Celexa (citalopram) is an SSRI-type prescription antidepressant medication approved to treat depression and has been used for other mental disorders such as anxiety. It may cause a number of severe or serious side effects, including birth defects and other conditions which may result in serious injury or death.
Multiple lawsuits have been filed against Celexa’s manufacturer, Forest Laboratories, by women and families whose children were born with birth defects, or whose loved ones became suicidal after using Celexa. Forest was accused of failure to adequately warn doctors and patients of the risks of Celexa including suicide and birth defects.
Forest settled 32 Celexa suicide lawsuits and was forced to issue refunds in a large class action lawsuit which claimed that users had purchased Celexa based on false claims. A number of other lawsuits were also dismissed.
Celexa Lawsuit Information
Celexa (citalopram) is a prescription antidepressant medication which is a member of the selective serotonin reuptake inhibitor (SSRI) class of medications. Serotonin is a neurotransmitter or chemical messenger which sends signals between nerve cells in the brain. SSRIs work by increasing activity serotonin in the brain’s mood centers.
Celexa was approved in 1998 to treat major depressive disorder in adults. Though it is not approved for other uses, it has been used off-label to treat conditions such as obsessive-compulsive disorder, anxiety, eating disorders and diabetic neuropathy. Celexa has been linked to a number of side effects including suicide risk and cardiac effects and may cause a number of birth defects, some of which are fatal.
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 failure 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.
Most of these lawsuits, filed in federal or state courts, including 32 suicide lawsuit, several hundred birth defect lawsuits and a class action lawsuit have been settled or resolved through dismissal.
Celexa Legal Difficulties
Celexa is only approved for use in adults with major depression in adults. The company is not allowed to promote the medication for any other uses, but Forest was accused of marketing the medication for use in children. The company denied the improper marketing accusation but in 2010, Forest paid $313 million to settle Department of Justice charges and pled guilty to a charge of obstruction of justice after several employees were found to have lied to FDA inspectors at a Forest facility.
In 2014, after a Dutch study showed that Celexa was no more effective than placebo in children. Forest agreed to a $4.7 million settlement for a class action suit involving Celexa use in children. Parents claimed that the company had misled parents about hate effectiveness of the medication. The company also paid $10.4 million in class action settlement refunds.
Celexa was approved in 1998 but the drug did not carry a suicide warning until 2004 when the FDA required that all SSRI antidepressants be given a “black box warning” regarding suicide risk. Celexa’s black box warning states that the medication may increase the risk of suicidal thoughts or behaviors and is particularly notable when medication is first started or during dosage changes. At least 32 lawsuits relating to suicide were filed against Forest after users attempted or were successful at suicide attempts.
Celexa Side Effects
Like all medications, Celexa may cause a number of side effects. Most of these side effects are mild and may subside after a period of time. Severe side effects however, may be serious, result in permanent injury or be life-threatening.
- Increased suicide risk – When Celexa is first started or a dosage change occurs, the medication may cause an increase in suicidal thoughts or behaviors. This risk appears to be worse in teens or young adults.
- Heart Effects – Celexa may cause changes in heart rate and conduction resulting in dizziness and fainting, chest pain, shortness of breath and may cause a potentially fatal heart rhythm known as Torsade de Pointes. The cardiac risk is worse when the drug is taken in high doses or with certain other medications or in people who have other cardiac conditions. In 2011, the FDA issued a warning against prescribing more than 40 mg per day of Celexa and recommended that doctors monitor heart activity with electrocardiograms (EKGs).
- Serotonin Syndrome – Serotonin syndrome is a potentially fatal adverse reaction cause by Celexa’s ability to increase the levels of serotonin in the brain. It may have symptoms such as increased heart rate and blood pressure, twitching or rigid muscles, hallucinations, agitation or coma and high fever.
- Allergic Reaction – Celexa may also cause a severe allergic reaction known as anaphylaxis which may cause the throat and airways to swell. Any difficulty breathing or swelling of the mouth, tongue, lips or throat should be treated as a medical emergency.
Celexa Birth Defects
Celexa has also been linked to a number of birth defects. In 2004, the pregnancy safety category of Celexa and most other SSRIs was changed from Category B to Category C, indicating a higher risk of fetal abnormality.
Use in early pregnancy may cause an increased risk of miscarriage or may later result in early-term birth or low birthweight. Late pregnancy use may result in Poor Neonatal Adaptation (PNA) due to “withdrawal” symptoms such as tremors, irritability, excessive crying, and feeding difficulty and may cause seizures in severe cases.
More severe birth defects that may be caused by Celexa include:
- 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.
- Persistent Pulmonary Hypertension of the Newborn (PPHN) – A potentially fatal condition which prevents the infant lungs from providing oxygen to the blood. This may deprive the body and brain tissues of oxygen, resulting in long-term disability or even death. A warning regarding PPHN was required to be added in 2006 but the FDA.
- Physical Defects – Physical birth defects may result from Celexa use including:
- Anencephaly – a missing portion of the brain and skull. Most often fatal within a short period of time.
- Craniosynostosis – the infant’s skull may begin to fuse too early. May be repairable with surgery.
- Omphalocele – abdominal organs may be present outside of the body at birth. Depending on severity, multiple surgeries may be required.
Celexa Lawsuit Claims
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 failure 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 risks but did not inform the medical community or the public, the plaintiff may be eligible for punitive damages.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.