By Donna Gregory Burch
When Lori Peterson’s doctor decided to switch her fibromyalgia medication from Cymbalta to Savella, she trustingly followed his instructions – a move that would land her on the couch for a week as she experienced Cymbalta’s withdrawal symptoms.
Diagnosed with fibromyalgia in 2007, Peterson had been using Cymbalta for three years and was taking 60 mg twice a day. While Cymbalta eased her symptoms for a while, it had stopped working, and Peterson was hoping Savella would finally bring some relief from the pain and fatigue of fibromyalgia.
“[My doctor] actually told me that I didn’t need to wean off of the Cymbalta as Savella was similar,” Peterson recalls. “I reduced the dosage of Cymbalta and then stopped. I then started the smallest dose of the Savella. After a couple of days, I could not sit up.”
For the next week, Peterson was so dizzy that she couldn’t go to work. She laid on her couch, unable to stand on her own.
“If I tried to sit up, my head was spinning so bad that I would just fall over,” she recalls. “I needed help getting to the bathroom and back.”
Peterson is just one of thousands of Cymbalta users affected by the drug’s high rate of withdrawal symptoms. A study by drug maker Eli Lilly and Company found 44 percent of patients experienced withdrawal symptoms, such as dizziness, nausea, headache, paresthesia, vomiting, irritability, nightmares and others, when they suddenly stopped taking Cymbalta. A larger, subsequent trial involving more than 1,200 patients found 50 percent of patients have withdrawal symptoms.
Since up to half of patients may experience these symptoms, physicians should know to wean patients off of Cymbalta slowly, but many, like Peterson’s doctor, aren’t aware of the drug’s risks.
And there’s a reason for that.
In Eli Lilly’s physicians’ prescribing guide for Cymbalta under the “discontinuation of treatment with Cymbalta section,” it reads, “Following abrupt or tapered discontinuation in adult placebo-controlled clinical trials, the following symptoms occurred at 1 percent or greater and at a significantly higher rate in Cymbalta-treated patients compared to those discontinuing from placebo: dizziness, headache, nausea, diarrhea, paresthesia, irritability, vomiting, insomnia, anxiety, hyperhidrosis and fatigue.”
Catch the discrepancy? Trials indicate 44-50 percent of patients have withdrawals. Eli Lilly’s prescribing guide says 1 percent or higher. Technically, it’s accurate, but it’s not the full story, and some doctors could infer from that 1 percent figure that withdrawal symptoms aren’t common.
This discrepancy between Eli Lilly’s prescribing literature and its actual research findings has prompted hundreds of former Cymbalta users to file suit against the drug maker, claiming the company didn’t fully disclose the severity or frequency of Cymbalta’s withdrawal symptoms. Thousands more cases are in the pipeline for filing, according to Baum, Hedlund, Aristei & Goldman, PC, one of the law firms involved in the legal action.
“The label gives the impression that withdrawal is a rare event (somewhere around 1 percent) when in fact it is common,” writes the law firm in a recent statement. “We think Lilly played with semantics and the system in choosing its wording; it chose wording to minimize the risk while at the same time using language such as ‘or greater’ as a CYA [cover your ass] measure. We believe the label is misleading, plain and simple. The testimony of the prescribing doctors in these cases proves it; they believed the risk was rare.”
It seems like a valid argument, but so far attorneys have been unsuccessful at convincing a judge or jury. The first three cases heard in federal court last year ended in verdicts for Eli Lilly.
Last August, plaintiff Claudia Herrera told California jurors that she felt “desperate” for months after she stopped taking Cymbalta. Her withdrawal symptoms included anxiety, dizziness, insomnia and brain zaps (which are described as feeling like a lightning bolt going off inside the head).
Eli Lilly’s attorneys argued it’s common knowledge that antidepressants cause withdrawal symptoms when stopped suddenly, and it’s standard practice for doctors to wean patients off of them. The jury bought Lilly’s argument and ruled in the company’s favor.
Later in August, plaintiff Erin Hexum’s trial was cut short by a California federal judge who ruled in Eli Lilly’s favor after Hexum’s physician testified that he couldn’t remember if he had read the physicians’ prescribing guide. The judge reasoned that if the physician couldn’t recall the guide, then how could Hexum’s attorneys argue that misleading information contained within it was responsible for her symptoms.
Hexum said she experienced severe cramping, requiring an emergency room visit, after she stopped taking Cymbalta for fibromyalgia. She has since been diagnosed with a seizure disorder and has lost her driving privileges.
Both Herrera and Hexum are appealing their cases.
In early September, a Virginia jury ruled against plaintiffs Gilda Hagan-Brown and Janine Ali, who claimed Eli Lilly was negligent in not fully disclosing Cymbalta’s withdrawal symptoms. Both women said they experienced depression, migraines, pain, fatigue and brain zaps after stopping Cymbalta in 2012.
To date, more than 200 plaintiffs have filed lawsuits against Eli Lilly. Attorneys have been unsuccessful in their attempts to consolidate these cases into a class-action lawsuit. Understandably, Eli Lilly’s attorneys have fought class-action status because it increases the chances of the company eventually having to pay compensation to thousands of affected patients.
The next Cymbalta case isn’t expected to be heard until late this year.
Have you been affected by Cymbalta’s withdrawal symptoms? Share your experience in the comments section!
About the Author: Donna Gregory Burch was diagnosed with fibromyalgia in 2014 after several years of unexplained symptoms. She’s written extensively about the Cymbalta withdrawal lawsuits on her fibromyalgia blog, including a helpful resources page at www.fedupwithfatigue.com/cymbalta-withdrawal-lawsuits. Donna is an award-winning journalist whose work has appeared online and in newspapers and magazines throughout Virginia, Delaware and Pennsylvania. She lives in Delaware with her husband and their many fur babies.