Cymbalta Side Effects Include: Suicidal Thoughts, Liver Disease, Birth Defects, Cleft Palate, Heart Valve Damage, SSRI – Personal Injury Lawyers
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.
Cymbalta Side Effects
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 drugs label to reflect that risk.
On October 17, 2005, Eli Lilly expanded its warning about potential liver-related problems with its depression drug, Cymbalta, and cautioned doctors against prescribing it to patients with chronic liver disease, U.S. health regulators announced. The new label for the drug also contains reports of hepatitis, jaundice and other liver-related problems in patients using Cymbalta.
The FDA has recently issued a new warning about the potential for suicidal thinking in adults taking antidepressants, but the agency specifically singled out Cymbalta (generic: duloxetine) because of a higher than expected rate of suicide attempts in recent studies. Cymbalta is a relatively new antidepressant manufactured by Eli Lilly that has been associated with suicide risk since its clinical trials.
The warning comes after a review of Cymbalta by Eli Lilly; found that 11 of nearly 9,000 women taking it for urinary incontinence tried to commit suicide. The fact that these patients were suffering from urinary incontinence and not depression is significant because the drug companies have long argued that antidepressants are used by depressed people who have a higher likelihood of committing suicide.
Cymbalta has been associated with suicidal behavior since Traci Johnson, a healthy volunteer involved in a trial at Eli Lilly’s clinic at Indiana University Medical Center in Indianapolis, killed herself in one of the clinics showers. Johnson, who did not suffer from depression, was taken off the drug and given a placebo four days before she hung herself in one of the clinic’s showers on February 7, 2004. Johnson was the fifth patient to commit suicide after taking Cymbalta in clinical trials. After her death one-fifth of the volunteers have quit the Cymbalta trial.
The FDA approved Cymbalta for use as an antidepressant last August 2004 but it is not approved in the United States to treat urinary incontinence. Cymbalta is an important drug for Eli Lilly, as some analysts believe its annual revenues can reach $3 billion by 2009. Cymbalta recorded $94 million in revenues in five months that it was on the market last year and $107 million the first three months of this year. The most recent FDA warning about the risk of suicide associated with antidepressants was different in that it specifically focused on the risk to adults.
Much of the concern over suicide and antidepressants has centered on children who use the drugs. The FDA last fall determined there is a real, but small, increase in risk of suicidal behavior for children and ordered the labels of all antidepressants to say so. The FDA issued a warning that adults, too, may be at increased risk. The agency began reanalyzing hundreds of studies of the drugs to try to determine if that’s the case, and told makers to add or strengthen suicide-related warnings on their labels in the meantime. Since then, several new studies have been published in medical journals about a possible connection.
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.
Consolidation of 28 Cymbalta Lawsuits Requested
Individuals who brought 28 lawsuits, nationwide, over Cymbalta, just requested that the U.S. Judicial Panel on Multidistrict Litigation (JPML) centralize the 28 actions in California. All of the lawsuits similarly allege that Eli Lilly & Co. misled patients about the adverse withdrawal reactions associated with Cymbalta withdrawal.
The individuals who brought the actions allege that Cymbalta led to withdrawal reactions and injuries when they either attempted to stop, or stopped, taking the drug and that Eli Lilly did not provide adequate warnings about these risks. Allegations also include that Eli Lilly touted the drug as having a significantly reduced risk of withdrawal symptoms; however, according to the JPML filing, although Eli Lilly indicated that the risk of adverse withdrawal reactions is 1 percent, the risk may actually be as high as 44.83-50.8 percent.
The 28 product liability lawsuits have been filed in various states nationwide, including Maryland, Georgia, Louisiana, Florida and Pennsylvania. Ten were filed in California and seven of the 10 were filed in the Central District of California, which is the district in which the plaintiffs seek consolidation. The 28 related actions are currently pending before 20 separate federal courts. The request to the JPML concerns these 28 actions, and any subsequently filed related actions, to a single judge for coordinated pretrial proceedings.
Withdrawal symptoms, according to the FDA’s “Medication Guide” on Cymbalta may include:
- Electric shock sensations in the body and brain (brain zaps)
- Excessive sweating
- Feeling tired
- Problems Sleeping
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