Celexa
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FROM: Psychiatric Times Forest Laboratories recently set aside $170 million in anticipation of eventually settling a federal government complaint about the company’s marketing and promotional practices.
In a press statement (http://www.frx.com/news/PressRelease.aspx?ID=1278589), Forest said that it provided a pretax reserve in the fourth quarter of fiscal year 2009 amounting to $0.45 per share, because of ongoing discussions with the US Department of Justice (DOJ) about its activities in connection with Lexapro (escitalopram), Celexa (citalopram), and Levothroid (levothyroxine).
The DOJ’s 34-page civil complaint charged that for more than half a decade, Forest illegally marketed citalopram and escitalopram for off-label use in pediatric patients, used “illegal” inducements to physicians to get them to prescribe the drugs, suppressed research, and caused false claims to be submitted to federal health care programs. (See Psychiatric Times, April 2009, or http://www.psychiatrictimes.com.) |
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Celexa (citalopram) is in a class of medicines called Selective Serotonin Reuptake Inhibitors (SSRIs). Celexa is used to treat depression.Celexa is made by Forest Laboratories, Inc., and was approved by the U.S. Food and Drug Administration (FDA) in 1998. Serotonin Syndrome In July 2006, the FDA issued an alert stating that a life-threatening condition called serotonin syndrome can occur when medicines called Selective Serotonin Reuptake Inhibitors (SSRIs, such as Celexa) and medicines used to treat migraine headaches known as 5-hydroxytryptamine receptor agonists (triptans), are taken together. Signs and symptoms of serotonin syndrome include: , hallucinations, loss of coordination, fast heartbeat, increased body temperature, fast changes in blood pressure, overactive reflexes, diarrhea, coma, nausea, vomiting Serotonin syndrome may be more likely to occur when starting or increasing the dose of an SSRI or a triptan. If you take migraine headache medicines, ask your healthcare professional if your medicine is a triptan. In July 2006, the FDA issued an alert announcing the results of a study looking at the use of antidepressant medicines during pregnancy by mothers of babies born with a serious condition called persistent pulmonary hypertension of the newborn (PPHN). Babies born with PPHN have abnormal blood flow through the heart and lungs, and do not get enough oxygen to their bodies. Babies born with PPHN can be very sick and may die. Results from the study also showed that babies born to mothers who took SSRIs 20 weeks or later into their pregnancies had a higher chance (were 6 times as likely) to have PPHN, when compared to babies born to mothers who did not take antidepressants during pregnancy. |
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Wapato, WA: Studies have shown that babies who are exposed to an SSRI prior to birth are at an increased risk of birth defects including congenital heart defects. Usually, there are certain heart problems that go along with SSRI exposure. However, what about the child who is one of a kind, who has a heart defect that has not been seen before?
 "I took Celexa for the first 10 weeks of my pregnancy," Shealynn says. "I had taken it before I knew I was pregnant and I took it for a while after I found out I was pregnant. I was told that there wasn't a risk with Celexa.
"I had a normal pregnancy. Dalton was born about 4 weeks early. We didn't know anything was wrong until birth, but once he was born we knew immediately that there were problems. He had a heart murmur that the doctors described as being like a washing machine. It was extremely loud, so they knew right away that something was going on. Also, his color was not good.
"We saw a cardiologist the day after Dalton was born. The cardiologist and the tech argued about they saw on his echocardiogram, which was done when he was one day old. It turns out, Dalton is one of a kind. He has a non-functioning partial valve off the aorta. The tech saw this on the echocardiogram, but the doctors didn't confirm it until Dalton was 11 months old, when he had his first surgery. He is the only child in history that has a third valve."
"Dalton was in congestive heart failure for the first 11 months of his life. They didn't do surgery immediately, but they watched him closely. We saw the doctor once a week for almost the first year of Dalton's life."
Shealynn says Dalton has been diagnosed with a long list of heart problems. "He has an unusual double outlet right ventricular with accessory aortic valve. He has undergone operative repair of his various defects, which included relief of aortic stenosis, patch augmentation of the pulmonic valve stenosis and closure of the ventricular septal defect. He also had oversewing of an accessory aortic valve. There is a grade 3 harsh systolic ejection-type murmur at the right upper sternal border and there is a grade 2 long diastolic murmur heard along the left sternal border."
After doctors performed Dalton's first surgery, they thought everything was fine. However, Dalton had a blockage above and below his valve, so surgery was required in June 2007, [just prior to his fourth birthday] to take the valve out. Dalton requires at least 2 and possibly 3 more surgeries on his heart.
The good news for Dalton is that he has so far, aside from his heart complications, been able to live a fairly normal life. Shealynn says that developmentally, he is right where he should be. Although he was a little delayed before his first surgery, following that surgery he progressed well and has caught up with his peers. He also has no restrictions—doctors want Dalton to live as normal a life as possible, especially so that his parents can learn to recognize when something is not right with Dalton. To that end, Dalton is a fairly active child.
Shealynn says she asked a cardiologist if Celexa could have caused Dalton's heart problems after she saw something about it on television. "He said, 'It could be Celexa.' I have six kids and he's the only one with any kinds of problems, and we don't have a history of these problems."
Doctors are currently hoping that his most recent surgery can hold him off from further surgeries until he is an adolescent. If that happens, then chances are he will only need 2 further surgeries. However, if his next surgery is required before Dalton hits adolescence, he will likely undergo at least 3 more surgeries. That's a lot of heart surgeries for anyone to go through, let alone a child. |
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Quick Facts
Manufacturer
Forest Laboratories Inc.
Status
On the market
Intended Uses
Depression
Complications
Serotonin syndrome, major birth defects, persistent pulmonary hypertension of the newborn (PPHN)
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