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Injured by Lexapro?
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. In the United States, use of antidepressants for patients under 18 years has not been approved by FDA, with the exception of Prozac. This means that both the healthcare professional who prescribes or dispenses these drugs for children and adolescents and the pharmaceutical company that promotes this "off-label" (unapproved) use knowingly take a risk with the patient's safety. Antidepressants are widely suspected of contributing to suicidal and/or violent behaviors, especially in children. This point of view has recently been adopted by the U.S. Food and Drug Administration (FDA), somewhat more slowly than its British counterpart, the Medicines Control Agency.
Newer anti-depressants such as Lexapro, known as selective serotonin reuptake inhibitors (SSRIs), have come under recent scrutiny. Lexapro is prescribed to treat major depression. In March, the Food and Drug Administration asked the makers of SSRIs to include warnings that children and adults might become more depressed or suicidal while taking these drugs, and that close supervision, particularly at the start of treatment, is required.
Forest Pharmaceutical, the manufacturer of Lexapro, continues to downplay the drug's dangers.
Lexapro side effects include: Insomnia, Diarrhea, Dry Mouth, Somnolence (sleepiness or drowsiness), Dizziness, Increased Sweating, Constipation, Fatigue, Indigestion, Ejaculation Disorder (male), Decreased Libido (decreased sex drive) (both male and female), Impotence (male), Influenza-Like Symptoms (flu-like symptoms), Appetite Decreased, Rhinitis (runny nose), Sinusitis (inflammation of the sinuses), Possible Impairment of Fertility (inability to get pregnant), Danger of Birth Defects (Pregnant Females), Passing of Drug to Nursing Babies, Danger to Patients With History of Mania, Danger to Patients with History of Seizures, Danger to Patients with Suicidal Tendencies (note: Drugs such as Lexapro have been present in numerous suicide cases, although drug companies have denied the drugs as causes). Additional side effects include: Interference with operation of machinery including automobiles, Impairment of Judgment, Priapism (males) (Persistent, usually painful erection of the penis, especially as a consequence of disease and not related to sexual arousal).
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.
If you or a loved one took Lexapro and suffered side effects, please fill out the form at the right for a free case evaluation by a qualified drug side effects attorney.
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FDA Again Warns About Suicidal Thoughts and Behavior Among Young Adults on Antidepressants
May 3, 2007 | NewsInferno.com
The U.S. Food and Drug Administration (FDA) today issued new warnings about suicidal thoughts and behavior related to young adults taking antidepressants, and they have asked drug makers to update their label warnings appropriately. The FDA uses the term “suicidality” to describe what they call suicidal thinking and behavior. The new “black-box” label warnings, the most strident type of warning, would reflect the increased risks of suicidality in young adults, ages 18...
FDA Proposes New Warnings About Suicidal Thinking, Behavior in Young Adults Who Take Antidepressant Medications
May 2, 2007 | www.fda.gov
The U.S. Food and Drug Administration (FDA) today proposed that makers of all antidepressant medications update the existing black box warning on their products' labeling to include warnings about increased risks of suicidal thinking and behavior, known as suicidality, in young adults ages 18 to 24 during initial treatment (generally the first one to two months). The proposed labeling changes also include language stating that scientific data did not show this increased risk in adults older...
FDA plans to expand antidepressant warning
Dec 14, 2006 | Los Angeles Times
A Food and Drug Administration federal panel Wednesday recommended the agency issue its strongest possible warning to alert patients and doctors that antidepressants can increase the risk of suicidal thoughts and behavior in young adults. The panel called for placing the so-called black-box warning on product labels and in medication guides distributed to patients. Following the vote, FDA officials said they intended to expand the warning to include young adults. Since 2004, antidepressants...
Study shows pills raise suicide risk in young adults
Dec 14, 2006 | Washington Post
Widely used antidepressants double the risk of suicidal behavior in young adults, from around three cases per thousand to seven cases per thousand, according to a federal analysis of hundreds of clinical trials. It marks the first time regulators have acknowledged that the drugs can trigger suicidal behavior among patients older than 18. Officials at the Food and Drug Administration said Wednesday that the higher risk was found in patients between 18 and 25 and that the risk...
FDA may expand antidepressant warning
Dec 13, 2006 | AP
Treatment with antidepressants increases the risk of suicidal thoughts and behavior in patients age 24 and younger, according to proposed changes to the drugs' labels unveiled Wednesday by federal health officials. The proposed changes would expand a warning now on the labels that applies only to children and adolescents treated with the drugs. The Food and Drug Administration put forth its plan to update the drug labels early Wednesday at the start of a meeting of outside advisers convened...
Lexapro
Lexapro FDA Information
FDA Drug Information Facts
LEXAPRO (Vardenafil) FDA INFORMATION
The FDA issued several warnings concerning Levitra related side effects. The links below will redirect you to these warnings on the FDA website.
Quick Facts
Lexapro Reference Guide
Generic Name
Escitalopram oxalate
Date Approved
August 15, 2002
Manufacturer
Forest Pharmaceutical
Status
On the market
Approved Uses
Depression
Anxiety disorder
Serious Side Effects
Suicidal tendencies
Birth defects
Insomnia
Dizziness
Persistent pulmonary hypertension
Escitalopram oxalate
Date Approved
August 15, 2002
Manufacturer
Forest Pharmaceutical
Status
On the market
Approved Uses
Depression
Anxiety disorder
Serious Side Effects
Suicidal tendencies
Birth defects
Insomnia
Dizziness
Persistent pulmonary hypertension
Related Topics
Celexa
Cymbalta
Effexor
Luvox
Paxil
Prozac
Remeron
Wellbutrin
Zoloft
Defective Drugs
Diseases
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