Please note: The Schmidt Firm, PLLC is no longer accepting Cymbalta claims. If you feel that you may have a potential case, we urge you to locate another law firm adequately suited to handle your claim.
The antidepressant medication Cymbalta (duloxetine) has been associated with an increased risk of many serious side effects — including birth defects, suicidal behavior, and severe withdrawal symptoms. Although Cymbalta now carries a “Black Box” warning about the risk of suicide, many are concerned that the label does not adequately warn about the risk of withdrawal and serious fetal complications when it is used during pregnancy.
UPDATE: Judges Refuse to Centralize 25 Cymbalta Lawsuits in MDL
December 12, 2014 — Federal judges have refused plaintiffs’ request to centralize 25 lawsuits involving withdrawal side effects of Cymbalta into a Multi-District Litigation (MDL) under one judge. Instead, the cases will proceed individually. Click here to read more.
November 12, 2014 — A federal judge in New York has tossed a Cymbalta withdrawal lawsuit, ruling that the drug-maker adequately warned about the risk of severe withdrawal symptoms. The decision could hurt plaintiffs’ chances of consolidating dozens of similar lawsuits in federal court. Click here to read more.
September 15, 2014 — Law360.com reports that Eli Lilly & Co. has asked federal judges to deny a motion to centralize 28 lawsuits involving Cymbalya in a Multi-District Litigation (MDL). Click here to read more.
August 20, 2014 — Attorneys have asked a panel of judges to centralize 28 lawsuits involving severe withdrawal symptoms from Cymbalta into a Multi-District Litigation (MDL) in federal court in California. Click here to read more.
What is Cymbalta?
Cymbalta (duloxetine) is an oral medication that is primarily used to treat depression and anxiety. It was created by the drug company Eli Lilly & Co., and it was approved by the U.S. Food and Drug Administration (FDA) in 2004. Cymbalta is a type of antidepressant called an SNRI, or “serotonin-norepinephrine reuptake inhibitor,” which inhibits hormones and neurotransmitters in the brain that influence mood, emotions, and pain. Cymbalta has mild analgesic properties, and is also prescribed to treat diabetic neuropathy, osteoarthritis pain, and fibromyalgia.
Cymbalta Withdrawal Disorder
The link between Cymbalta and withdrawal was identified in the first clinical trials, before Cymbalta was approved by the FDA. Researchers from Eli Lilly & Co selected a group of patients with depression, who were given Cymbalta for 8-9 weeks. Then they were abruptly switched to a placebo and monitored another 1-2 weeks.
According to a report from the Institute for Safe Medicine Practices (ISMP), the study found that 44-50% of patients suffered withdrawal symptoms after discontinuing Cymbalta, of which 10% were “severe” symptoms. In nearly 54% of patients, the symptoms did not resolve after the 1-2 week monitoring period was over, and researchers did not follow-up beyond that period.
The medication guide does not state specifics about the risk of withdrawal. The label only includes this warning:
“Never stop an antidepressant medicine without first talking to a healthcare provider. Stopping an antidepressant medicine suddenly can cause other symptoms.”
These warnings do not explain how often “other symptoms” occur, how severe these symptoms might be, or what a patient can do to minimize their risk of symptoms when they discontinue Cymbalta (such as gradually tapering off the dosage). In the ISMP QuarterWatch report for the first quarter of 2012, there FDA received 48 reports of withdrawal. According to the ISMP, “A major lapse has occurred in the FDA-approved information for patients about the risk of stopping duloxetine.”
The ISMP was also concerned that the clinical studies of withdrawal only lasted 8-9 weeks, when most people who use Cymbalta take it for many months or years before discontinuing the drug.
Symptoms of Cymbalta Withdrawal
The symptoms of Cymbalta withdrawal may include physical and neurological symptoms. Reported symptoms include:
- Dizziness (which may include severe vertigo)
- Nausea, vomiting
- Paresthesia (or “tingling” sensations, including sensations in the brain many patients refer to as “brain zaps”)
- Abnormal sweating
- Anger, irritability
- Suicidal ideation
- Personality changes
- Changes in weight / appetite
Cymbalta and Suicide
Shortly after Cymbalta was approved, the FDA required that all antidepressant medications (including Cymbalta) must carry a “Black Box Warning” about the potential increased risk of suicidal ideation and behavior in teenagers and children. The Black Box is the most serious type of side effect warning.
In August 2012, the Eighth Circuit Court of Appeals ruled that a Cymbalta suicide lawsuit could move forward because Eli Lilly may have withheld important safety information — specifically, the fact that there were five suicides during clinical trials of Cymbalta.
The lawsuit was brought on behalf of a 16 year-old boy who was given samples of Cymbalta in 2004, before it carried the “Black Box” warning. His doctor was unaware of the suicides during clinical trials, and believed that Cymbalta had a lower risk of suicide than other antidepressants. Schilf committed suicide one month later in December 2004, and his parents sued Eli Lilly.
An appeals court found that the boy’s family may have a case against Eli Lilly for failing to warn about suicides in clinical trials. The opinion, in Paul Schilf v. Eli Lilly & Co., was dated August 3, 2012.
In April 2013, just one month before the lawsuit was set to go to trial, Eli Lilly agreed to an undisclosed settlement with the Schilf family, according to Indystar.com.
Cymbalta Class Action Lawsuit Information
In January 2013, Law360 reported that Eli Lilly & Co. asked a federal judge in California to toss a Cymbalta class action lawsuit. The class action sought compensation on behalf of everyone in California who purchased Cymbalta without adequate warnings about the risk of withdrawal symptoms, including “brain zaps.”
Our attorneys are not filing a Cymbalta class action — instead, we are reviewing cases and filing individual claims on behalf of people who were severely injured by Cymbalta. Contact us today for more information.
Cymbalta and Birth Defects
Cymbalta treats depression by inhibiting serotonin and norepinephrine (also known as an SNRI or “serotonin norepinephrine reuptake inhibitor”). Other antidepressants in the SNRI class include Effexor (venlafaxine) and Pristiq (desvenlafaxine). These drugs all pass to a developing baby, and they have all been associated with higher risks of pregnancy complications and birth defects.
Cymbalta Pregnancy Category
Cymbalta is a Pregnancy Category C medication. Drugs in this category are known to cause fetal harm based on animal studies, but studies in humans are inconclusive. The FDA recommends that Cymbalta should only be used during pregnancy if the benefits of treating depression outweigh any risks to a developing fetus.
Studies of Cymbalta Birth Defects
Cymbalta is associated with complications during pregnancy that can cause fetal death, although it is unclear if Cymbalta increases these risks. In February 2013, a study published in the International Journal of Medical Sciences linked Cymbalta to the following complications:
- Congenital abnormalities (birth defects)
- Spontaneous abortion
- Premature or post-term birth
- Ectopic pregnancy
- Neurobehavioral defects
Studies of other SNRI antidepressants, such as Effexor, have found higher risks of birth defects affecting the heart, skull, face, and abdomen. These birth defects include anencephaly, septal defects (“hole in the heart”), cleft palate, coarctation of the aorta, and gastroschisis.
Cymbalta Birth Defects
- Atrial Septal Defects
- Coarctation of the Aorta
- Gastroschisis – abdominal wall defect
- Cleft Palate
- Ventricular Septal Defects
- Ebstein’s Anomaly
- Mitral Valve Defects
- Transposition of the Great Arteries
- Tetralogy of Fallot
- Hypoplastic Left Heart Syndrome (HLHS)
- Hypoplastic Right Heart Syndrome (HRHS)
- Tricuspid Valve Stenosis
- Tricuspid Atresia
- Aortic Stenosis
- Patent Ductus Arteriosus (PDA)
- Truncus Arteriosus
- Heart Murmur
- Pulmonary Stenosis
- Pulmonary Atresia
- Esophageal Stenosis
- Esophageal Atresia
- Anal Atresia
- Spina Bifida
- Heart Malformations
- Neural Tube Defects
- Hand Deformations
- Cleft Lip
- Growth Restriction
- Persistent Pulmonary Hypertension of the Newborn (PPHN)
- Mental Retardation
- Autism spectrum disorder
- Down’s Syndrome
- Dandy Walker Syndrome
- Undescended Testicles
- Cloacal Exstrophy