A Brief Guide to Filing a Cymbalta Lawsuit:
Cymbalta utilizes Duloxetine to treat generalized anxiety disorder and depression. The drug is also used to treat tingling and pain caused by diabetic neuropathy and fibromyalgia. Moreover, Cymbalta may be prescribed to treat ongoing muscle or bone pain, such as lower back pain. Cymbalta belongs to a class of medications known as norepinephrine reuptake and selective serotonin inhibitors. It is effective by increasing the amounts of orepinephrine and serotonin in the brain to promote mental balance.
Cymbalta Side Effects:
Although effective, Cymbalta carries significant risks. These risks; however, have not prompted significant litigation. The most prominent Cymbalta side effects concern the possibility of an increased suicide risk in children, young adults and teens. In 2005, the manufacturer updated its safety information to reflect these Cymbalta side effects.
• Nausea; constipation; dizziness; headache; weakness; drowsiness; muscle cramps or pain; uncontrollable shaking of the body; excessive fatigue; stomach pain; unusual breathing; swelling of the abdomen; loss of appetite and confusion.
Cymbalta FDA:
The bulk of Cymbalta lawsuits are filed because of the drug’s severe side effects, particularly suicidal thoughts and behaviors. These Cymbalta lawsuits were formed uniformly to other popular antidepressants. As early as 1990, users reported that antidepressants promoted suicidal thoughts and behaviors.
The United States Drug Administration, in response to these findings, di nothing. However, the link became increasingly obvious; antidepressants had a direct adverse effect on children and teenagers, making them violent, irrational or suicidal. These observations were solidified in 2006, when the FDA analyzed the results of 372 study cases of antidepressant users, finding that young adults were more inclined to severe changes in behavior while under the influence. This study prompted the FDA to enforce anti-depressant manufacturers to include warnings on all product labels.
As the adverse effects became more transparent, the FDA required more stringent prescription requirements and warnings. These warnings culminated with a “black box” warning for Cymbalta.
Cymbalta Lawsuits:
Only one significant Cymbalta lawsuit has been filed to date. The particular Cymbalta lawsuit, which is still pending, concerns a 16-year-old South Dakota boy who killed himself in 2004 after beginning Cymbalta treatment. The Cymbalta lawsuit says that the manufacturer (Eli Lilly and Company) failed to provide adequate warning of suicidal urges; the boy’s family in this Cymbalta lawsuit claimed that Eli Lilly and Company was directly responsible for the boy’s death. This Cymbalta lawsuit is seeking a settlement for the pain and suffering endured by the boy’s family.
While this is the most prominent Cymbalta lawsuit, there are others that are currently ongoing. That being said, the bulk of Cymbalta lawsuits are enacted and rendered in a private manner—the details and the subsequent settlements are rarely publicized.
In addition to concerns about Cymbalta withdrawal, concern has arisen about the drug's potential for creating birth defects. The FDA classifies the drug as a Category C medication for pregnant women--a warning that Cymbalta side effects may affect both the birth and health of the child. A 2006 study published in the New England Journal of Medicine concluded that use of this drug and similar antidepressants after the 20th week of pregnancy increases the risk of heart problems in an infant by up to six times.
Another study published in the American Journal of Obstetrics and Gynecology contributed more information regarding potential Cymbalta side effects. In this study, one-third of women taking antidepressants continuously throughout pregnancy, were found to have complicated or difficult pregnancies.
This evidence is more substantive than the reports concerning Cymbalta withdrawal. Because prescription information currently does not warn of these birth defect risks, women who experience such complications could file a Cymbalta lawsuit. However, as in cases of Cymbalta withdrawal, the lack of studies specifically concerning the drug could impede litigation.
Sources:
1. United States National Library of Medicine “Duloxetine” retrieved from:
http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0000274/
2. FDA News Release retrieved from:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm232708.html
3. FDA Duloxetine (marketed as Cymbalta) information retrieved from:
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm114966.html