies, respectively.

    Evidence-based medicine is great, but be careful that you don’t worship at that altar so much that you discount the art that only comes from clinical experience.

    But maybe that’s just me getting older and crustier.

  16. tennisdoc says:

    I have been using tigan supps for about 15 years. A few years back medicaid said they weren’t effective. Like darvocet, there are a people who do respond.
    Most of our mothers are in the business of instant gratification.
    Can’t use phenergan, Zofran works, but too expensive. Maybe we can be like the pediatricians, give topical phenergan and tell them to see a different doctor if it doesn’t work.

  17. Paul Miller says:

    What about Prochlorperazine (i.e., Compazine) as an antiemetic? I’m new to this site so forgive me if it’s already been mentioned before. I’ve been given an injection of it in the past for nausea (though they wouldn’t let me drive home!). But I also have Compazine suppositories (25 mg.), which I use a few times per year (if I’m exceedingly nauseated and am afraid for example that taking Phenergan or Tigan orally will take too long to work if I’ve recently eaten a meal).
    Is either Tigan or Phenergan effective (somewhat) for anxiety as well as nausea?
    Would appreciate any advice.
    Paul (forlino@ca.rr.com)

    P.S.: Are there any websites or blogs such as this whereby one can ask a question of a doctor who specializes in inner ear problems? I’m having a frightening problem (which I hope isn’t permanent) after taking the cough syrup Hydromet (hydrocodone + homatropine) which sent me to the E.R. with pressure in one ear that continued to worsen and the fluid never drained.