Health problems not on the box's label
Cymbalta has been embroiled in controversy for years. That is most likely because of withdrawal symptoms, collectively labeled as Cymbalta Discontinuation Syndrome. That sounds ominous, doesn't it?
Who uses Cymbalta?
Cymbalta, also known by its generic version of duloxetine, is intended to treat major depressive disorder and general anxiety disorder. It is in a class of medications called SSNRIs (selective serotonin and norepinephrine reuptake inhibitors). These affect brain chemicals in ways meant to control depression and anxiety, though sometimes they themselves cause the very problems they're supposed to be treating.
How does Cymbalta work?
Put simply, Cymbalta is believed to block the reuptake of serotonin and norepinephrine within the central nervous system (CNS). When the number of pro-inflammatory cytokines increases, depressive tendencies are thought to worsen. Duloxetine allegedly reduces pro-inflammatory cytokines while raising anti-inflammatory cytokines. (We say "allegedly" because there are no scientific studies to confirm this.)
It does, however, treat pain because of its analgesic qualities. That treats conditions like fibromyalgia and chronic pain.
Duloxetine was created by Eli Lilly researchers in 1986 and patented in 1990. Eli Lilly attempted to present it to the Food and Drug Administration in 2001, though the FDA stated the product was unapprovable in its current state because of manufacturing and control standpoint violations in their Indianapolis facility. They also noted concerns about potential drug-caused liver damage (hepatotoxicity). Eli Lilly fixed the problems at the Indianapolis outpost, and with a liver damage warning printed on the prescription information, the drug was approved by the FDA in 2004.
Duloxetine was approved for the use of stress urinary incontinence – but only in the United Kingdom. Eli Lilly decided not to pursue this effort in the United States because the FDA would not grant approval based on what was submitted (despite the fact it was approved for this use in 38 foreign markets).
Duloxetine side effects
There is a long list of side effects on Cymbalta's label. Many of them were not known about when the drug was first prescribed, and only after patients' complained louder and louder did authorities investigate.
- Dry mouth
- Heavy sweating
- Muscle cramps
- Less or no appetite
- Trouble urinating
- Sexual dysfunction
The most unexpected and unwanted side effect, however, came from the cessation of the drug. When patients tried to end their regimens, they found themselves unable to do so, facing concerning withdrawal symptoms.
Cymbalta Discontinuation Syndrome
No medication label talked about the electric-like shocks patients experienced when they tried to stop taking duloxetine. They even have a name: "brain zaps." These painful sensations are followed by confusion, dizziness and agitation.
It is recommended that patients stop taking duloxetine over a gradual period rather than an abrupt cessation. Cymbalta withdrawal symptoms and side effects from weaning too quickly are:
- Peripheral neuropathy in the hands and feet
Patients claim that these adverse effects were not made clear prior to beginning duloxetine regimens.
Some people even need to be hospitalized because of discontinuation syndrome. It was not until 2009 that the Food and Drug Administration conceded the fact that Cymbalta's label was insufficient compared to its risks. It also carries the black box warning because of the suicide risk.
Existing litigation for Cymbalta
Patients were certified as a class-action lawsuit in 2012. They claimed that Eli Lilly had misrepresented Cymbalta, and consumers from Missouri, Massachusetts, California and New York petitioned to be certified as a class in 2013. (Before allowing a class-action suit to proceed, the various plaintiffs must be certified by the court.) However, in 2017, after several legal struggles and false starts, the appellate court dismissed the plaintiffs' claim.
The one multidistrict litigation (MDL) for Cymbalta litigation was denied by the federal district court in 2014 when 28 individual cases attempted to consolidate. Another attempt was made with 40 cases in 2015. As of 2018, Eli Lilly is in settlement talks with 140 pending Cymbalta lawsuits. So far, the manufacturer has won four individual plaintiffs.
Most notable was how the company reported only 1% of users experiencing discontinuation symptoms, while plaintiffs claim that number is between 44% to 50%.
According to the National Pain Report,
As early as 2005, research indicated a high rate of what medical professionals call "adverse events" when patients stopped taking Cymbalta. This Lilly study found that 44 percent of patients involved in several short-term trials had "adverse events" when they suddenly stopped taking duloxetine (the generic name for Cymbalta). The most common withdrawal symptoms cited were dizziness, nausea, headache, paresthesia (tingling/numbness, usually in the limbs), vomiting, irritability and nightmares. About 10 percent of these patients had "severe" withdrawal symptoms. A longer and larger Lilly trial involving 1,279 patients found that 50 percent of patients experienced withdrawal symptoms.
FDA actions regarding Cymbalta
The FDA has moved slowly to address the dangers associated with Cymbalta. While the suicide of a teenage boy on Christmas Eve prompted them to add the strictest of warnings, the black box, which indicates the medication causes suicidal thoughts and behaviors.
They added other warnings as well:
- Liver disease (2005)
- Misleading ads (2005)
- Urinary retention warning (2008)
- Withdrawal symptoms (2009)
- Advisory committee review (2010)
- Blood pressure warning (2014)
- Serotonin Syndrome (2017)
- Takotsubo Cardiomyopathy, AKA Broken Heart Syndrome (2017)
What to do if Cymbalta causes issues
Your first step should be to speak with your doctor to rule out other health issues. Your second step should be to talk with a lawyer. Remember, each state has a different statute of limitations (AKA the time window in which to file your legal claim). Some states only offer one year to file a personal injury case, so do this sooner rather than later. An attorney can preserve your claim.
Do keep in mind that pharmaceutical cases take a long time to finish. It could be a decade before you see any type of real compensation.
For a case as complicated as this, you must get a lawyer with years of experience and who knows how to work with other attorneys. Consider looking through the Enjuris directory for someone in your state who can join your team.