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Viibryd Side Effects: Linked to Pancreatitis and Serotonin Syndrome

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Viibryd (vilazodone hydrochloride) Update: New FDA Warning

In January 2017, the US Food and Drug Administration (FDA) issued a mandatory label update for Viibryd (vilazodone hydrochloride), requiring that the label now include a warning stating the risk of serotonin syndrome. The new warning states: “Serotonin Syndrome: Increased risk when co-administered with other serotonergic agents (e.g. SSRI, SNRI, triptans, amphetamines), but also when taken alone.”

What exactly does this new warning mean?


TheLawFirm.com Sidebar: What is serotonin?

Serotonin is a neurotransmitter located primarily in the gastrointestinal (GI) tract that performs a wide range of important functions throughout the body, many of which still are not well understood. In the central nervous system (CNS), serotonin helps in the regulation of mood, appetite, sleep, memory, and learning. In the blood, the release of serotonin plays an important role in stimulating the coagulation of platelets. In the gut, serotonin controls motility, or the contraction of the muscles in GI tract.

Serotonin Syndrome. According to the US National Library of Medicine, serotonin syndrome (SS) is a drug-induced condition resulting in an excess of serotonin in the body. Most frequently, serotonin syndrome occurs when multiple medications impacting the body’s serotonin levels are taken simultaneously, causing the buildup of unhealthy amounts of the naturally occurring neurotransmitter. However, as the FDA warns, serotonin syndrome also has been diagnosed in patients taking Viibryd by itself.

Serotonin is found primarily in the gastrointestinal tract, where approximately 90% of the body’s serotonin is concentrated, with the remaining 10% spread between the central nervous system (CNS) and blood platelets, which cannot produce serotonin themselves but acquire it from the surrounding plasma. Despite its heavy concentration in the gastrointestinal (GI) tract, the effects of serotonin are experienced primarily by the cardiovascular system, as well as the respiratory system, the central nervous system, and the intestines.

An excess of serotonin can impact a host of essential bodily functions in ways ranging from the mild to the life-threatening. From a mental health perspective, serotonin syndrome can cause feelings of agitation, restlessness, and confusion, while in the digestive system, it can result in severe diarrhea. Serotonin syndrome also can produce abnormalities in the functioning of muscle tissue, which reveal themselves in the form of symptoms like involuntary twitching of the muscle, loss of muscle coordination, and muscle rigidity, an extremely painful and debilitating condition. The cardiovascular system—highly dependent on serotonin for its proper functioning—can be subject to high blood pressure, increased heart rate, and an irregular heartbeat in patients suffering from serotonin syndrome. The central nervous system (CNS) also can be heavily impacted, sometimes resulting in seizures or a loss of consciousness.

Sometimes, serotonin syndrome can be treated simply by ceasing treatment with the offending medication(s). In other cases, patients may be given a drug intended to block serotonin uptake until the body’s serotonin returns to a safer level.

While often associated with prescription medications designed to affect the body’s serotonin levels, according to the National Library of Medicine, serotonin syndrome also has been observed in patients using recreational drugs “such as ecstasy, LSD, cocaine, and amphetamines.”

If you or a loved one has suffered serious complications while taking Viibyrd, the expert team of attorneys at TheLawFirm.com are standing by now for a free consultation.


TheLawFirm.com Sidebar: The Signs of Serotonin Syndrome

According to the Mayo Clinic, the signs of serotonin syndrome include:

  • Agitation / restlessness
  • Confusion
  • Rapid heart rate
  • High blood pressure
  • Dilated pupils
  • Loss of muscle coordination
  • Twitching muscles
  • Muscle rigidity
  • Heavy Sweating
  • Diarrhea
  • Headache
  • Shivering
  • Goose Bumps
  • Fever
  • In some instances, serotonin syndrome can result in serious conditions such as:
  • Seizures
  • Irregular heartbeat
  • Loss of consciousness
  • The Mayo Clinic recommends seeking immediate medical attention if you experience the signs and symptoms of serotonin syndrome following a recent change in medication.

    Other Serotonergic Agents. The revised FDA label warns of an increased risk of serotonin syndrome when Viibryd “is co-administered with other serotonergic agents (e.g. SSRI, SNRI, triptans, amphetamines).” So, what are these “other serotonergic agents”?

    SSRIs. Selective serotonin reuptake inhibitors (SSRIs)—of which Viibryd is one—were developed to treat cases of moderate to severe depression while, in theory, causing fewer of the many side effects associated with the previous generation of anti-depression drugs.

    SSRIs work by boosting the levels of serotonin in the brain, thereby reducing feelings depression. According to the Mayo Clinic, SSRIs increase serotonin levels by blocking “the reabsorption (reuptake) of serotonin in the brain, making more serotonin available.” SSRIs are deemed to be “selective” in that “they seem to primarily affect serotonin, not other neurotransmitters.”


    TheLawFirm.com Sidebar: FDA-approved SSRIs

    The US Food and Drug Administration (FDA) has approved a number of selective serotonin uptake inhibitors (SSRIs) for the treatment of moderate to severe depression, and, in some instances, other conditions such as anxiety.

    According to the Mayo Clinic, FDA-approved SSRIs include:

  • Celexa (citalopram)
  • Lexapro (escitalopram)
  • Prozac (fluoxetine)
  • Paxil, Pexeva (paroxetine)
  • Zoloft (sertraline)
  • & Viibryd (vilazodone)
  • SNRIs. Serotinin and norepinephrine reuptake inhibitors (SNRIs) belong to a category of medications prescribed for the treatment of a variety of conditions including depression, anxiety disorders, and chronic nerve pain. SNRIs often are used to treat individuals suffering from both depression and long-term pain.

    Like SSRIs, SNRIs operate by blocking the reuptake of serotonin, thereby increasing the levels of serotonin in the brain. Unlike SSRIs, however, SNRIs also block the reabsorption of norepinephrine, a substance strongly associated with the body’s fight-or-flight response that also is involved in a number of important bodily functions, such influencing the force of muscle contractions (including the rate and force of heart contractions). Functioning in different capacities as both a neurotransmitter and a hormone, norepinephrine is found primarily in the neurons of the central nervous system, but also is stored in small amounts in the tissue of the adrenal gland.

    As with the majority of antidepressant drugs on the market, SNRIs function by changing the chemistry within the patient’s brain, interfering with the way nerve cells communicate with one another in an effort to alleviate depression and, in some cases, anxiety and/or chronic pain.


    TheLawFirm.com Sidebar: FDA-approved SNRIs

    The US Food and Drug Administration (FDA) has approved several SNRIs for the treatment of depression, anxiety, and/or chronic nerve pain. According to the Mayo Clinic, FDA-approved SNRIs include:

  • Pristiq, Khedezla (desvenlafaxine)
  • Cymbalta (duloxetine)
  • Fetzima (levomilnacipran)
  • Effexor XR (venlafaxine)
  • Triptans. Triptans are a category of drug used frequently in the treatment of migraine headaches that, similar to SSRIs and SNRIs, operate by increasing the levels of serotonin in the brain. According to the National Institutes of Health (NIH), raising serotonin levels helps alleviate migraine symptoms by inducing the constriction of blood vessels and lowering the pain threshold. Triptans presently are the primary treatment for migraine headaches and are available in various forms, including tablets, nasal sprays, and injections.


    TheLawFirm.com Sidebar: FDA-approved Triptans

    According to the US Food and Drug Administration (FDA), taking triptans—a common migraine treatment—in conjunction with Ziibryd increases one’s risk of serotonin syndrome. The Mayo Clinic identifies the following FDA-approved triptans, currently the go-to treatments for migraine sufferers:

  • Imitrex (sumatriptan)
  • Maxalt (rizatriptan)
  • Axert (almotriptan)
  • Amerge (naratriptan)
  • Zomig (zolmitriptan)
  • Frova (frovatriptan)
  • Relpax (eletriptan)
  • Amphetamines. Amphetamines belong to a class of drugs known as stimulants, which speed up the rate at which signals travel between the brain and the body. While some amphetamines are FDA-approved for legitimate medical purposes, amphetamines also are popular street drugs, used recreationally or as a performance enhancer.

    Prescribed by a medical professional, amphetamine-based medications are used in the treatment of a wide range of conditions, from obesity to narcolepsy to attention deficit hyperactivity disorder (ADHD). However, amphetamines are dangerous due to their highly addictive nature, particularly when combined with other drugs such as dextroamphetamines. (Dextroamphetamine and amphetamine are regularly prescribed in combination with one another for the treatment of ADHD in children and adults.)

    Amphetamines—whether taken illegally or under the guidance of a medical professional—are dangerous when taken in conjunction with Viibryd, as it significantly increases the risk of serotonin syndrome.


    TheLawFirm.com: Legal Amphetamines

    Frequently, we hear of amphetamines as dangerous street drugs with slang names like base, crystal, glass, or ice. However, a number of amphetamine-based drugs have been approved by the US Food and Drug Administration (FDA) for the treatment of conditions like ADHD, narcolepsy, and obesity. The list of FDA-approved amphetamine-based medications include well-known drugs such as:

  • Adderall
  • Adderall XR (extended release)
  • Mydasis
  • Viibryd Effects on the pancreas - FDA Warning

    The powerful antidepressant medication Vilbryd has been linked with acute pancreatitis. And acute pancreatitis often leads to pancreatic cancer, which is almost always fatal.

    Depression is a serious health issue that affects millions of people. The attorneys at TheLawFirm.com believe, however, that choosing to treat your depression with a prescription medication should not present you with a life-or-death choice.

    Yet Vilbryd, despite its links with the potentially fatal condition acute pancreatitis – and despite the fact that the U.S. Food and Drug Administration (FDA) has issued a formal waning about it – remains on the market.

    On September 6, 2016, the FDA wrote a letter to Forest Labs about Viibryd. Viibryd was approved by the FDA in 2011 for the treatment of major depressive disorder in adults. By 2014 Viibryd became the third-most prescribed antidepressant.

    We believe that this is an unacceptable situation.

    At TheLawFirm.com, we have dedicated ourselves to seeking justice for clients who have seen Big Pharma toy with their health and well-being.

    Viibryd Side Effects: Acute Pancreatitis

    The pancreas is one of the most important organs in the body. It produces hormones that are essential to the body’s metabolic functions, and also secretes chemicals that play essential roles in the digestion of food. The pancreas is a multitasker. Precisely because the pancreas is crucially involved with numerous, essential body functions, any damage to it can result in very serious health complications – even death.

    Acute pancreatitis occurs when the pancreas suddenly becomes inflamed. The condition usually results in hospitalization, and is fatal about 10% of the time. Victims of acute pancreatitis usually endure severe pain. What is frightening is that up to 25% of patients who develop acute pancreatitis will experience a recurrent episode within the first several years. If acute pancreatitis recurs, the risk of pancreatic cancer is greatly increased. This form of cancer is almost always fatal.

    Other Viibryd Side Effects

    Acute pancreatitis is not the only serious side effect that has been associated with Vilbryd. This powerful antidepressant has also been connected with a host of other conditions, including but not limited to:
    • diarrhea
    • erectile dysfunction
    • headaches
    • vomiting
    • dizziness
    • insomnia

    In the worst cases, Vilbryd has been linked with more serious conditions, such as:
    • serotonin syndrome, a condition in which body temperature is elevated, muscles can tense up, and heart rates can be rendered irregular; and
    • mania or hypomania, a potentially dangerous state of artificial elation or manic behavior.

    Additionally the attorneys at TheLawFirm.com expect new warnings related to sleep paralysis will also be added to the Viibryd label and prescribing information.
    Sleep paralysis is a condition in which a person is awake but cannot move or speak. Generally, sleep paralysis occurs upon waking and lasts less than one minute. Although sleep paralysis is a serious condition, and can cause psychological harm in the most severe cases, the condition is generally not life threatening.

    Viibryd and Depression

    Getting your depression under control is one of the best things you can do for your health. But if controlling your depression means putting your overall health at risk – well, we think there should be other, better solutions.

    If you’ve taken Vilbryd to treat your depression, you could be at serious risk and should consult your doctor immediately.

    Once you’ve spoken with your doctor, contact TheLawFirm.com. We can help you obtain the justice and financial compensation to which we believe you are entitled.

    You pay us nothing unless and until we win your case.

    Call TheLawFirm.com today for your free consultation.

    Get Help Now!

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