FDA reports of adverse reaction and side effects from Vimpat/lacosamide (CSV/Excel)
It is a clone of this request.
| Tracking # |
2022-53 FDA2179982 |
| Submitted | Dec. 29, 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.
**NOTE: Please fulfill this request by sending data in CSV/Excel format from the FAERS database, i.e., in its native digital format.** See the attached guidance from FDA CDER indicating that FAERS data is available in CSV/Excel format.
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: FDA2179982
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: 2022-53
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.
-
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@01D8230C.95D8C220]<http://www.fda.gov/>
[cid:image004.jpg@01D8230C.95D8C220]<https://www.facebook.com/FDA> [cid:image006.jpg@01D8230C.95D8C220] <https://twitter.com/US_FDA> [cid:image008.jpg@01D8230C.95D8C220] <http://www.youtube.com/user/USFoodandDrugAdmin> [cid:image010.jpg@01D8230C.95D8C220] <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@01D8230C.95D8C220]<http://www.fda.gov/>
[cid:image004.jpg@01D8230C.95D8C220]<https://www.facebook.com/FDA> [cid:image006.jpg@01D8230C.95D8C220] <https://twitter.com/US_FDA> [cid:image008.jpg@01D8230C.95D8C220] <http://www.youtube.com/user/USFoodandDrugAdmin> [cid:image010.jpg@01D8230C.95D8C220] <http://www.flickr.com/photos/fdaphotos/>
From: Shawn Musgrave
Hello,
This request seeks data in CSV/Excel format, as I made clear in the body of the requests (including with asterisks). Please provide the data in its native format, as required by the FOIA and as the agency has indicated it can do via the Nov. 2014 memo attached to the responsive documents. I will appeal if the agency does not fulfill this request by the end of this week.
Respectfully,
Shawn
From: Food and Drug Administration
Good Afternoon,
This is Andrea Dyson, Regulatory Counsel in the Division of Information Disclosure Policy. This email is in response to your email dated, February 28, 2022, referencing seeking data in CSV/Excel format responsive to FOIA request #2022-53. Please find attached the adverse events and/or side effects for drug Vimpat (Lacosamide) in CSV/Excel format.
Thanks,
Andrea Dyson
T
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Vimpat (Lacosamide) - Detailed Report
From: Food and Drug Administration
Dear Requester,
Our records show that your invoice, as attached, for your FOI request is overdue.
Failure to submit payment, may jeopardize your future request.
If you would like to pay online, please visit https://userfees.fda.gov/pay
Thank you so much,
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:image001.png@01D8E39A.22A99F00]<http://www.fda.gov/>
[cid:image002.jpg@01D8E39A.22A99F00]<https://www.facebook.com/FDA> [cid:image003.jpg@01D8E39A.22A99F00] <https://twitter.com/US_FDA> [cid:image004.jpg@01D8E39A.22A99F00] <http://www.youtube.com/user/USFoodandDrugAdmin> [cid:image005.jpg@01D8E39A.22A99F00] <http://www.flickr.com/photos/fdaphotos/>
From: Shawn Musgrave
Hello,
Thank you for following up. The FDA's invoice does not appropriately enumerate what the charges are for — it only indicates that $61 are being charged for "Other." This is not a category recognized by the FOIA statute. Please advise what these charges are for so that I can determine whether to file an administrative appeal.
Best,
Shawn
From: Shawn Musgrave
Hello,
I received the attached invoice and the email notice below that it was overdue. However, as I wrote to the FOIA Officer, the invoice includes fees that are not allowed under FOIA and does not provide the required level of detail — it indicates that $61 are being charged for "Other" without indicating what "Other" means. Please advise or I will file an administrative appeal by the end of the week, as this is an adverse determination.
Respectfully,
Shawn
From: Food and Drug Administration
Hello- I made the adjustment on the invoice please disregard making payment.
Thank you so much,
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:image001.png@01D8E46A.81C139A0]<http://www.fda.gov/>
[cid:image002.jpg@01D8E46A.81C139A0]<https://www.facebook.com/FDA> [cid:image003.jpg@01D8E46A.81C139A0] <https://twitter.com/US_FDA> [cid:image004.jpg@01D8E46A.81C139A0] <http://www.youtube.com/user/USFoodandDrugAdmin> [cid:image005.jpg@01D8E46A.81C139A0] <http://www.flickr.com/photos/fdaphotos/>
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