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.
In May 2006, GlaxoSmithKline and the FDA cautioned Paxil may raise the risk of suicidal behavior in young adults too and changed the drug’s label to reflect that risk.
Increased Risk Of Suicidal Behavior Amongst Children
Federal health advisers overwhelmingly agreed that there is evidence linking antidepressants to an increased risk of suicidal behavior among some children taking the drugs. The 25-1 vote by two Food and Drug Administration panels came after members were told that a new warning added in March to antidepressants appeared to have little impact on children’s use of the drugs. Two-thirds of antidepressant prescriptions were written by psychiatrists. Ten to 20 percent were written by pediatricians. Dr. Michael Fant, a panel member, said, The off-label use of these medications is fairly promiscuous. And the prescribers extend well beyond those who are trained in the care of the mentally ill.
Independent experts and FDA scientists have said there is a definite link between antidepressants and the worsening suicidal fixations of children taking the drugs. Experts from Columbia University found that on average, antidepressants taken by kids will cause an extra 2 percent to 3 percent to have increased suicidal thoughts. Relative risks of suicidal behavior were highest among youths taking Luvox, Effexor and Paxil.
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, 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.
Legal Help For Victims Affected By Luvox
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