Cymbalta Side Effects Lawsuit Attorney
Cymbalta Side Effects Attorney
Antidepressant Cymbalta ranks among the Top 10 most reported prescription drugs for adverse events in the United States. The drug was reported 278 times on the FDA MedWatch program for causing serious side effect injuries in 2011. According to the Institute for Safe Medication Practices, the nodal agency for monitoring prescription drug side effect injuries and the publisher of the QuarterWatch surveillance report, manufacturer Eli Lilly was aware of at least 789 incidents where users suffered from severe adverse events caused by Cymbalta.
Cymbalta carries a black box warning, the highest FDA safety alert, for suicidal thoughts and is listed as a “Do Not Use” pill by the consumer group Public Citizen. The antidepressant is used to treat major depressive disorders, musculoskeletal pain, diabetic peripheral neuropathy, and stress urinary incontinence. However, a number of research studies have also highlighted the fact that the antidepressant fails to offer any significant benefit over other existing medications commonly used to treat these disorders. The medication side effects are also linked to liver toxicity, psychiatric disorders, sensory disturbances, neurological problems, Stevens-Johnson syndrome, sexual dysfunction, and serotonin syndrome.
History of Cymbalta
Cymbalta Fact File
Generic Name: Duloxetine
Cymbalta Use: Major depressive disorders, fibromyalgia, musculoskeletal pain, chronic fatigue, diabetic peripheral neuropathy, stress urinary incontinence, and interstitial cystitis
Manufacturer: Eli Lilly, Indianapolis
Year of Approval: August 2004
MedWatch Complaints: 278 on MedWatch; 789 from manufacturers
Major Cymbalta Side Effects: Hepatoxicity, psychological side effects, withdrawal symptoms, Stevens-Johnson syndrome, orthostatic hypotension, sexual dysfunction, suicidal thought, serotonin syndrome
Cymbalta FDA Warning: 2005 FDA black box warning; October 2005 for liver injury; September 2007 for urinary problems; July 2011 for serotonin syndrome;
Cymbalta Drug History
- Duloxetine, the key ingredient in Cymbalta, was discovered in 1988 and Eli Lilly was granted the patent for it in 1990.
- Following clinical trials, the manufacturer filed for drug approval of the serotonin-norepinephrine reuptake inhibitor in 2001.
- In 2003, the FDA rejected the new drug application, citing violation of manufacturing practice standards and the possibility of potential liver toxicity caused by Cymbalta side effects.
- In August 2004, the FDA approved Cymbalta antidepressant to treat depressive disorders.
- In September 2004, the FDA permitted use of Cymbalta for diabetic neuropathy treatment.
- In February 2007, Cymbalta was allowed for the treatment of patients suffering from anxiety disorder.
- In November 2007, the FDA approved use of the drug for patients with major depressive disorders.
- In June 2008, the medication was permitted for the treatment of fibromyalgia, a type of rheumatoid disorders.
- In November 2010, the FDA approved Cymbalta for the treatment of chronic musculoskeletal pain.
Cymbalta contains Duloxetine, a serotonin-norepinephrine reuptake inhibitor that also blocks noradrenalin activity of the central nervous system. This, in turn, prevents creation of pro-inflammatory cytokines responsible for depressive disorders. The medication also inhibits sodium ion channels that help neutralize pain syndromes and diabetic neuropathy.
Cymbalta FDA Warnings
- In July 2005, the FDA asked manufacture Eli Lilly to add a black box warning to Cymbalta, cautioning users and doctors about the risk of suicidal behavior caused by Cymbalta side effects.
- In October 2005, the federal regulator warned about the risk of serious liver injury, hepatitis, and cholestatic jaundice, associated with Cymbalta. In October 2007, the label changes were made to include suicidal behavior by young adults following suicide by a 19-year-old who had joined Cymbalta clinical trial as a volunteer.
- In October 2007, the FDA admonished Eli Lilly for misleading Cymbalta promotional campaign cautioning the manufacturer against overstating the effectiveness of the drug.
- In September 2008, the safety labels were revised to include the possibility of urinary problems caused by Cymbalta side effects.
- In January 2010, manufacturer Eli Lilly was again warned by the FDA for issuing misrepresenting print advertisements making false claims about Cymbalta benefits.
- In July 2011, the FDA issued a public health alert informing about the risk serotonin syndrome and nervous system toxicity caused by Cymbalta side effects.
- In September 2011, Cymbalta label changes were effected cautioning against Stevens-Johnson Syndrome and other skin problems.
Cymbalta Side Effects Attorney
Psychological Side Effects
Cymbalta side effects lead to a two-fold increase in suicidal ideation and behavior. Patients treated with the drug are likely to experience manic and aggressive behavior, frequent mood change, nightmare, and restlessness.
Patients taking Cymbalta are at a risk of hepatoxicity, liver injury, and cholestatic jaundice. The drug can cause liver damage in patients already with preexisting liver injuries.
Withdrawal Side Effects Symptoms
Discontinuation of Cymbalta leads to spontaneous psychiatric and nervous system disorders akin to withdrawal symptoms. These symptoms, including seizures, emotional liability, anxiety, and paresthesias, can be severe in many cases.
In 2007, the FDA asked manufacturer Eli Lilly to examine the risk of skin problems, including Stevens-Johnson Syndrome, caused by Cymbalta side effects. Two years later, in September 2011, the label changes on the drug included the risk warning.
Cymbalta Sexual Dysfunction Side Effects
Sexual dysfunction causing decreased libido, problem in arousal and achieving orgasm, lack of sexual feeling, and ejaculation problems in patients treated with Cymbalta are observed during the Cymbalta therapy.
Cymbalta interaction with other drugs impact serotonin activity of the brain. It results in various cognitive, somatic, and autonomic disorders, such as motor abnormalities, muscle twitching, confusion, hallucinations, coma, hypertension, tachycardia, and cardiovascular changes. Aggravated serotonin syndrome ends up with nervous system toxicity and death.
Other Cymbalta Side Effects
- Gastrointestinal problems, such as gastric ulcer, dyspepsia, gingivitis, irritable bowel syndrome, and constipation
- Nervous system problems, such as CNS toxicity, memory problem, dyskinesia, seizures, failure to concentrate, insomnia, and confusion
- Dermatologic problems, such as Stevens-Johnson syndrome, hives, rashes, urticaria, and face edema.
- Cardiovascular problems, such as hypertension, peripheral edema, supraventricular arrhythmia
- Carcinomas in females
- Renal problems, such as urinary hesitation, infection, and micturition