Celexa is a type of antidepressant medication. It is placed in the same drug class as Zoloft and Paxil. The drug is known to have the potential to cause birth defects in newborn babies if mothers took the drug during pregnancy.
What Is Celexa?
Celexa, or citalopram hydrobromide, is a prescription medication that is a type of SSRI (selective serotonin reuptake inhibitor). It comes in various strengths and was originally approved by the FDA in 1998. The drug is manufacturerd by Forest Laboratories. The drug does not have approval for prescription to children. Some 7.2 million adults were prescribed the drug in 2011.
In 2010, the pharmaceutical giant, Forest Laboratories, had to pay out $313 million to settle in both criminal and civil complaints, which stated that it had marketed the product to children. These allegations were denied, but they did plead guilty to obstruction of justice under their settlement agreement, stating that lies had been submitted to the FDA when they inspected the Forest Laboratories plant.
Specific health warnings have been issued by the FDA in relation to Celexa recently. The warnings have to do with the potential to disrupt regular heart function, particularly in patients who take a higher dosage. Now, labels have to have a warning so that people with heart conditions are aware of this.
A number of studies have also linked SSRIs, including Celexa, to an increase in suicidal actions and thoughts. Additionally, there is a documented link to birth defects when taken in pregnancy. It is alleged that Forest Laboratories was aware of these risks, but didn’t warn consumers.
How Celexa Is Used
Celexa works by increasing levels of serotonin, a neurotransmitter that regulates mood, emotion and sleep. The FDA has approved the drug for treating major depression. However, physicians has been using it off label (without authorization) to treat:
Those people who use Celexa should see their mood improve after between four and six weeks of treatment. Remission is expected after a few months, however. This means the drug is not suitable as a long term treatment.
Celexa and Birth Defects
The FDA has categories for all types of drugs. These range from A to X (and an N side category for untested drugs), with A being the least harmful and X being the most harmful. Celexa is a class C drug, which means animal fetuses have been affected during tests, but there are no available tests for human fetuses. Most experts agree that the risk of developing birth defects from taking Celexa is low.
It is a known fact, however, that there is a slight increase in the chances of giving birth to a baby with birth defects if SSRIs are used in the first trimester. It is also believed that those women are more likely to have a baby with low birth weight or to experience premature delivery. If the drug is taken in late pregnancy, the baby could experience withdrawal symptoms, including feeding difficulties, seizures and behavioral problems, although these are usually short term issues. Because the risk is relatively small, doctors continue to prescribe SSRIs to pregnant women. They believe that not prescribing the medication could have more serious negative effects.
In 2009, the American Psychiatric Association and the American College of Obstetricians and Gynecologist joined up and stated that using SSRIs during the first trimester could lead to an increased chance of babies being born with a heart defect. The study found that this was particularly prevalent in women who took more than one SSRI.
Persistent Pulmonary Hypertension of the Newborn (PPHN)
There is also a link between using Celexa throughout the later months of pregnancy and birth defects. The New England Journal of Medicine published a study in 2005 that showed that Celexa in the third trimester could increase the chance of babies developing PPHN, a potentially deadly condition. The defect can cause long term health problems and is often fatal, as it stops the lungs from properly moving oxygen through the body. It was also in 2005 that the FDA first stated that all SSRI manufacturers had to include a PPHN warning on their labels.
Anencephaly, Craniosynostosis and Omphalocele
In 2007, the New England Journal of Medicine published a report in which it showed that SSRIs like Celexa were linked to a marginally higher risk of three specific birth defects. These are:
• Anencephaly, a type of cranial birth defect. Here, much of the brain and skull is missing, and most children die within a few minutes or hours.
• Craniosynostosis, a cranial birth defect whereby a child’s skull fuses too early. This can be repaired with surgery.
• Omphalocele, whereby some of the internal organs are outside of the baby’s body. Treatment may be available in certain cases, such as where a small part of the intestine protrudes. If more or larger parts of organs protrude, surgery will have to be offered in stages. Long term prognosis varies depending on the extent of the damage.
Celexa Side Effects
There are a number of serious side effects associated with the drug, which all require immediate medical intervention. One of the most serious is a heightened risk of suicide. However, changes in heart activity, allergic reactions and serotonin syndrome are also possible.
Worsening Depression and Suicide Risks
SSRIs are known to increase suicidal behaviors and thoughts. Some impulses may be violent, dangerous and/or aggressive. Many also suffer from panic attacks and anxiety. Young adults and teens are at particular risk. If these symptoms appear, patients should immediately seek medical attention. However, they should not stop taking their medication, as this could also lead to extreme reactions.
Changes in Heart Activity
People who take Celexa often experience shortness of breath, chest pain, fainting, dizziness, charges in heart rate and more. There was a 2011 warning that Celexa should not be prescribed at dosages over 40mg because of these dangers.
Serotonin syndrome has the potential to be lethal. It happens if too much serotonin is present in the brain, and it is most common in people who take more than one drug that affect serotonin. Symptoms, including hallucination, muscle twitches, fever, racing heartbeat, diarrhea, stiff muscles and more, have the potential to put someone in a coma, or it can even be fatal. Those who suspect they have serotonin syndrome must immediately go to the emergency room to be observed. They may be prescribed different drugs to combat the effects of serotonin syndrome, which is why it is vital to inform a medical professional if the patient is also pregnant.
Severe Allergic Reaction
All medication has the potential to cause an allergic reaction. Symptoms include facial swelling, difficulty breathing, itchy hives or welts, fevers, and joint pain. Those who are having an allergic reaction to a drug must immediately seek medical attention.
Common Side Effects
The above side effects are quite rare. However, Celexa and other SSRIs also have a number of common side effects. These include:
• Difficulty sleeping.
• Constant yawning and sleepiness.
• Anxious feelings, shaking, dizziness, weakness.
• Impotence or loss of sexual interest.
• Dry mouth.
• Diarrhea or constipation.
• Loss of appetite.
• Respiratory infections.
• Weight loss or weight gain.
Some of these symptoms will go away once the body adjusts to the medication. Others, however, stay for as long as patients take it.
Celexa Pregnancy Warnings
There have been a number of different studies that demonstrate embryofetal toxicity did occur in animal studies, including teratogenicity, which affects postnatal development. However, the doses, which were also maternally toxic, were higher than human therapeutic doses. No controlled data currently exists in relation to a human trial. In fact, there have been 2,500 exposed subjects, none of which noticed malformative feto or neonatal toxicity. A subsequent study involving 396 pregnant women demonstrated that Celexa was not associated with any major teratogenic risk.
However, there have been spontaneous abortions. Additionally, clinical findings have noticed that mothers who took Celexa during the third trimester had an increased chance of giving birth to a child with cyanosis, respiratory distress, seizures, apnea, feeding difficulties, temperature instability, hypoglycemia, vomiting, hypertonia, hypotonia, tremor, hyperreflexia, irritability, jitteriness and continuous crying. Usually, these effects are instantly noticeable and it is believed that they are linked to the toxic effect of the drug. Alternatively, it could be due to drug discontinuation. There have also been some cases where the symptoms were consistent with serotonin syndrome.
Some studies suggest that Celexa taken during late pregnancy can increase the chance of the child developing PPHN. Additionally, there could be an effect on sperm quality in boys, although this may be reversible. As it is a reasonably new finding, studies to prove the long term effects are not yet available.
As a result of these studies, the FDA has stated that Celexa should only be used during pregnancy if physician and patient agree that the benefits of taking the drug outweigh the risks of birth defects. Additionally, if a mother does take the drug, particularly during later stages of pregnancy, she and the baby should be offered additional monitoring during the third trimester. Finally, it is not recommended to suddenly stop the drug during pregnancy.
Celexa Breastfeeding Warnings
Women who want to breastfeed should not take Celexa. In fact, the official guidance is that they should choose between taking the drug or nursing. This is because it is excreted into human milk. If an infant does come into contact with it, the child should be monitored for drowsiness. On a side note, it is known that women who take SSRIs when they are pregnant often require extra breastfeeding support, because they find breastfeeding more difficult.
There have also been some reports of adverse side effects in babies breastfed by mothers who take Celexa. These include fussiness and drowsiness. However, there have not been any reports about adverse effects on the child’s development even after following up the children after a full year. Some physicians feel that mothers should continue to take Celexa while breatsfeeding if they also took it during pregnancy, although perhaps at a lower dosage. Again, this must be done in full consultation with the patient.
• FDA Drug Safety Communication: Abnormal heart rhythms associated with high doses of Celexa (citalopram hydrobromide)
• FDA Drug Safety Communication: Revised recommendations for Celexa (citalopram hydrobromide) related to a potential risk of abnormal heart rhythms with high doses
• Celexa label briefing by the FDA
• Celexa (citalopram hydrobromide) Tablets and Oral Solution
• Depression During Pregnancy: Treatment Recommendations
• Selective Serotonin-Reuptake Inhibitors and Risk of Persistent Pulmonary Hypertension of the Newborn
• Use of Selective Serotonin-Reuptake Inhibitors in Pregnancy and the Risk of Birth Defects
• First-Trimester Use of Selective Serotonin-Reuptake Inhibitors and the Risk of Birth Defects