Talk:Botulism

Thoughts on this text?

"The public can research botulism and adverse events related to botulinum toxin injectables that were reported to the FDA (Food and Drug Administration) at no charge by accessing the FAERS database. As of October 2019, the query executed as "botulinum toxin" in the FDA Adverse Event Reporting System (FAERS) database generated 50,000 adverse reports; some included botulism and death."

Added 4 times now? Doc James (talk · contribs · email) 20:12, 6 December 2019 (UTC)

have reverted, agree with above editor --Ozzie10aaaa (talk) 22:12, 6 December 2019 (UTC)

Why would you want to deprive wiki users to access of the records of reported iatrogenic botulism cases? Please explain who is helped by withholding this knowledge? Skye Bravo (talk) 02:51, 8 December 2019 (UTC)Skye Bravo

We do not generally link to searches. Doc James (talk · contribs · email) 01:24, 9 December 2019 (UTC)

Where/how do you suggest the existence of the FDA searchable database be placed in the botulism article so that curious people who want to researh botulism through the FDA FAERS system can at least know it exists. They can run their own search results. Skye Bravo (talk) 02:30, 29 December 2019 (UTC)

Iatrogenic botulism

Source says

"Iatrogenic botulism. Iatrogenic botulism is caused by injection of botulinum toxin for cosmetic or therapeutic purposes. Doses recommended for cosmetic treatment are too low to cause systemic disease. Higher doses injected for treatment of muscle movement disorders have caused anecdotal cases of systemic botulism-like symptoms [34]. Injection of unlicensed, highly concentrated botulinum toxin caused severe botulism in 4 patients who received it for cosmetic purposes (unpublished data)"

as for the (unpublished data) sentence, we can cite that with these two papers: Daniel S. Chertow, MD was the lead author on the paper covering the Florida tragedy. It is available as a free PDF, which is nice access for wikipedia users who want to research the citations. Chertow is from the NIH. Chertow, D. S., Tan, E. T., Maslanka, S. E., Schulte, J., Bresnitz, E. A., Weisman, R. S., ... & Sobel, J. (2006). Botulism in 4 adults following cosmetic injections with an unlicensed, highly concentrated botulinum preparation. Jama, 296(20), 2476-2479. https://scholar.google.com/scholar?hl=en&as_sdt=0%2C5&q=Botulism+in+4+adults+following+cosmetic+injections+with+an+unlicensed%2C+highly+concentrated+botulinum+preparation&btnG=

Here is another paper on one of the four patients in Florida who got botulism from lab grade botulinum toxin. A horrific narrative, but very creative and effective...because the writing format alternates between the physician and the patient. Marcus, Steven M. "Screams from a Glass Coffin." In Medical Toxicology: Antidotes and Anecdotes, pp. 57-69. Springer, Cham, 2017. Skye Bravo (talk) 04:26, 9 December 2019 (UTC) Skye Bravo (talk) 04:26, 9 December 2019 (UTC)

Doc James (talk · contribs · email) 01:06, 8 December 2019 (UTC)

This is NOT an accurate assumption: "Doses recommended for cosmetic treatment are too low to cause systemic disease" 13 Neurologists at the NIH, including Dr. Mark Hallett, diagnosed a 50 units dose of Botox Cosmetic as the source of iatrogenic botulism, based on a patient interview in person and a chart review. Unpublished data, but documented on NIH letterhead. Skye Bravo (talk) 02:49, 8 December 2019 (UTC)Skye Bravo

We generally go by what sources says. Doc James (talk · contribs · email) 01:25, 9 December 2019 (UTC)

Please review this article: Bai, Lili, Xiaobo Peng, Yanqing Liu, Yawei Sun, Xin Wang, Xingwang Wang, Guodong Lin et al. "Clinical analysis of 269 botulism cases caused by cosmetic injection of botulinum neurotoxin." Toxicon 158 (2019): S15. Skye Bravo (talk) 04:15, 9 December 2019 (UTC)

Also, the prescribing information specifically mentions "botulism" on page 47.

//media.allergan.com/actavis/actavis/media/allergan-pdf-documents/product-prescribing/20190620-BOTOX-100-and-200-Units-v3-0USPI1145-v2-0MG1145.pdf

Skye Bravo (talk) 02:49, 8 December 2019 (UTC)Skye Bravo

the terminology "anecdotal cases" sounds as if it is folklore, yet there are many cases documented in the literature. One that comes to mind is Dr. You's case in New Jersey in 2016. The patient was injected with 80 Units of Botox to aid in swallowing, she experienced severe botulism THE SAME DAY, which is shocking. The CDC provided antitoxin to her yet she remained in ICU for months and later died. Her lab tests later confirmed she had botulism, mouse or mass spec they did not indicate which one. This was an off-label use, but it does show how low doses can cause systemic botulism. Article: "Rapidly Progressive Muscle Paralysis and Acute Respiratory Failure Following Endoscopic Botulinum Toxin Injection" Geoffrey You,MD. Skye Bravo (talk) 02:49, 8 December 2019 (UTC)Skye Bravo

Since it seems from what you write that there are lots of reported cases, aren't there any review that covers a significant set of these cases? Even if they are not clinical trials (which is difficult for adverse effects), a review would at least provide a "bigger picture" view on the matter. --Signimu (talk) 23:20, 8 December 2019 (UTC)

See WP:MEDRS

This case report is NOT about cosmetic use Doc James (talk · contribs · email) 01:26, 9 December 2019 (UTC)

A dose under 100 units is generally considered a "low dose" and a cosmetic dose, though the FDA approval is for 20 units. Skye Bravo (talk) 04:05, 9 December 2019 (UTC)

We simple go by what high quality references say. Doc James (talk · contribs · email) 21:43, 9 December 2019 (UTC)

Would the FDA communication be considered a high quality reference? ^[1] To quote: "FDA has received reports of systemic adverse reactions including respiratory compromise and death following the use of botulinum toxins types A and B for both FDA-approved and unapproved uses. The reactions reported are suggestive of botulism, which occurs when botulinum toxin spreads in the body beyond the site where it was injected. The most serious cases had outcomes that included hospitalization and death,..... These serious systemic adverse reactions occurred following treatment of a variety of conditions using a wide range of botulinum toxin doses." Skye Bravo (talk) 02:22, 29 December 2019 (UTC)

Other countries are more open about COSMETIC BoNT injections causing iatrogenic botulism, so perhaps it would be useful to the global audience to include those perspectives? Skye Bravo (talk) 02:25, 29 December 2019 (UTC) Example below:

Toxicon Journal: ••••••••••••••••••••••• CLINICAL ANALYSIS OF 269 BOTULISM CASES CAUSED BY COSMETIC INJECTION OF BOTULINUM NEUROTOXIN Lili Bai, Xiaobo Peng, Yanqing Liu, Yawei Sun, Xin Wang, Xingwang Wang, Guodong Lin, Shufang Feng, Peng Zhang, Kun Wan, Zewu Qiu* . Department of Poisoning Treatment, Afliated Hospital, Academy of Military Medical Science, Poisoning Treatment Center of the Army, Beijing, China *

Abstract Objective: This study was conducted to analyze the clinical characteristics and treatment methods of botulism among patients receiving cosmetic injection of BoNT. Methods: A total of 269 botulism patients due to cosmetic injection of BoNT were enrolled in our study. Botulism diagnosis was according to cosmetic BoNT use history, clinical symptoms, and auxiliary examinations. All the patients received comprehensive and antitoxin treatments. Chisquare test was applied to estimate the association between injection dose of BoNT and severity of botulism.

Results: The clinical symptoms of botulism occurred within 0-36 days after BoNT injection, especially on the 2nd to 6th days. 78 cases (29%) presented mild botulism, 110 patients (41%) presented moderate botulism, and the remaining 81 cases (30%) developed severe botulism.

Furthermore, the injection dose of BoNT was positively correlated with severity of botulism (P ¼ 0.001). Patients with more than 200 U BoNT injection were more likely to undergo severe botulism. The botulism symptoms of the cases relieved or disappeared when discharged. Conclusion: The injection dosage of BoNT should be strictly controlled to minimize the occurrence of botulism. Once botulism occurs, timely and appropriate treatments are critical to improve the outcomes of the cases.Skye Bravo (talk) 02:25, 29 December 2019 (UTC)