[Posted 12/14/2012] ISSUE: FDA notified healthcare professionals and the public on the use of selective serotonin reuptake inhibitor (SSRI) antidepressants by women during pregnancy and the potential risk of a rare heart and lung condition known as Persistent Pulmonary Hypertension of the Newborn (PPHN). The initial Public Health Advisory in July 2006 on this potential risk was based on a single published study. Since then, there have been conflicting findings from new studies evaluating this potential risk, making it unclear whether use of SSRIs during pregnancy can cause PPHN.
FDA has reviewed the additional new study results and has concluded that, given the conflicting results from different studies, it is premature to reach any conclusion about a possible link between SSRI use in pregnancy and PPHN. FDA will update the SSRI drug labels to reflect the new data and the conflicting results.
BACKGROUND: SSRIs are marketed under various brand and generic drug names, and are used to treat depression and other psychiatric disorders. There are no adequate and well-controlled studies of SSRIs in pregnant women.
PPHN occurs when a newborn baby does not adapt to breathing outside the womb. Newborns with PPHN may require intensive care support including a mechanical ventilator to increase their oxygen level. If severe, PPHN can result in multiple organ damage, including brain damage, and even death.
RECOMMENDATION: FDA advises health care professionals not to alter their current clinical practice of treating depression during pregnancy. See the Data Summary in the FDA Drug Safety Communication for additional information. FDA will communicate any new information on the risk of bleeding and dabigatran when it becomes available. For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety.
A small number of children, teenagers, and young adults (up to 24 years of age) who took antidepressants ('mood elevators') such as vilazodone during clinical studies became suicidal (thinking about harming or killing oneself or planning or trying to do so). Children, teenagers, and young adults who take antidepressants to treat depression or other mental illnesses may be more likely to become suicidal than children, teenagers, and young adults who do not take antidepressants to treat these conditions. However, experts are not sure about how great this risk is and how much it should be considered in deciding whether a child or teenager should take an antidepressant. Children younger than 18 years of age should not normally take vilazodone, but in some cases, a doctor may decide that vilazodone is the best medication to treat a child's condition.
You should know that your mental health may change in unexpected ways when you take vilazodone or other antidepressants, even if you are an adult over 24 years of age. You may become suicidal, especially at the beginning of your treatment and any time that your dose is increased or decreased. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms: new or worsening depression; thinking about harming or killing yourself, or planning or trying to do so; extreme worry; agitation; panic attacks; difficulty falling asleep or staying asleep; aggressive behavior; irritability; acting without thinking; severe restlessness; frenzied abnormal excitement; or any other changes in your usual thoughts, mood, or behavior. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor if you are unable to seek treatment on your own.
Your healthcare provider will want to see you often while you are taking vilazodone, especially at the beginning of your treatment. Be sure to keep all appointments for office visits with your doctor.
Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with vilazodone and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.
No matter your age, before you take an antidepressant, you, your parent, or your caregiver should talk to your doctor about the risks and benefits of treating your condition with an antidepressant or with other treatments. You should also talk about the risks and benefits of not treating your condition. You should know that having depression or another mental illness greatly increases the risk that you will become suicidal. This risk is higher if you or anyone in your family has or has ever had bipolar disorder (mood that changes from depressed to abnormally excited) or mania (frenzied, abnormally excited mood) or has thought about or attempted suicide. Talk to your doctor about your condition, symptoms, and personal and family medical history. You and your doctor will decide what type of treatment is right for you.
Vilazodone is used to treat depression. Vilazodone is in a class of medications called selective serotonin reuptake inhibitors (SSRIs) and is also a 5HT1A receptor partial agonist. It works by increasing the amount of serotonin, a natural substance in the brain that helps maintain mental balance.
Vilazodone comes as a tablet to take by mouth. It is usually taken with food once a day. Take vilazodone at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take vilazodone exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Your doctor will probably start you on a low dose of vilazodone and gradually increase your dose, not more than once every 7 days.
Vilazodone controls depression but does not cure it. It may take several weeks before you feel the full benefit of vilazodone. Continue to take vilazodone even if you feel well. Do not stop taking vilazodone without talking to your doctor. Your doctor will probably decrease your dose gradually. If you suddenly stop taking vilazodone, you may experience withdrawal symptoms such as dizziness; nausea; headache; confusion; irritability; agitation; difficulty falling asleep or staying asleep; anxiety; extreme tiredness; seizures; pain, burning, or tingling in the hands or feet; or sweating. Tell your doctor if you experience any of these symptoms while you are decreasing your dose of vilazodone or soon after you stop taking vilazodone.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medication.
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
dry mouth
increased appetite
heartburn
gas
dizziness
pain, burning, or tingling in the hands or feet
uncontrollable shaking of a part of the body
unusual dreams
tiredness
joint pain
changes in sexual desire or ability
rash
hives
swelling
difficulty breathing
loss of consciousness
seizures
fever, sweating, confusion, fast or irregular heartbeat, and severe muscle stiffness
diarrhea
nausea
vomiting
unusual bleeding or bruising
nosebleeds
small red or purple dots on the skin
hallucinations (seeing things or hearing voices that do not exist)
headache
difficulty concentrating
memory problems
weakness
problems with coordination
increased falls
fainting
Vilazodone may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
fever, sweating, confusion, fast or irregular heartbeat, and severe muscle stiffness
hallucinations (seeing things or hearing voices that do not exist)
lack of energy
restlessness
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
Last Revised - 02/15/2012
AHFS® Consumer Medication Information. © Copyright, 2012. The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.