Multiple lawsuits have been filed by patients or their families against Forest Laboratories due to medical injuries or birth defects caused by Celexa and 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. At least two of the lawsuits filed so far included death. One involving a patient taking Celexa who committed suicide and one involving the death of an infant after the mother took the medication during pregnancy.
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.
Celexa Legal Difficulties
Celexa is only approved for use in adults with major depression and 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 Pharmaceuticals, the subsidiary of Forest Laboratories 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.
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. Mild to moderate side effects of Celexa include:
- Loss of sexual interest or impotence
- Anxiety and Insomnia
- Weakness and Dizziness
- Dry mouth
- Weight gain or loss
- Constipation or diarrhea
Celexa may also cause a number of severe side effects, some of which may be life-threatening including:
- 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 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.
More About Celexa
Celexa is the brand name of the generic medication, citalopram hydrobromide. It is a prescription antidepressant medication which is a member of the 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 to treat conditions such as obsessive compulsive disorder, anxiety, eating disorders and diabetic neuropathy. Physicians are allowed to prescribe medications for “off-label” uses but the company is prohibited from marketing the medication for uses that have not been approved by the FDA.
Celexa is manufactured by Forest Laboratories and over 7 million prescriptions are written in the U.S. for the medication each year. Before the patent protection for Celexa expired, sales of the medication were estimated at $1.1 billion per year.
Celexa has helped many patients recover from depression but it has also 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 against Forest Laboratories for injuries and birth defects caused by Celexa.