Drug Safety Information for FETZIMA (Levomilnacipran hydrochloride)

FDA Safety-related Labeling Changes for FETZIMA (LEVOMILNACIPRAN HYDROCHLORIDE) Rx Drug: Safety Information Link

Required post-approval safety study:

A deferred pediatric study under PREA for the treatment of major depressive disorder in pediatric patients ages 12 to 17 years. Conduct a study to obtain data on the pharmacokinetics (PK), efficacy and safety of levomilnacipran in the relevant adolescent population (ages 12 to 17 years). This study must be a placebo-and active-controlled (escitalopram or fluoxetine) fixed-dose study. You should submit data from population PK modeling in adults to justify dose selection and PK sampling schedule for this adolescent study, at least 3 months prior to submitting the protocol. When the appropriate number of PK samples becomes available from this adolescent study (PMR#1943-1), an interim population PK analysis should be conducted to determine the dosing and regimen for the second efficacy and safety study in children and adolescents (ages 7-17 years). Due Date: 2020-05-19

Original FDA Drug Approval Date for FETZIMA: 2013-07-25

Adverse Drug Reactions for FETZIMA* (Levomilnacipran hydrochloride)

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 FETZIMA
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Suicidal ideation	24
2	Headache	17
3	Nausea	14
4	Blood pressure increased	14
5	Dizziness	13
6	Hyperhidrosis	13
7	Drug ineffective	12
8	Urinary retention	12
9	Depression	11
10	Vomiting	10
11	Off label use	10
12	Serotonin syndrome	9
13	Suicide attempt	9
14	Anxiety	7
15	Intentional overdose	7
16	Heart rate increased	7
17	Feeling abnormal	7
18	Palpitations	7
19	Urinary hesitation	6
20	Agitation	6

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

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

	Reason	# of FDA Reports
1	Depression	270
2	Major depression	71
3	Product used for unknown indication	60
4	Antidepressant therapy	15
5	Cerebrovascular accident	12
6	Fibromyalgia	4
7	Seasonal affective disorder	4
8	Bipolar disorder	2
9	Bipolar i disorder	1

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

Types of Adverse Events for FETZIMA

Total Reports Filed with FDA: 646

Number of FDA Adverse Event Reports by Patient Age for FETZIMA

Total Reports Filed with FDA: 646*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Levomilnacipran hydrochloride (Fetzima)

Charts are based on 646 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.