Duloxetine hydrochloride, marketed as Cymbalta®, is a selective serotonin norepinephrine reuptake inhibitor (SSNRI but more commonly known as an SNRI) prescription antidepressant drug used to treat major depression. It is also used to treat anxiety, pain associated with diabetes, for the management of fibromyalgia, and for chronic muscle or bone pain.
Eli Lilly and Company, a major pharmaceutical and antidepressant drug manufacturer, manufacturers and markets Cymbalta. The U.S. Food and Drug Administration (FDA) first approved Cymbalta on August 3, 2004.
The FDA placed Cymbalta as a pregnancy “category C” drug. The FDA uses the category system to determine possible risks to a fetus when medicines are taken during pregnancy. When a drug is placed in category C, it means that the drug has not been studied in pregnant women, but has shown harmful side effects on fetuses in animal testing.
The first generic versions of Cymbalta (duloxetine delayed-release capsules), were approved by the FDA in December of 2013.
Pharmaceutical: Cymbalta
Manufacturer: Eli Lilly and Company
Generic name: Duloxetine (or duloxetine hydrochloride)
Drug Class: Selective norepinephrine reuptake inhibitor (SNRI) antidepressant
CAS Number: 59729-33-8
Guidelines:
Cymbalta, known generically as duloxetine, is in the class of antidepressant drugs known as serotonin and norepinephrine reuptake inhibitors (SNRIs). SNRI antidepressants are believed to function by increasing levels of the neurotransmitters serotonin and norepinephrine in the synaptic cleft. Cymbalta is used to treat
major depressive disorder (MDD) general anxiety disorder (GAD), diabetic peripheral neuropathic pain (DPNP), fibromyalgia (FM), osteoarthritis, and chronic musculoskeletal pain. It is available in 20 mg., 30 mg., and 60 mg. tablets.
Contraindications:
The use of Cymbalta with monoamine oxidase inhibitors (MAOIs) is contraindicated due to the risk of serious drug interactions that can be fatal (see section on Serious Adverse Outcomes below). Cymbalta is also contraindicated for patients with narrow-angle glaucoma.
Common Adverse Outcomes: [ From Physician’s Desk Reference 2013 ]
Serious Adverse Outcome:
The development of a potentially life-threatening serotonin syndrome or Neuroleptic Malignant Syndrome (NMS)-like reactions have been reported with SNRIs (including Cymbalta) and SSRIs alone, and when these drugs are used with medications that impair metabolism of serotonin (including MAOIs), or with antipsychotics or other dopamine antagonists. Serotonin syndrome symptoms may include:
Serotonin syndrome, in its most severe form, can resemble neuroleptic malignant syndrome, which includes high temperature, muscle rigidity, and autonomic instability (refers to the autonomic nervous system, which controls heart rate, breathing rate, body temperature, digestion, etc.), with possible rapid fluctuation of vital signs and mental status changes.
Warnings:
Discontinuing Cymbalta:
The Cymbalta label states: “Discontinuation symptoms have been systematically evaluated in patients taking duloxetine. Following abrupt or tapered discontinuation in placebo-controlled clinical trials, the following symptoms occurred at a rate greater than or equal to 1% and at a significantly higher rate in duloxetine-treated patients compared to those discontinuing from placebo: dizziness, headache, nausea, diarrhea, paresthesia [brain zaps], irritability, vomiting, insomnia, anxiety, hyperhidrosis [excessive sweating], and fatigue.”
The label also states: “Symptoms associated with discontinuation of Cymbalta and other SSRIs and SNRIs have been reported. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible [see Warnings and Precautions].” The Warnings and Precautions section states, “All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases.”
Medical Studies:
Pregnancy Category:
The FDA classifies Cymbalta as a Pregnancy Category C, which means there is no controlled data in human pregnancy studies but animal studies have shown an adverse effect on the fetus.
"Wisner Baum gave exceptional attention to all aspects of the case, detailed inquiry, and tenacious overview of all the information submitted. The paralegals are efficient and diligent. I was completely surprised to find an empathic personal message to take care of my own health during the challenging time of being a full-time caretaker.*"
In May of 2019, the jury in the case of Pilliod et al. v, Monsanto Company ordered the agrochemical giant to pay $2.055 billion in damages to the plaintiffs, Alva and Alberta Pilliod, a Bay Area couple in their 70s. R. Brent Wisner served as co-lead trial attorney for the Pilliods, delivering the opening and closing statements and cross-examining several of Monsanto’s experts. Wisner Baum managing shareholder, Michael Baum and attorney Pedram Esfandiary also served on the trial team in the Pilliod case.
The judge later reduced their award to $87M. Monsanto appealed the Pilliod’s verdict which the California Court of Appeal for the First Appellate District denied on August 9, 2021. Monsanto then requested the California Supreme Court review the appeal’s court decision, which the court denied on Nov. 17, 2021. Monsanto (Bayer) then submitted a petition for a writ of certiorari with the U.S. Supreme Court which SCOTUS denied on June 27, 2022, allowing the final judgment of $87M to remain intact.
$289.2 million jury verdict in Monsanto Roundup trial
Wisner Baum co-represented Dewayne “Lee” Johnson in the first Roundup cancer lawsuit to proceed to trial. On Aug. 10, 2018, a San Francisco jury ordered Monsanto to pay $39.25 million in compensatory damages and $250 million in punitive damages to Mr. Johnson, a former groundskeeper who alleged exposure to Monsanto’s herbicides caused him to develop terminal non-Hodgkin lymphoma.
Months after the jury verdict, the judge overseeing the trial reduced the punitive damages to $39.25 million. Mr. Johnson decided to accept the remittitur, bringing the adjusted amount awarded to Mr. Johnson $78.5 million.
Monsanto (Bayer) appealed the verdict and Johnson cross appealed. On July 20, 2020, the First Circuit Court of Appeals upheld the verdict against Monsanto but reduced Mr. Johnson’s award to $20.5 million. The company chose not to take the case to the U.S. Supreme Court, ending the litigation.
In 2016, Wisner Baum attorney Timothy A. Loranger and six other attorneys in the Plaintiffs’ Management Committee were able to secure a $265 million settlement for victims of the 2015 Amtrak 188 derailment in Philadelphia, one of the largest in the U.S. for 2016.
