August 24, 2011: The FDA Drug Safety Communication for Celexa has recommended that anyone taking the anti-depressant Celexa take no more than 40mg a day. The FDA states that higher doses may cause abnormal heart rhythms and that studies have shown there is no therapeutic benefit with doses higher than 40mg and includes generic versions of the drug.
The public has recently become aware that the antidepressant drug Celexa has been associated with serious birth defects problems. Celexa is a medication known as a selective serotonin reuptake inhibitors (SSRI) manufactured by Forest Laboratories. An article was recently published that stated that women of childbearing age that had taken antidepressant medications such as Celexa during pregnancy and subsequently had a child born with congenital birth defects.
SSRI Antidepressant Drugs
This class of SSRI antidepressant drugs, which include Paxil, Prozac and Zoloft each have different side effects for the unborn child associated with them including increased risk of premature birth, breathing problems, gastrointestinal side effects and other birth defects.
The degree of risk of Celexa birth defects is currently unknown, however the risk of developing complications has been reported in babies following use of these medications. Women taking Celexa or other antidepressant drugs during their pregnancy can expose their baby to the medication while in the womb leading to the development of a birth defect.
On December 13, 2006, the FDA announced antidepressants prescribed to young adults are risky. The agency proposed expanding the labels of all antidepressants to include an expanded warning of suicidal thoughts in patients ranging from 18-24 years of age. The newly presented change would expand a warning now on the labels that pertain only to children and adolescents treated with antidepressant drugs. The new label changes would also contain a suggestion that patients of all ages be carefully monitored, particularly when starting antidepressant treatment.
The FDA recently completed a bulk evaluation of 372 studies involving approximately 100,000 patients and 11 antidepressants, including Lexapro, Zoloft, Prozac and Paxil. When the results are analyzed by age, it becomes clear there is an elevated risk for suicidal thoughts and behavior among adults 18 to 25 that approaches that seen in children, the FDA said in documents released before their scheduled December 13, 2006 meeting of its psychopharmacologic drugs advisory committee.
Celexa not approved for Pediattric Depression, Prescribed Off-Label for Pediatric Depression
Celexa, manufactured by Forest Pharmaceuticals, hit the U.S. market on July 17, 1998. Celexa is a SSRIs (Selective Serotonin Reuptake Inhibitors) a newer and more commonly prescribed antidepressant. Because the Food Drug Administration (FDA)has not approved the use of Celexa for pediatric depression, Forest has been legally barred from promoting them for such uses. But doctors are allowed to prescribe drugs off-label where they see fit, and Celexa is the fourth most prescribed medication for pediatric depression.
On January 7, 2004, Forest Laboratories received a wide-ranging request from the New York Attorney General, Eliot Spitzer, asking for information about how the company tested and promoted drugs like its antidepressant Celexa for so-called off-label, or as yet unapproved, uses. Mr. Spitzer’s action follows an article in The New York Times which disclosed that Forest did not tell a medical journal about a failed, unpublicized trial of Celexa in children and adolescents when it published an article this month about a positive trial of the same drug in the same types of patients. Some of the article’s authors were Forest employees.
In addition to the aforementioned side effects associated with antidepressants, a new study has linked these drugs to an increased risk of death amongst patients with coronary artery disease. This study, which was conducted at Duke University, analyzed the survival rate of heart disease patients using antidepressants compared with those not using these drugs.
During an average of three years of follow-up, 21.4% of the patients taking antidepressants died compared with 12.5% of those not on antidepressants. After adjusting for demographic factors, cardiac risk factors, scores on the Beck Depression Inventory test, and the presence of other illness, antidepressant use was an independent risk factor for mortality, increasing the risk by 62%.
Researchers do not fully understand why antidepressants increase the risk of mortality in these patients. However their findings are statistically significant and show that these drugs do increase the risk of death in heart disease patients. Current and former heart disease patients should weigh the risks and benefits of antidepressants before using these medications.
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