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Tigan off the market?

Discussion in 'Emergency Medicine' started by edinOH, May 3, 2007.

  1. edinOH

    edinOH Can I get a work excuse? 7+ Year Member

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    Nov 13, 2002
    Apparently this is the case per our hospital pharmacy. Nothing on the web I've found. Anyone else hear this?
     
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  3. 042686

    042686 New Member

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    Yep. From what I've heard, the FDA went back to review drugs like Tigan that it approved prior to the 70's. They didn't find much evidence to support it's intended use and unapproved it. That kinda sucks because I've seen it work like a charm many times.
     
  4. southerndoc

    southerndoc life is good Physician Moderator Emeritus Lifetime Donor Classifieds Approved 10+ Year Member

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    It came across the FDA MedWatch email listserv. (It's a great list to subscribe to.)

    http://www.fda.gov/bbs/topics/NEWS/2007/NEW01601.html

    FDA Announces that Companies Must Stop Marketing Suppository Products Containing Trimethobenzamide

    As part of the Food and Drug Administration's (FDA) on-going initiative to ensure that all marketed U.S. drugs have required marketing approval, the agency announced today that companies must stop manufacturing and distributing unapproved suppository drug products containing trimethobenzamide hydrochloride. These products are used to treat nausea and vomiting in adults and children. Drugs containing trimethobenzamide in suppository form lack evidence of effectiveness. These products have been marketed under various names, including Tigan, Tebamide, T-Gen, Trimazide, and Trimethobenz.

    FDA urges consumers who are using suppositories containing trimethobenzamide, and who have questions or concerns, to contact their health care provider. There are many alternative products approved to effectively treat nausea and vomiting, and that are available in a variety of forms, including tablets, capsules, solutions, injectables and suppositories. Several oral capsules and injectable products containing trimethobenzamide have been approved by FDA and are not affected by today's action.

    "FDA is continuing its work to remove unapproved drugs from the market," said Steven Galson, M.D., M.P.H., director of FDA's Center for Drug Evaluation and Research (CDER). "FDA is committed to ensuring that the medicines Americans rely on when they are sick are proven to be effective and safe."

    The Federal Register notice http://www.fda.gov/OHRMS/DOCKETS/98fr/78n-0224-nwl0002.pdf which outlines the agency's order to manufacturers and distributors, also concludes all outstanding issues for drugs containing trimethobenzamide, under the Drug Efficacy Study Implementation program (DESI). In 1962, Congress amended the Federal Food, Drug, and Cosmetic Act to require that drugs be shown to be effective, as well as safe. Under DESI, FDA evaluated the evidence of effectiveness for thousands of drug products previously approved for safety only, including those products marketed under the name of Tigan containing trimethobenzamide.

    Because DESI findings apply to any unapproved products that are identical, related, or similar to DESI-reviewed drugs, today's notice makes the marketing of any unapproved trimethobenzamide hydrochloride suppository products unlawful.

    "Prescription drugs that have not gone through the FDA approval process are of unproven safety and effectiveness," said director of CDER's Office of Compliance, Deborah M. Autor. "Today's action helps ensure that health care providers prescribe, and consumers take, only medicines shown to be effective."

    Companies manufacturing or marketing trimethobenzamide hydrochloride suppository products must cease shipping them in interstate commerce by May 9, 2007. A small amount of these products will still be available in pharmacies after that date until supplies are exhausted. Any company wishing to market a product containing trimethobenzamide in suppository form must now obtain an approved new drug application prior to marketing.

    This action is the next step in a concerted FDA effort to ensure that all marketed U.S. drugs have required FDA approval. In June of last year, FDA announced its renewed emphasis on this issue and sent a clear signal to industry that FDA expects all marketed drugs to have required FDA approval, and that the agency will take action to make that happen. At that time, FDA published a Compliance Policy Guide or CPG, which is a guidance document that describes the agency's risk-based enforcement approach to marketed unapproved drugs. Completing DESI proceedings is a separate but important part of tackling the unapproved drugs problem.
     
  5. sdn1977

    sdn1977 Senior Member 10+ Year Member

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    Yep - we pulled the suppositories off the shelves. We haven't stocked the capsules in years. The actual recall hasn't been given, so it can still be dispensed, but probably won't be.
     
  6. edinOH

    edinOH Can I get a work excuse? 7+ Year Member

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    Nov 13, 2002
    I never knew they didn't work. Seemed to work well enough for me when I gave them in the department or sent a kid out with them. So much for anecdotal evidence, huh?

    So where do we go from here? Phenergan has a black box for those less than 2 yo I believe and zofran is pretty expensive. I'm not sure medicaid will cover the ODTs.
     
  7. docB

    docB Chronically painful Physician Moderator Emeritus Lifetime Donor Classifieds Approved 10+ Year Member

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    Yeah, it sucks. There's nothing to give parents for the vomiting. And I do mean the parents. The fact that the tigan doesn't work is fine with me. It still gives them something to do while the virus runs out. It's the same as Tamiflu. No American parent leaves the visit without a pill for every ill. Now there's nothing.
     
  8. DocWagner

    DocWagner Senior Member 7+ Year Member

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    This must be a regional phenomena as I prescribed it yesterday with no call from the local pharmacy and it is still in our pyxis.

    Sound like a hospital to hospital basis...last place I worked we could no longer give PHENERGAN IV.
     
  9. docB

    docB Chronically painful Physician Moderator Emeritus Lifetime Donor Classifieds Approved 10+ Year Member

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    Yeah, I've been hearing stuff about that too. I heard it was because it causes lots of tissue damage if it extravasates but I don't know the real reason.
     
  10. EctopicFetus

    EctopicFetus Keeping it funky enough 10+ Year Member

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    Same here in AZ. No more phenergan IV, but zofran is so good.. We still carry the PO version.. but I know you guys would have figured that out.
     
  11. docB

    docB Chronically painful Physician Moderator Emeritus Lifetime Donor Classifieds Approved 10+ Year Member

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    I've quit writing for Zofran as an outpt. I used to write for 5 or 10 tabs to keep the cost down but I just checked with my local pharmacy again and 10 tabs was ~$90. Just not an option for most of my patients. I'm back to writing for phenergan tabs AND suppositories. Gotta give 'em a backup plan.
     
  12. southerndoc

    southerndoc life is good Physician Moderator Emeritus Lifetime Donor Classifieds Approved 10+ Year Member

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    I don't think the word "suppositories" and " give 'em a backup plan" should be used in the same paragraph. :laugh:
     
  13. paramed2premed

    paramed2premed Senior Member 10+ Year Member

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    Nutmeg State
    I read another article describing the other drugs that the FDA is, at long last, getting around to reviewing for effectiveness. Seems like cheap antiemetics and migraine drugs are among the main targets.

    Not to seem too "Loose Change"/black-helicopter, but doesn't it seem funny that the FDA is so aggressive about getting droperidol and Tigan PR off the shelves, while dithering on drugs that seem to have no real advantage beyond price margin?

    Of course, Tigan doesn't have the lobbying juggernaut behind it that Natrecor does.
     

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