FDA reports of adverse reaction and side effects from Vimpat/lacosamide
| Tracking # |
2021-7893 FDA2178846 |
| Submitted | Nov. 12, 2021 |
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Communications
From: Shawn Musgrave
To Whom It May Concern:
Pursuant to the Freedom of Information Act, I hereby request the following records:
All reports of adverse events and/or side effects for Vimpat (aka lacosamide), including but not limited to those submitted through the following channels:
-Via the FDA's hotline (1-800-FDA-1088)
-Via the FDA's MedWatch Online Voluntary Reporting Form (https://www.accessdata.fda.gov/scripts/medwatch/)
-Via physical forms submitted by health professionals (FDA Form 3500) and consumers (FDA Form 3500B)
The requested documents will be made available to the general public, and this request is not being made for commercial purposes.
In the event that there are fees, I would be grateful if you would inform me of the total charges in advance of fulfilling my request. I would prefer the request filled electronically, by e-mail attachment if available or CD-ROM if not.
Thank you in advance for your anticipated cooperation in this matter. I look forward to receiving your response to this request within 20 business days, as the statute requires.
Sincerely,
Shawn Musgrave
From: Food and Drug Administration
*** This is an automated message. Please do not reply to this email. ***
Reference: FDA2178846
Dear Requester,
This is to confirm that you submitted a request for record(s) from the Food and Drug Administration
pursuant to the Freedom of Information Act.
FOIA staff will review your request to determine whether it has sufficient information to be processed;
if so, you will receive another email as a formal acknowledgement of your request, with a control number for your request.
If your request is not sufficiently described,
or if there are any other deficiencies with your submission, FOIA staff will contact you via telephone or email.
From: Food and Drug Administration
Control number: 2021-7893
Please find the attached acknowledgement regarding your FOIA request. Note: Do NOT reply directly to this E-mail
From: Food and Drug Administration
A copy of documents responsive to the request.
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Responsive Documents
From: Food and Drug Administration
A copy of documents responsive to the request.
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Responsive Documents
From: Food and Drug Administration
Dear requester,
Attached is your FOIA invoice. Please follow instructions on invoice on how to make payment. If you would like to pay online, please visit https://userfees.fda.gov/pay.
Any questions, please feel free to contact me directly.
Thank you
Kenisha Armstrong
Program Support Specialist
Office of the Executive Secretariat
Division of Freedom of Information
U.S. Food and Drug Administration
Tel: 301-796-9276
Kenisha.Armstrong-Dock@fda.hhs.gov<mailto:Kenisha.Armstrong-Dock@fda.hhs.gov>
Have a great day!
[cid:image002.png@01D8110E.F4DBCED0]<http://www.fda.gov/>
[cid:image004.jpg@01D8110E.F4DBCED0]<https://www.facebook.com/FDA> [cid:image006.jpg@01D8110E.F4DBCED0] <https://twitter.com/US_FDA> [cid:image008.jpg@01D8110E.F4DBCED0] <http://www.youtube.com/user/USFoodandDrugAdmin> [cid:image010.jpg@01D8110E.F4DBCED0] <http://www.flickr.com/photos/fdaphotos/>
Kenisha Armstrong
Program Support Specialist
Office of the Executive Secretariat
Division of Freedom of Information
U.S. Food and Drug Administration
Tel: 301-796-9276
Kenisha.Armstrong-Dock@fda.hhs.gov<mailto:Kenisha.Armstrong-Dock@fda.hhs.gov>
Have a great day!
[cid:image002.png@01D8110E.F4DBCED0]<http://www.fda.gov/>
[cid:image004.jpg@01D8110E.F4DBCED0]<https://www.facebook.com/FDA> [cid:image006.jpg@01D8110E.F4DBCED0] <https://twitter.com/US_FDA> [cid:image008.jpg@01D8110E.F4DBCED0] <http://www.youtube.com/user/USFoodandDrugAdmin> [cid:image010.jpg@01D8110E.F4DBCED0] <http://www.flickr.com/photos/fdaphotos/>
From: Shawn Musgrave
Hello,
Thank you for sending these documents. Two questions:
(1) Can you break down what charges are included in the "Other" category, which accounts for the vast majority of the charge?
(2) Can you provide a fee waiver? I submitted this request as part of a project to request that the DEA re-categorize Vimpat as a non-controlled substance, which will benefit the public considerably. As a person with epilepsy who takes Vimpat, I can attest that the unnecessary categorization of Vimpat as a Schedule V drug places needless obstacles between patients and this vital medication. This data will be included with a formal citizen petition to the DEA to remove Vimpat from the schedule of Controlled Substances. It is also published online in full and was not obtained for any commercial benefit.
Thank you,
Shawn
From: Muckrock Staff
To Whom It May Concern:
I wanted to follow up on the following Freedom of Information Act request, copied below, and originally submitted on Nov. 14, 2021. Please let me know when I can expect to receive a response. You had assigned it reference number #2021-7893.
Thanks for your help, and let me know if further clarification is needed.
From: Food and Drug Administration
Hello,
Please see attached
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2021-7893
Files
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