What Is Celexa?
Celexa is the name brand for the generic medication citalopram hydrobromide and is a selective serotonin reuptake inhibitor (SSRI) prescription antidepressant medication used to treat depression. It is one of the most popular antidepressant medications in use and has also been used to treat other mental health conditions including bipolar disorder, obsessive-compulsive disorder, and anxiety disorders.
SSRI antidepressants, like 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 increases the level of serotonin in the brain.
Celexa is the brand name for citalopram hydrobromide and is manufactured by Forest Laboratories*. Celexa came onto the market in 1998. In its peak sales year, prior to patent expiration in 2003, 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. Even after generic approval and entry into the market in 2004, Celexa is still one of the top-selling antidepressant medications with an estimated over 21 million prescriptions issued in 2019.
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. However, it agreed to plead guilty to “obstruction of justice” as several Forest employees had lied to FDA representatives during a manufacturing plant inspection.
*Forest Laboratories became Allergan, and Allergan is now part of AbbVie.
Is Celexa FDA-Approved?
Celexa was approved to treat major depressive disorder in adults by the U.S. Food and Drug Administration (FDA) in 1998. Though it has been used to treat other mental health conditions, it has not been approved for those uses. Celexa is not approved for use in children. Some pediatricians may prescribe Celexa to children if the benefits offset the dangers of taking the medication.
The FDA has issued warnings about Celexa’s potential to cause a disruption in normal heart rhythm, particularly at high dosage levels. It requires that warnings about cardiac changes be included on all Celexa labeling. The FDA also warns that Celexa should not be taken in doses over 40 mg per day because of the effects it can have on the heart.
What Is Celexa Prescribed To Treat?
Celexa is only approved by the FDA to treat major depression. Symptoms of major depression include:
- 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
Celexa has also been prescribed “off-label” to treat other conditions. When a medication is prescribed off-label, that means that it does not have FDA approval to treat that condition. Federal law allows for medications to be prescribed for non-approved conditions, but pharmaceutical companies are prohibited from marketing medications to treat those non-approved conditions.
Conditions for which Celexa has been prescribed off-label include:
- Obsessive-compulsive disorder (OCD)
- Eating disorders
- Panic disorder
- Social anxiety
- Post-traumatic stress disorder (PTSD)
Some physicians have also used the medication for diabetic neuropathy, a degenerative nerve condition in diabetics that may cause extreme pain in some patients.
Is Celexa Safe To Take While Pregnant?
Celexa has been linked to an increased risk of birth defects and is classified as a Category C pregnancy medication. 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 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.
Until 2004, SSRIs were listed under pregnancy category B. However, 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.
The 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.
Celexa may cause “non-teratogenic effects” in newborns. These effects are not birth defects, but they may include complications that require lengthened hospital stays, respiratory support, and the use of a feeding tube after delivery.
Serious effects in newborns noted with Celexa may include:
- Respiratory distress
- Temperature instability
- Difficulty feeding
- Constant crying
- Vomiting s
Celexa use while pregnant may also increase the risk of some serious birth defects. Those include:
- Persistent Pulmonary Hypertension of the Newborn (PPHN) – Celexa use in late pregnancy is linked to the potentially fatal condition known as persistent pulmonary hypertension. This 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 the 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 skull 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.
- Septal defects – The wall between the heart chambers may not close properly, leaving a “hole” in the heart walls. This causes the heart to pump inefficiently and may cause heart failure or stroke and must be repaired through one or multiple surgeries.
Is It Safe To Take Celexa While Breastfeeding?
Because the medication is secreted in breast milk, mothers who are taking Celexa should exercise caution. Their infants should be monitored for possible adverse reactions.
These possible adverse reactions include:
- Extreme drowsiness
- Decreased feedings
- Weight loss
Most of the side effects of Celexa are mild and reversible, but others may require immediate medical attention.
Celexa may cause other common side effects such as:
- Loss of sexual interest
- Anorgasmia or impotence
- Dry mouth
- Changes in weight
Like all SSRIs, Celexa may cause serious side effects in some people.
Serious side effects may 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 changing doses of Celexa should watch for worsening mood or changes in behavior such as violent or aggressive behavior and excessive anxiety. Caregivers and loved ones of those taking Celexa should also watch for these changes. If changes are noted, a physician should be consulted but the medication should not be discontinued without medical advice.
- Heart Effects – When taken at high doses, Celexa may cause changes in heart rate, dizziness or fainting, chest pain, and shortness of breath. Because of this increased risk, the FDA issued a warning in 2011 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. It 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, nausea, and diarrhea. This condition warrants immediate medical treatment.
Multiple lawsuits have been filed by patients or their families against Forest Laboratories and its parent company, Allergan, due to medical injuries, birth defects, or suicide caused by Celexa. Lawsuits have accused the manufacturer of failing to adequately warn about the dangers of Celexa. Women who had taken Celexa during pregnancy and whose infants were born with birth defects have said that they would not have taken Celexa while pregnant if they had been told of the risk.
These lawsuits, filed in federal or state courts, include suicide lawsuits, several hundred birth defect lawsuits, and a class action lawsuit. Most have been settled or resolved through dismissal.
Drug manufacturers are responsible for ensuring that their medications are safe. They are also responsible for informing the medical community and the public about the risks of their medications. Forest Laboratories is being accused of failing to adequately warn doctors and patients of the risks of Celexa including suicide and birth defects.
Patients or their families who sue for medical injury may be eligible for reimbursement for damages including medical costs, lost wages, and pain and suffering. In some cases, if it can be shown that the manufacturer knew about the risks but did not inform the medical community or the public, the plaintiff may be eligible for punitive damages.
There are two main types of lawsuits that have been filed regarding potential claims patients and their loved ones may have against the manufacturer of Celexa.
These two lawsuit types are:
- Product liability
- Wrongful death
Both lawsuit types can result in monetary awards to the Plaintiff. They also help to raise awareness about dangerous products.
A medication manufacturer is charged with ensuring its medications are not unreasonably dangerous to patients and are safe for patients to take. Plaintiffs who have filed Celexa lawsuits allege that the manufacturer did not provide adequate warnings about the possible severe risks of taking Celexa. The plaintiffs argue that the injuries they or their loved ones sustained would not have resulted had they been properly warned about the risks associated with taking Celexa.
A wrongful death lawsuit can be brought by certain immediate family members of a deceased person against the individual or company that caused the loved one’s death. Those family members or close loved ones who may sue vary depending on state laws. Wrongful death lawsuits have been brought against the manufacturer of Celexa in situations where a baby died because of a birth defect linked to Celexa and in situations where it is alleged that Celexa led to suicide.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.