Celexa is the brand name for citalopram hydrobromide, a prescription antidepressant. It is manufactured by Forest Laboratories and in its peak sales year, prior to patent expiration, Celexa brought over $1.1 billion in revenue to Forest. At that time, Celexa sales were responsible for nearly half of Forest’s annual revenue. Celexa is still one of the top selling antidepressant medications with an estimated 7 million prescriptions issued each year.
Celexa is one member of the selective serotonin reuptake inhibitors (SSRIs) class of antidepressants. It was approved to treat major depressive disorder in adults by the Food and Drug Administration (FDA) in 1998 and has not been approved for use in children.
Studies have linked Celexa and other members of the SSRI antidepressant category to an increased risk of suicidal thoughts and actions. The medications have also been linked to a number of birth defects which may occur when taken during pregnancy.
In addition to the risk of suicide and pregnancy risks, the FDA has recently issued warnings about Celexa’s potential to cause a disruption in normal heart rhythm, particularly at high dosage levels. The FDA has required that warnings about cardiac changes be included on all Celexa labeling.
This is not the first sign of trouble for Forest. In 2010, the company was forced to pay $313 million to settle criminal allegations and civil complaints charging that the company had illegally marketed the medication to children. Forest denied the allegations made by the Department of Justice regarding improper marketing but agreed to plead guilty to “obstruction of justice” as several Forest employees had lied to FDA representatives during a manufacturing plant inspection.
Multiple lawsuits have been filed regarding harm caused by Celexa with claims that Forest Laboratories, the manufacturer knew about the risks and did not adequately warn the medical community or thee pubic.
SSRI antidepressants, including Celexa, work by increasing the activity of a chemical messenger in the mood centers of the brain. This chemical messenger is the neurotransmitter, serotonin which acts to regulate sleep and mood and may help provide the satiety or “satisfaction” sensation.
Celexa was approved by the FDA in 1998 and was intended to be an improvement on older SSRIs such as Paxil, Prozac and Zoloft. It is approved for the treatment of major depressive disorder but is also used off-label to treat anxiety and related disorders such as obsessive compulsive disorder and eating disorders. Some physicians have also used the medication for diabetic neuropathy, a degenerative nerve condition in diabetics which may cause extreme pain in some patients.
Celexa has helped many people recover from depression and other disorders but it has caused a number of serious adverse events which have resulted in medical injury.
Celexa is only approved to treat major depression which has symptoms such as:
- Loss of interest in normal activities
- Feelings of guilt or worthlessness
- Excessive crying
- Lack of energy
- Loss of concentration
- Changes in appetite
- Changes in sleep patterns
- Suicidal thoughts and tendencies
Patients who begin taking antidepressants usually do not notice significant changes in their mood state for several weeks but can see a remission of symptoms after a few months. Success in patients who are given the medication for off-label or conditions which have not been approved by the FDA may have different experiences in terms of time to effectiveness.
Celexa Birth Defects
The birth defect risk is defined by the FDA based on previous research and medical knowledge. Prescription medications are listed as one of five of these categories, A through D and pregnancy category X.
- Category A medications have been tested in pregnant women and animals and have shown no adverse effects.
- Category B medications have not shown any risk to a developing fetus in animal studies but there are no adequate studies done in humans.
- Category C medications have shown fetal risk in animals but there are no adequate studies in humans and the potential benefits of the medication may outweigh any potential risks.
- Category D medications have shown fetal injury in both animals and humans but the potential benefits may still outweigh a significant risk.
- Category X medications are known to be highly teratogenic or will cause fetal harm. This risk may have been demonstrated through studies or in adverse event reports. These risks clearly outweigh any potential benefits and should not be used in pregnant women.
Until 2004, SSRIs were listed under pregnancy category B but the FDA required a change in the labeling to list certain SSRIs as Category C due to adverse event reports. Several studies and statistical analyses have shown an increased birth defect risk when SSRIs are used during pregnancy.
Use of SSRIs during the first trimester of pregnancy is linked to an increased risk of miscarriage. Some studies have also suggested that these women may also be at risk of preterm birth or low-weight birth. Use of the medications in late pregnancy can lead to withdrawal symptoms in the infant such as tremors, high startle reflex, excessive crying, feeding difficulty and even seizures.
Other more serious birth defects have also been noted including:
- Heart defects – SSRI use in the first trimester has been linked to an increased risk of septal heart defects in infants. Septal defects cause a “hole” in the heart which may lead to heart failure or stoke and must often be repaired through surgery or multiple surgeries.
- Persistent Pulmonary Hypertension of the Newborn (PPHN) – Celexa use in late pregnancy is lined to the potentially fatal condition known as persistent pulmonary hypertension which prevents the infant’s lungs from circulating oxygen to the body and brain. It may be fatal or result in long-term health issues. In 2006, the FDA required a warning to be added to prescribing information for Celexa and SSRIs.
- Physical Abnormalities – SSRIs, including Celexa have been associated with an increased risk of three severe physical birth defects, anencephaly, craniosynostosis and omphalocele. Anencephaly is when a major portion of the brain and skill are missing. It is usually fatal within a short period after birth. Craniosynostosis causes a child’s skull to fuse earlier than normal but may be repairable through surgery. Omphalocele occurs when abdominal organs are present outside of the body at birth. Treatment depends on the severity and may involve multiple surgeries and permanent injury.
Other Side Effects of Celexa
Most of the side effects of Celexa are mild and reversible but others may require immediate medical attention.
Serious side effects include:
- Increased Suicide Risk – Celexa and other SSRIs may increase the risk of suicidal thoughts and behaviors. The risk is particularly high in teenagers and young adults. People who begin taking or change doses of Celexa and their caregivers should watch for worsening mood or changes in behavior such as violent or aggressive behavior and excessive anxiety. If changes are noted, a physician should be consulted but the medication should not be discontinued without medical advice.
- Heart Effects – Celexa may cause changes in heart rate, dizziness or fainting, chest pain and shortness of breath, particularly when taken at high doses. Because of this increased risk, in 2011 the FDA issued a warning stating that Celexa should not be used at doses over 40 mg per day and that electrocardiograms (EKG) should be used to monitor heart function.
- Serotonin Syndrome – Serotonin syndrome occurs because of an excess of serotonin in the brain and is potentially fatal. Symptoms include changes in mental function such as hallucinations or agitation, changes in mental status including coma, changes in blood pressure, increased heart rate, twitching or stiffness of muscles, fever, or nausea and diarrhea. This condition warrants immediate medical treatment.
Celexa may cause other common side effects such as nausea, loss of sexual interest, anorgasmia or impotence, insomnia, anxiety, weakness, dizziness, tremor, dry mouth, weight gain or loss, and constipation or diarrhea.
Multiple lawsuits have been filed against Forest Laboratories after Celexa was used during pregnancy and may have caused birth defects. Women have said that they would not have used Celexa during pregnancy if they had been warned of the risk. Others may be suing Forest for medical injuries caused to adults by the use of Celexa. No cases have yet been scheduled for trial.