Drug Safety Information for VIMPAT (Lacosamide)

Safety-related Labeling Changes for VIMPAT (LACOSAMIDE) Rx Drug: FDA Link

Required post-approval safety study:

A safety study of replacement of oral dosing with intravenous dosing administered over 30 to 60 minutes in pediatric patients > or equal to 1 month to < 17 years of age with partial-onset seizures. If safety is acceptable, a replacement study at a faster rate of infusion (15 minutes) must be conducted in this population. Sparse PK samples must be collected to evaluate the pharmacokinetics of lacosamide and its metabolite using PPK approach in this population. Due Date: 2021-09-30

Required post-approval safety study:

Original FDA Drug Approval Date for VIMPAT: 2008-10-28

Adverse Drug Reactions for VIMPAT* (Lacosamide)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with VIMPAT
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Convulsion	1288
2	Dizziness*	325
3	Drug ineffective	309
4	Fatigue	227
5	Somnolence*	220
6	Grand mal convulsion	212
7	Status epilepticus	209
8	Fall	199
9	Nausea*	185
10	Vomiting	172
11	Drug interaction	167
12	Epilepsy	159
13	Headache	156
14	Overdose	145
15	Balance disorder*	145
16	Diplopia	141
17	Off label use	140
18	Death	136
19	Gait disturbance	127
20	Depression*	125

* This side effect also appears in "Top 10 Side Effects of VIMPAT " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking VIMPAT
(associated with FDA Medwatch/FAERS Reports)

	Reason	# of FDA Reports
1	Epilepsy*	4220
2	Convulsion*	4118
3	Product used for unknown indication	1678
4	Partial seizures*	849
5	Status epilepticus	320
6	Complex partial seizures	294
7	Grand mal convulsion	126
8	Off label use	102
9	Convulsion prophylaxis	92
10	Temporal lobe epilepsy	48

*Also a top-10 reason in AskaPatient Review Summary.

Types of Adverse Events for VIMPAT

Total Reports Filed with FDA: 17932

Number of FDA Adverse Event Reports by Patient Age for VIMPAT

Total Reports Filed with FDA: 17932*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Lacosamide (Vimpat)

Charts are based on 17932 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.