Legal Notice

Forest Laboratories, Inc., and its subsidiaries, ("Forest") operate certain Web sites (the "Forest Websites") for the purpose of personal information and education. The health information contained in the Forest Websites is provided for educational purposes only and is not intended to replace discussions with a physician or other healthcare provider. Your use of a Forest Website constitutes your acceptance without modification of the terms, conditions, and notices contained herein and all applicable laws. Your use of a particular Forest Website included within the Forest Websites network may also be subject to additional terms outlined elsewhere on that Website.

Use of Site

Forest hereby authorizes you to copy documents published by Forest on the World Wide Web for noncommercial use by you or your organization only, provided any copy of these documents you make shall retain all copyright and other proprietary notices contained therein.

Nothing contained herein shall be construed as conferring, by implication, estoppel, or otherwise, any license or right under any patent or trademark of Forest or any third party. Except as expressly provided above, nothing contained herein shall be construed as conferring any license or right under any Forest copyright.

Should any viewer of a Forest published document respond with information including feedback data, such as questions, comments, suggestions, or the like regarding the content of any such Forest document, such information shall be deemed to be non-confidential, and Forest shall have no obligation of any kind with respect to such information and shall be free to reproduce, use, disclose, and distribute the information to others without limitation. Forest shall be free to use any ideas, concepts, know-how, or techniques contained in such information for any purpose whatsoever including but not limited to developing, manufacturing, and marketing products incorporating such information.

Claims

Each claim or statement about the safety or effectiveness of Forest products and each claim or statement comparing the safety or effectiveness of Forest products to the safety or effectiveness of other products is expressly limited to the United States, unless otherwise disclosed on the Website.

Third-Party Links

In an attempt to provide increased value to our visitors, the Forest Websites may contain links to other Websites on the Internet that are owned and operated by third-party vendors and other third parties. However, even if the third party is affiliated with Forest, Forest has no control over these linked Websites, all of which have separate privacy and data collection practices independent of Forest. Forest makes no claim or representation regarding, and accepts no responsibility for the quality, content, nature, or reliability of Websites accessible by hyperlink from the Forest Websites or Websites linking to the Forest Websites. The linked Websites are not under the control of Forest, and Forest is not responsible for the contents of any linked Website or any link contained in a linked Website, or any review, changes or updates to such Web sites. Forest is providing these links to you only as a convenience, and the inclusion of any link does not imply affiliation, endorsement, or adoption by Forest of the Website or any information contained therein. These linked Web sites are only for your convenience, and, therefore, you access them at your own risk.

Disclaimer and Limitation of Liability

Forest makes no warranties or representations about the accuracy or completeness of the Forest Website's content or the content of any linked Websites. This publication is provided "AS IS" WITHOUT WARRANTY OF ANY KIND, EITHER EXPRESSED OR IMPLIED, INCLUDING , BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR NON-INFRINGEMENT. FOREST DOES NOT REPRESENT OR WARRANT THAT MATERIALS ON THIS WEBSITE ARE ACCURATE, COMPLETE, RELIABLE, CURRENT, OR ERROR-FREE. FOREST DOES NOT REPRESENT OR WARRANT THAT THIS WEBSITE OR ITS SERVER(S) ARE FREE OF VIRUSES OR OTHER HARMFUL COMPONENTS. Some jurisdictions do not allow the exclusion of implied warranties, so the above exclusion may not apply to you.

IN NO EVENT SHALL FOREST BE LIABLE FOR ANY DIRECT, SPECIAL, INDIRECT, OR CONSEQUENTIAL DAMAGES, OR ANY OTHER DAMAGES OF ANY KIND INCLUDING, BUT NOT LIMITED TO, LOSS OF USE, LOSS OF PROFITS, OR LOSS OF DATA, WHETHER IN AN ACTION IN CONTRACT, TORT (INCLUDING, BUT NOT LIMITED TO, NEGLIGENCE), OR OTHERWISE, ARISING OUT OF OR IN ANY WAY CONNECTED WITH THE USE OF THIS WEBSITE OR THE MATERIALS CONTAINED ON, OR ACCESSED THROUGH, THIS WEBSITE.

Applicable Law

These terms and conditions shall be governed by and construed in accordance with the laws of the State of New York, without regard to its choice of law principles.

IMPORTANT SAFETY INFORMATION

WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS

Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of VIIBRYD or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. VIIBRYD is not approved for use in pediatric patients.

Contraindications

Serotonin Syndrome and MAOIs: Do not use MAOIs intended to treat psychiatric disorders with VIIBRYD or within 14 days of stopping treatment with VIIBRYD. Do not use VIIBRYD within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start VIIBRYD in a patient who is being treated with linezolid or intravenous methylene blue.

Warnings and Precautions

All patients treated with antidepressants should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the first few months of treatment and when changing the dose. Consider changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse or includes symptoms of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania, mania, or suicidality that are severe, abrupt in onset, or were not part of the patient's presenting symptoms. Families and caregivers of patients being treated with antidepressants should be alerted about the need to monitor patients daily. Prescriptions for VIIBRYD should be written for the smallest quantity of tablets consistent with good patient management, in order to reduce the risk of overdose.
Serotonin Syndrome: The development of a potentially life-threatening serotonin syndrome has been reported with SNRIs and SSRIs, including VIIBRYD, both when taken alone, but especially when co-administered with other serotonergic agents (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John’s Wort) and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue). Symptoms of serotonin syndrome may include mental status changes (eg, agitation, hallucinations, delirium, and coma), autonomic instability (eg, tachycardia, labile blood pressure, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (eg, tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and/or gastrointestinal symptoms. If symptoms of serotonin syndrome occur, discontinue VIIBRYD and initiate supportive treatment. If concomitant use of VIIBRYD with other serotonergic drugs is clinically warranted, patients should be aware of a potential increased risk for serotonin syndrome, particularly during treatment initiation and dose increases. Patients should be monitored for the emergence of serotonin syndrome.
Like other antidepressants, VIIBRYD should be prescribed with caution in patients with a seizure disorder.
The use of drugs that interfere with serotonin reuptake, including VIIBRYD, may increase the risk of bleeding events. Patients should be cautioned about the risk of bleeding associated with the concomitant use of VIIBRYD and NSAIDs, aspirin, warfarin, or other drugs that affect coagulation or bleeding.
Symptoms of mania/hypomania were noted in 0.1% of patients treated with VIIBRYD in clinical studies. As with all antidepressants, VIIBRYD should be used cautiously in patients with a history or family history of bipolar disorder, mania, or hypomania.
Prior to initiating treatment with an antidepressant, patients with depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder. VIIBRYD is not approved for use in treating bipolar depression.
Discontinuation symptoms have been reported with discontinuation of serotonergic drugs such as VIIBRYD. Gradual dose reduction is recommended, instead of abrupt discontinuation, whenever possible. Monitor patients when discontinuing VIIBRYD. If intolerable symptoms occur following a dose decrease or upon discontinuation of treatment, consider resuming the previously prescribed dose and decreasing the dose at a more gradual rate.
Advise patients that if they are treated with diuretics, or are otherwise volume depleted, or are elderly, they may be at greater risk of developing hyponatremia while taking VIIBRYD. Although no cases of hyponatremia resulting from VIIBRYD treatment were reported in the clinical studies, hyponatremia has occurred as a result of treatment with SSRIs and SNRIs. Discontinuation of VIIBRYD in patients with symptomatic hyponatremia and appropriate medical intervention should be instituted.

Adverse Reactions

The most commonly observed adverse reactions in MDD patients treated with VIIBRYD in placebo-controlled studies (incidence ≥5% and at least twice the rate of placebo) were: diarrhea (28% vs 9%), nausea (23% vs 5%), insomnia (6% vs 2%), and vomiting (5% vs 1%).

Please also see full Prescribing Information