11:35 AM | February 22, 2012

Suicidality and Antidepressant Medications

Antidepressant medications increased the risk of suicidal thinking and behavior (suicidality) in children, teens, and young adults. Short-term studies did not show an increase in this risk in adults older than age 24. Suicide is a known risk of depression and some other psychiatric illnesses. Call your doctor right away if you have new or worsening depression, thoughts of suicide, or unusual changes in behavior, particularly during the first few months of treatment or after a change in dose. Families and caregivers of patients who begin antidepressant treatment should watch carefully for any of these signs and should call the doctor right away if these signs appear. For additional important safety information, see Medication Guide on this website.

Privacy Policy

Jazz Pharmaceuticals, Inc. is committed to respecting the personal privacy of our website visitors.

Personal Information Collected

On this website, we only collect such personal information that you choose to submit to us, such as your name, address, telephone number or e-mail address. For example, you may choose to send us an inquiry or concern related to our product or a request for additional materials.

We will only use your personal information to respond to your inquiries, concerns or requests, and in certain circumstances, to get in touch with you when necessary. Your personal information is not disclosed to outside entities other than our partners, contractors or agents working on our behalf to help respond to you, unless we must do so to comply with applicable laws, regulations, court orders or other legal process or to protect our rights or property.

In some cases, we may remove personal identifiers from data and retain it in aggregate form. We may combine this data with other information to produce anonymous, aggregated statistical information helpful to us in improving our products and services.

Please note that we will not intentionally share the contents of any email or form submitted through this website with any third party, except as stated above. However, due to the nature of electronic communications, we cannot and do not provide assurances that the contents will not become known or accessible to third parties.

Traffic Data Collected

When you use this website, we automatically collect certain types of anonymous information, including information about how you use our site (such as pages visited and searches performed), the domain names and/or IP addresses of visitors to our site, time of day the site was visited, and other non-personally identifiable information. Anonymous information is information that is not tied to any individual visitor, but will be useful to us for conducting website analysis and performance review, which will ultimately help us improve our services.

Children

No one under age 13 is allowed to provide any personal information to us. If you are under 13, please do not send any information about yourself to Jazz Pharmaceuticals, including your name, address, telephone number, or email address. In the event that we learn that we have collected personal information from a child under age 13, we will delete that information as quickly as possible.

Links to Other Sites

This website contains links to a number of websites that may offer useful information to our visitors. Jazz Pharmaceuticals is not responsible for the privacy practices or the content of those other sites.

Contacting the Website

If you have any questions about this privacy statement, the practices of this website or your dealings with this website, you may contact:

Jazz Pharmaceuticals
3180 Porter Drive
Palo Alto, CA 94304
Attention: General Counsel

Updates and Changes to Privacy Policy

We reserve the right, at any time to add to, change, update or modify this privacy policy, simply by posting such change, update or modification on the site. Any such change, update or modification will be effective immediately upon posting.

OCD Self-Assessment

What do your obsessions compel
you to do?

Begin

Healthcare Professionals

Get important facts and information about LUVOX CR.

Pharmacist Physician

Questions about LUVOX CR

We're here to help. We welcome your inquiries.

Ask Us

Important Safety Information

Once-A-Day LUVOX CR (fluvoxamine maleate) Extended-Release Capsules are indicated for the treatment of obsessive compulsive disorder (OCD).

Suicidality and Antidepressant Medications

LUVOX CR Capsules and other antidepressant medicines may increase suicidal thoughts and actions in some children, teenagers, and young adults within the first few months of treatment or when the dose is changed.

Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions.

Watch for these changes and call your healthcare provider right away if you notice:

New or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe.
Pay particular attention to such changes when LUVOX CR is started or when the dose is changed.

Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms.

Please see the Medication Guide on this website for additional information on the risk of suicidal thoughts or actions.

WHO SHOULD NOT TAKE LUVOX CR?

Do not take LUVOX CR Capsules if you:

Are allergic to fluvoxamine maleate or any of the ingredients in LUVOX CR Capsules (see the end of the Medication Guide in the full Prescribing Information for a complete list of ingredients in LUVOX CR Capsules).
Take a monoamine oxidase inhibitor (MAOI). Do not take an MAOI within 2 weeks of stopping LUVOX CR Capsules and do not start LUVOX CR Capsules if you stopped taking an MAOI in the last 14 days (2 weeks). People who take LUVOX CR Capsules close in time to an MAOI may have serious, even life-threatening side effects. Get medical help right away if you have any of these symptoms: high fever, uncontrolled muscle spasms, stiff muscles, rapid changes in heart rate or blood pressure, confusion, or loss of consciousness (pass out).
Take any of the following:
- Mellaril^® (thioridazine). Mellaril^® should not be taken with LUVOX CR Capsules because this can cause serious heart rhythm problems or sudden death
- Zanaflex^® (tizanidine) because LUVOX CR can increase the amount of Zanaflex in your body, which could increase its actions and side effects. This could include causing drowsiness and a drop in blood pressure and affecting how well you do things that require alertness.
- The antipsychotic medicine Orap^® (pimozide) because this can cause serious heart problems
- Lotronex^® (alosetron) because LUVOX CR can increase the amount of Lotronex in your body, which could increase its actions and side effects.
- Rozerem^® (ramelteon) because LUVOX CR can increase the amount of Rozerem in your body, which could increase its actions and side effects.

Talk to your doctor if you have any questions.

Always talk with your doctor and pharmacist about any medicines you are taking, including herbal remedies and over-the-counter medicines, for example, aspirin and ibuprofen.

Side Effects

LUVOX CR may cause side effects. In studies, common side effects were nausea, sleepiness, weakness, dizziness, feeling anxious, trouble sleeping, sexual problems, sweating, shaking, not feeling hungry, dry mouth, diarrhea, muscle pain, sore throat, throwing up, upset stomach and yawning. These effects were seen in at least 5% of patients on LUVOX CR and reported twice as often with LUVOX CR as with a sugar pill. In studies, 19% (or nearly one-fifth) of 124 patients with OCD and 26% (more than one-quarter) of 279 patients with another illness left the study early because of side effects.

We encourage you to discuss side effects and any questions regarding LUVOX CR with your doctor.

What should I tell my healthcare provider before taking LUVOX CR?

You should tell your healthcare provider about all of your medical conditions (See Medication Guide on this website), whether you are pregnant, planning to become pregnant or are breastfeeding. Also to avoid a serious and potentially life-threatening condition, tell your healthcare provider if you are taking any of the following:

Other SSRIs or SNRIs, certain migraine or headache medications (triptans)
NSAID pain relievers, aspirin, warfarin, or blood thinners

Do not stop taking LUVOX CR abruptly without first discussing it with your healthcare provider.

LUVOX CR is a registered trademark of Abbott Products, Inc.
CT STEPS is a registered trademark of Jazz Pharmaceuticals, Inc.
SODAS^® is a registered trademark of Elan Pharma International Ltd. (EPIL). US Patent no 7,465,462.

The product information provided in this site is intended for residents of the United States only.

Last update: June 09, 2011