Celexa (citalopram hydrobromide) is a prescription antidepressant. It belongs to the SSRI or Selective Serotonin Reuptake Inhibitors class of medications. After taking this medication, a person may feel an improved energy level and feelings of well-being.

Prescription Name and Overview

Celexa or citalopram is used to treat depression. It belongs to a class of antidepressants called SSRIs or Selective Serotonin Reuptake Inhibitors which works by increasing the amount of serotonin in the brain and help maintain mental balance.

Celexa comes as a tablet with 10 mg, 20 mg, and 40 mg strengths. This medication is taken orally, usually once a day, with or without food. It may take 1-4 weeks for a person to feel the full benefit of Celexa.

Generic Name and Overview

Citalopram is available in generic form. It became available in 2003, after the patent with Forest Laboratories expired, allowing other pharmaceutical companies to legally manufacture generic versions of Celexa.

OTC  Name and Overview

Celexa is not an over-the-counter medication and is only available under a doctor’s prescription.

Manufacturer

Celexa is manufactured by Forest Laboratories.

Labeled Indications

Celexa is indicated for the treatment of depression.

The efficacy of Celexa in the treatment of depression was established in 4-6 week, controlled trials of outpatients whose diagnosis corresponded most closely to the DSM-III and DSM-III-R category of major depressive disorder.

Active Ingredients

Celexa contains the active ingredient citalopram hydrobromide.

What Is It Used For?

Celexa is indicated to treat depression.

How Does it Work?

Antidepressants that belong to the SSRI class work by increasing the activity in the mood centers of the brain. The activity is centered on a chemical messenger, serotonin, which acts to regulate sleep and mood and provides the feeling of satisfaction.

What are the Approved Uses?

Celexa is approved for the treatment of major depressive disorder but is also used off-label for treatment of anxiety, obsessive-compulsive disorder, and eating disorders. It has also been used by other physicians as medication for diabetic neuropathy, a degenerative nerve condition which causes extreme pain in people with diabetes.

Celexa is only approved to treat depression that has symptoms such as:

• Loss of interest to participate in normal activities
• Feelings of guilt or worthlessness
• Excessive crying
• Lethargic/ lack of energy
• Difficulty concentrating
• Changes in appetite
• Changes in sleep patterns
• Suicidal thoughts and tendencies

Production Anecdotes / History

Celexa was approved by the FDA to treat major depressive disorder in adults in July 1998. It has not been approved for pediatric use.

Citalopram was first synthesized in 1972 by a group of researchers under the leadership of chemist Klaus Bøgesø. It was first marketed in Denmark in 1989 by Lundbeck and was approved to be manufactured in the United States in 1998. It was intended to be an improvement of the older SSRIs (Prozac, Zoloft, Paxil).

Precautions

Some precautions before taking Celexa:

• Inform your doctor if you are allergic to citalopram, escitalopram, or to any of the ingredients found in the Celexa tablet.
• Inform your doctor about the other drugs you are taking, especially if you are taking pimozide (Orap) or a monoamine oxidase (MAO) inhibitor such as isocarboxazid (Marplan), linezolid (Zyvox), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate), or if you have stopped taking an MAO inhibitor within the past 14 days. Your doctor will probably ask you to wait for 14 more days before you start to take an MAO inhibitor.
• Don’t take Celexa with escitalopram (Lexapro). They are very similar to each other and should not be taken together.
• Inform your doctor of any other medications, nutritional supplements, vitamins, and herbal products you are taking or are planning to take. These may interact with Celexa and worsen the side effects or give you health risks.
• Tell your doctor if you are taking St. John’s wort or tryptophan.
• Inform your doctor if you have a family history of long QT syndrome. This is a rare heart problem that causes irregular heartbeat, fainting, or sudden death. Tell your doctor also if you have every used street drugs or have overused prescription medications.
• Inform your doctor if you:
  • Are 60 years or older
  • Have experienced slow or irregular heart beat
  • Have high blood pressure
  • Have experienced bleeding problems
  • Have experienced stroke
  • Have low levels of magnesium or potassium in your blood, had a heart attack, heart failure and other heart conditions
  • Have seizures
  • Have kidney or liver disease
  • Have experienced severe vomiting, diarrhea, or sweating, or if you have experienced this while taking Celexa.
  • Have personal or family history of suicide/ suicide attempts, bipolar/manic disorder
  • Have personal or family history of angle-closure glaucoma
• If you are pregnant or get pregnant while taking the drug, inform your doctor right away. The drug may cause problems in newborns following delivery if the drug is taken at the last trimester of the pregnancy. This medication may only be used by a pregnant woman when it is clearly needed as it may cause harm to the unborn fetus.
• Celexa may pass into breast milk and may have effects on the infant you are nursing. Ask your doctor for further instructions if you wish to continue this medication.
• Celexa may make you feel drowsy. Until you know how this medication may affect you, don’t operate machinery or drive a car after you’ve taken the drug.
• Alcohol may worsen the side effects of Celexa. Talk to your doctor about taking alcohol during your treatment.
• Celexa may cause angle-closure glaucoma. This happens when fluid is suddenly blocked and is unable to flow out of the eye causing a quick, severe increase in the eye pressure which may lead to loss of vision. Your doctor may recommend you to get an eye examination before taking this medication. If you experience nausea, eye pain, changes in vision, swelling or redness on your eye, get medical treatment and call your doctor right away.
• Before having any kind of surgery, inform your doctor or dentist that you are taking this medication, including all the other medications, supplements, and herbal products you may be taking.
• Older patients may feel more of the side effects of this medication including bleeding, loss of coordination, QT prolongation and salt imbalance (hyponatremia).
• Don’t stop taking this medication unless you are instructed by your doctor. It is dangerous if you stop this medication without informing your doctor. There have been reports of adverse events occurring upon discontinuation of these drugs, particularly when abrupt, including the following: dysphoric mood, irritability, agitation, dizziness, sensory disturbances, anxiety, confusion, headache, lethargy, emotional lability, insomnia, and hypomania.
• Celexa may cause abnormal bleeding. Concomitant use of aspirin, NSAIDs, warfarin, and other anticoagulants may add to the risk.

Long-Term Use Considerations

Most of the time, doctors prescribe Celexa for 6 months. But some instances lead a doctor to prescribe it for 9 months.

Some long-term considerations for most antidepressants is that it increases a patient’s risk for type 2 diabetes, abnormal heart rhythms, problems with blood clotting normally due to the decrease of serotonin in blood platelets, stomach bleeding, bleeding in the uterus, and lowered sexual interest or poorer performance both in men and women.

In rare cases, older patients who use the drug may experience a severe fall in sodium levels. This may lead to a dangerous condition where fluid builds up inside the body’s cell and cause the person to stop breathing and go into coma. There are also rare cases of elderly patients developing tics, muscle spasms, dyskinesia, parkinsonism, and akathisia.

Celexa may cause long-term psychological changes. After long usage, a patient may feel a condition when an SSRI drug suddenly diminishes its effectivity suddenly, causing a person to relapse in depression symptoms.

Additionally, some patients have reported having suicidal thoughts while taking Celexa. Those who were more susceptible to this condition were patients aged 25 and below. This may be due to another illness that has not yet been diagnosed such as bipolar disorder.

Drug Interactions

Drug interactions happen when a substance that you are taking changes or disrupts a drug’s intended function. Interactions may be harmful to you, increase your risk for serious side effects, or inhibit a drug from functioning properly. Always consult a doctor if you are going to start a medication with a new drug.

Can Interact with the Following

Severe drug interactions with Celexa (citalopram) include:

• Dronedarone
• Goserelin
• Isocarboxazid
• Leuprolide
• Phenelzine
• Pimozide
• Procarbazine
• Selegiline
• Selegiline transdermal
• Tranylcypromine
• Ziprasidone

Celexa has serious interactions with at least 79 other drugs and moderate interactions with at least 208 different drugs. Ask your doctor if you are taking or are planning to take other medications.

Can’t Interact with the Following

• Hypersensitivity
• Coadministration with pimozide
• Coadministration with serotonergic drugs
  • • Concomitant use or using within 14 days of MAOIs increases risk of Serotonin Syndrome
    • Using Celexa with a patient who has been treated with linezolid or IV methylene blue increases the risk of Serotonin Syndrome

When To Stop Taking

Stopping Celexa may only be done upon the advice of your doctor. Stopping this medication abruptly may cause adverse reactions and may harm you. Talk to your doctor if you need to stop because of:

• Allergic reactions to the drug
• Pregnancy
• Adverse reactions and side effects
• You feel like the drug has stopped working
• You feel like you don’t need the drug anymore

If you wish to stop for any other reason, talk to your doctor first. Don’t stop taking the drug or lessen or add to the dose by yourself.

Long-Term Side Effects

• Type 2 diabetes
• Weight changes
• Abnormal heart rhythms
• Problems with blood clotting normally
• Stomach bleeding or bleeding in the uterus
• Lowered sexual interest or poorer performance
• Development or increase in suicidal thoughts especially in patients aged 25 and below
• “Prozac poop-out”- a condition where an SSRI medication suddenly decreases its effectivity and endangers a patient to relapse into depression
• In older patients:
  • Severe fall in sodium levels (hyponatremia)
  • Development of tics and muscle spasms
  • Development of dyskinesia
  • Development of Parkinson’s disease
  • Occurence of akathisia due to anxiety

FDA Warnings (History Of)

As of 2019, the total of FDA’s warnings are as follows:

The US Food and Drug Administration is clarifying dosing and warning recommendations for the drug Celexa (citalopram hydrobromide). There is a possibility that high doses of the antidepressant can cause dangerous abnormalities in the electrical activity of the heart.

Additional information for patients:

• Do not stop taking Celexa or change your dose without talking to your healthcare professional. Stopping Celexa suddenly can cause withdrawal effects.
• If you are currently taking a Celexa dose greater than 40 mg per day, talk to your healthcare professional.
• Seek immediate care if you experience an irregular heartbeat, shortness of breath, dizziness, or fainting while taking Celexa.
• If you are taking Celexa, your healthcare professional may occasionally order an electrocardiogram (ECG, EKG) to monitor your heart rate and rhythm.
• Your healthcare professional may also order tests to check levels of potassium and magnesium in your blood.

Additional Information for Healthcare Professionals:

• Celexa causes dose-dependent QT interval prolongation, which can cause Torsades de Pointes, ventricular tachycardia, and sudden death.
• Celexa is not recommended for use at doses greater than 40 mg per day because such doses cause too large an effect on the QT interval and confer no additional benefit.
• Celexa is not recommended for use in patients with congenital long QT syndrome, bradycardia, hypokalemia, or hypomagnesemia, recent acute myocardial infarction, or uncompensated heart failure.  Celexa use is also not recommended in patients who are taking other drugs that prolong the QT interval.
• The maximum recommended dose of Celexa is 20 mg per day for patients with hepatic impairment, patients who are older than 60 years of age, patients who are CYP 2C19 poor metabolizers, or patients who are taking concomitant cimetidine (Tagamet®) or another CYP2C19 inhibitor, because these factors lead to increased blood levels of Celexa, increasing the risk of QT interval prolongation and Torsade de Pointes.
• Electrolyte and/or ECG monitoring is recommended in certain circumstances
  • Consider more frequent ECG monitoring in patients for whom Celexa use is not recommended, but is, nevertheless, considered essential.
  • Patients at risk for significant electrolyte disturbances should have baseline serum potassium and magnesium measurement, with periodic monitoring.  Hypokalemia and/or hypomagnesemia may increase the risk of QTc prolongation and arrhythmia and should be corrected prior to initiation of treatment with periodic monitoring.
• Celexa should be discontinued in patients found to have persistent QTc measurements greater than 500 ms.
• Advise patients on Celexa to contact a healthcare professional immediately if they experience signs and symptoms of an abnormal heart rate or rhythm (e.g., dizziness, palpitations, or syncope).  If patients experience symptoms, the prescriber should initiate further evaluation, including cardiac monitoring

In 2004, the FDA issued a change in most SSRI pregnancy categorization. This is due to research studies that have shown that SSRIs, including Celexa, may cause or increase the risk of birth defects. The birth defects may include:

• Septal/ Heart defects
• Persistent Pulmonary Hypertension of the Newborn (PPHN)
• Physical Birth Defects

Other Common Side Effects

Short term side effects include:

• Dry mouth
• Nausea
• Appetite loss
• Drowsiness
• Muscle or Joint pain
• Constipation
• Stomach pain
• Heartburn
• Frequent urination
• Changes in libido
• Yawning
• Sweating
• Excessive tiredness
• Weakness
• Uncontrollable shaking of a part of the body
• Heavy menstrual period

These side effects may be serious. Seek medical help immediately if you experience:

• Chest pain
• Shortness of breath
• Dizziness
• Fast, slow, or irregular heartbeat
• Hallucinating
• Fever
• Excessive sweating
• Confusion
• Coma (loss of consciousness)
• Loss of coordination
• Stiff or twitching muscles
• Hives or blisters
• Rash
• Itching
• Difficulty breathing or swallowing
• Swelling of the face, throat, tongue lips, eyes, hands, feet, ankles, or lower legs
• Hoarseness
• Unusual bleeding or bruising
• Headache
• Unsteadiness
• Problems with thinking, concentration, or memory
• Seizures
• Increased risk of suicide
• Changes in heart rate
• Serotonin Syndrome
• Allergic reaction

Celexa may cause children to have decreased appetite and weight loss. Talk to your child’s doctor for more information.

Lawsuits

Lawsuits are being filed against Forest Laboratories due to the medical injuries and birth defects patients and their families have experienced because of Celexa. The women who gave birth to babies with physical defects claim that they would not have taken Celexa if they were informed of the risk. At least two lawsuits that were filed included death; one involving a patient who committed suicide while on medication, another where an infant died after the mother took the prescription medicine while pregnant.

Forest Laboratories were also accused of falsely marketing the drug as safe for use in children. The company denied these allegations but in 2010, Forest Pharmaceuticals paid $13 million as settlement and pleaded guilty when the Department of Justice charged them with obstruction of justice after several employees lied to the FDA inspectors while an inspection inside the Forest facility was going on.

Tracy Everhart

Tracy Everhart is the Editor for Drug Law Journal. A highly-trained and certified medical professional, Tracy is also an accomplished medical writer. After spending years on the front lines of the medical profession, Tracy now devotes her expertise and skills to researching and reporting on new drugs and devices that enter the market, as well as their side-effects and the real-life stories involved. Prior to joining Drug Law Journal, Tracy wrote for benchmark online healthcare resources focused on families and, in particular, women’s health issues. Tracy holds post-graduate degrees from both the American College of Healthcare Sciences and the Yale School of Nursing. She is also a graduate of both Hampshire College, where she studied microbiology and the University of South Carolina school of nursing.