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Cymbalta

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Cymbalta is one of Eli Lilly's top-selling drugs, used for treating depression, anxiety, and bone and muscle pain. The drug carries some serious side effects, including discontinuation syndrome with brain zaps.

What is Cymbalta?

Cymbalta is a popular antidepressant that helps control neurotransmitters and hormones, improving moods and alleviating pain. Eli Lilly manufactured this multi-use, billion-dollar drug, which received FDA approval for alleviating mental and physical discomfort.

In 2004, the FDA also approved Cymbalta (duloxetine hydrochloride) to treat depression. Doctors soon began prescribing Cymbalta for a wide range of patients, including those with anxiety, diabetic neuropathy, muscle pain and stress urinary incontinence.

In 2007, the FDA added the treatment of fibromyalgia - a type of arthritis characterized by muscle pain, trouble sleeping, and tiredness - to Cymbalta's label.

Unfortunately, patients wishing to discontinue use of the drug often suffer from side effects that impair their health, ones that can last weeks after stopping Cymbalta treatment. These withdrawal symptoms range from headaches and dizziness to suicidal ideation and blackouts.

Cymbalta and Other Antidepressants

Cymbalta makes up a major share of the $11 billion-a-year antidepressant market and competes with drugs like Paxil, Lexapro and Effexor. In 2012, it accounted for 42 percent of antidepressant sales.

Like Effexor, Cymbalta works as a serotonin-norepinephrine reuptake inhibitor (SNRI). The SNRI drug class deals with norepinephrine and aims to improve energy levels. Similar to SSRIs, Cymbalta also deals with serotonin levels, which can lift moods.

A Top Seller for Eli Lilly

Since the drug's approval in 2004, Eli Lilly has brought in more than $29 billion. At its peak, in 2013, it had annual sales of $5 billion.

High Costs for Patients

The brand-name drug sells for retail prices of more than $170 a month—making the drug more expensive than many antidepressants on the market.

Cymbalta Uses and Clinical Studies

Over the past decade, Cymbalta indications expanded to include anxiety, diabetic neuropathy, fibromyalgia and chronic muscle pain. Internationally, the drug is also approved for treating stress urinary incontinence.

FDA Approvals

The FDA initially approved the drug for treating depression, and within a year approved it for diabetic neuropathy. For diabetic neuropathy, Cymbalta treats pain and tingling from nerve damage. In 2007, generalized anxiety disorder – a condition that more than 6 million Americans suffer from every year – was put on the list.

Growing Popularity

Within five years of the drug hitting the market, doctors prescribed 2.8 million patients Cymbalta, according to an FDA staff report. Of these prescriptions, 400,000 were prescribed for off-label uses like nerve pain, musculoskeletal pain and headaches. In 2008, the FDA approved its use for Fibromyalgia. Analgesic properties make the drug also suitable for osteoarthritis.

Advisory Committee Meets

Because of reports of serious side effects like liver damage and skin disease, an FDA advisory committee met in 2010 to review whether or not the benefits outweighed the risks in the use of Cymbalta for treating chronic pain. Despite this danger, the drug was approved months later for chronic musculoskeletal pain, including osteoarthritis.

Side Effects of Cymbalta

Patients taking Cymbalta are often unaware of the potential side effects that may occur, and doctors continue to prescribe it for more uses despite these dangers.

  • Complications for Pregnant Women
  • Birth Defects
  • Skin Disease
  • Suicidal Thoughts
  • Liver Toxicity

Discontinuation Syndrome

Persistent Withdrawal Symptoms (Brain Zaps)

The Institute of Safe Medication Practices (ISMP) published a report describing 48 instances where Cymbalta users suffered from debilitating withdrawal side effects, including brain zaps.

While a brain zap is not a precise medical term, many Cymbalta users have experienced the same type of abrupt electrical shock disrupting their mind. They describe the zaps as intense and painful sensations that cloud mental clarity and leave them with shakes, nausea and headaches. The degree of severity can impair a patient's ability to work, socialize and carry out daily tasks.

ISMP's reported Cymbalta withdrawal side effects include:
Dizziness Brain zaps
Anger Suicidal thoughts
Weight gain Paresthesia (burning sensation)

Clinical studies reveal that with abrupt discontinuation of the drug, similar symptoms occurred in nearly half of patients. Of those, 10 percent felt symptoms acutely and half continued to suffer from side effects more than one to two weeks after stopping treatment.

Many of these patients required hospitalization and also reported nausea, tremors and blackouts. The ISMP also noted that communications from the FDA and Eli Lilly to the public, regarding these safety concerns, were insufficient.

Warnings

The United States, Australia, the European Union and the United Kingdom added numerous warnings to Cymbalta, according to the Citizens Commission on Human Rights (CCHR), a non-profit mental health watchdog.

In 2005, the FDA censured Eli Lilly regarding professional journal ads that provided misleading information about Cymbalta. It sent a letter to Eli Lilly describing the misleading portion of ads as failing to disclose important risks and side effects. While the ads were discontinued, the dangers remain.

The CCRH reported warnings concerning:

  • Suicidal thoughts and behaviors
  • Serotonin syndrome
  • Aggression
  • Birth defects
  • Death

Cymbalta Lawsuits

People struggling with severe withdrawal symptoms related to Cymbalta use can take action and file lawsuits against the drug's manufacturer for not properly warning users of the drug's danger.

Jennifer Saavedra v. Eli Lilly & Co.

California resident Jennifer Saavedra suffered from Cymbalta withdrawal, experiencing nausea, brain zaps and tunnel vision. She and three other plaintiffs who also experienced severe withdrawal effects filed a class action lawsuit against the manufacturer in January 2013. As of August 2014, the case is unresolved.