As things have evolved with the recent outbreak of "botulism-like," illness from Botulinum Type A injections in TN and Il, we have put together a comprehensive list of what to do in order to properly report, and have your adverse events evaluated by the key agencies that can assist in providing heptavalent antitoxin.
The following steps are what we recommend people follow, if the adverse events they are experiencing align with iatrogenic botulism, as printed in the manufacturer's patient safety warning label. We recognize that some side effects present differently with intramuscular injections, than what is stated in the warning literature. Therefore, be sure to jot down on your printed copy, ANY similar adverse events next to the ones listed.
We hope that by providing this information to consumers, it will aid those who are suffering severe side effects in being evaluated for appropriate medical interventions, including the use of antitoxin - as quickly as possible.
In addition, we would like regulating bodies to be aware that adverse events that line up with botulism, appear to be happening on a more frequent basis than they are aware of. Then, that this has occurred with regulated product/s and licensed providers of Botulinum Toxin.
These are the following steps our group members have found to be helpful. All steps should be followed in a ONE-TIME sitting. *Ideally, these steps are completed right before heading to the ER.
1. Obtain the batch and/or lot number, product name and expiration date of the product that was administered. You should also obtain the name, address, and phone number of the provider. This will be asked when you make your reports. This will require that you call your provider immediately to request the information. If you are unable to obtain the batch/lot and expiration date, then proceed anyway.
2. Contact the Poison Control 1-800-222-1222 & state, “I believe I have botulism,” if unable to speak, have an advocate call on your behalf. Botulism is a notifiable/reportable condition; therefore, both Poison Control, and your medical providers will need to respond accordingly if/when a consumer has reported and documented their adverse event.
3. Call your local/state health department, plus the CDC to report, & state, “I believe I have botulism.” CDC 1-770-488-7100. If you do not receive a response immediately, you will call the main line, 1-800-CDC-INFO (800-232-4636)
4. Print out copies of the recent State Health Department statements/press releases from the states of Illinois and Tennessee, along with copies of the patient safety warning for the product you received. Here is where you will highlight in all applicable sections, and the adverse events you are experiencing. If your adverse symptoms are similar - but not exact, please write them next to a listed adverse event, that is similar.
If you have received a product other than Botox, it is helpful to print out a copy of the Botox Cosmetic label, as this has a more extensive list of post-marketing adverse event information. This is helpful to show your providers, especially in an emergency room setting, to help then make a proper diagnosis and provide you with necessary supportive testing and treatments.
To print: State Health Department statements/press releases showing "botulism-like," illness has occurred after botulinum toxin A treatments recently, March-April 2024.
Commercial botulinum toxin A patient safety warning labels:
Botox®, Botox Cosmetic®
50 Page Botox Black Box Warning PDF
Dysport®
Xeomin®
Jeuveau®
Myobloc®
Daxxify
Letybo
5. Report online your side effects to the FDA MedWatch: The FDA Safety Information and Adverse Event Reporting Program. Next, you will document ALL the steps you followed above, and send a hard copy (in a letter format,) to the CDC immediately. Then, please keep 2 additional copies, one for your records, and another to be sent to an additional agency downline..more details, TBA.
Possible Form Letter:
Dear CDC,
Hello my name is Jane Doe, I received insert "cosmetic," or "medical," Botulinum Toxin A treatment. My batch and lot number was ____________. My provider's name, address, and phone number are: ____________.
I believe that I have suffered adverse events after treatment that align with what the "insert product name," patient safety warning label states as events that align with botulism. My adverse events are as follows: _____________.
I have called the Poison Control Center and made a report, as well as my local/state health department, to request help on receiving a medical intervention to help ease my adverse events.
In addition, I visited my insert either "provider/s name," and or "emergency room/name of hospital,"(or both, DO list ALL medical providers seen,) to be evaluated. The outcome of my request for a medical intervention was: ____________. (Describe your experience, and outcome.)
Lastly, I have made an online report to the FDA MedWatch, on this date. If you received a case or confirmation number please include that here: __________.
If you have any further questions, or need more information about my experience or adverse event to Botulinum Toxin A, I can be reached at: __________.
Full name
Address
Phone Number
Thank you.
Sincerely,
Jane Doe
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