Sleep Paralysis, Acute Pancreatitis Added to Viibryd Side Effects. The national law firm Parker Waichman LLP is investigating potential lawsuits on behalf of Viibryd users who suffered sleep paralysis or acute pancreatitis.
According to a letter from the U.S. Food and Drug Administration (FDA) to drug maker Forest Laboratories, the warning label on Viibryd (vilazodone) will be updated to include acute pancreatitis and sleep paralysis as potential side effects. These adverse events will be added to the “Post-marketing Experience” section in the safety information.
The FDA stated in the Sept. 6 letter, “This supplemental new drug application provides for the addition of sleep paralysis and acute pancreatitis to the Post-marketing Experience subsection (6.2) consistent with our May 31, 2016, and June 8, 2016 letters.”
Viibryd is a selective serotonin reuptake inhibitor (SSRI), a class of medications that is used to treat depression by raising levels of serotonin in the body. Serotonin is a chemical messenger thought to affect mood. Viibryd was approved in 2011 to treat major depressive disorder (MDD) in adults.
Acute pancreatitis is the sudden inflammation of the pancreas
Acute pancreatitis is the sudden inflammation of the pancreas. It can be life-threatening in some cases, although most patients recover with the right treatment. The National Pancreas Foundation notes that ten percent of acute pancreatitis cases are fatal despite advances in medicine.
Recognizing symptoms of acute pancreatitis can improve a patient’s prognosis, especially since diagnosis can be difficult. Acute pancreatitis symptoms usually begin with a sudden or gradual pain in the upper abdomen. The pain, which is often severe and constant, sometimes spreads to the back. In most patients, acute pancreatitis requires hospitalization. Other acute pancreatitis symptoms include:
- Swollen and tender abdomen
- Nausea and vomiting
- Rapid pulse.
Individuals who suspect they have acute pancreatitis should seek medical attention right away. The National Pancreas Foundation estimates that about 15 percent of acute pancreatitis cases become severe and cause the failure of multiple organ systems.
eHealthMe, a medical analysis website that collects information about drug side effects for the consumer, obtained 4,466 side effect reports associated with Viibryd through the FDA and social media. Among these, 13 reported pancreatitis; these patients were typically female, between the ages of 50 and 59, have been taking the drug for less than one month, taking the medication Levothyroxine and had depression.
Sleep paralysis is a potential Viibryd side effect that does not lead to physical harm, but can have psychological impacts on some people. Individuals with sleep paralysis feel conscious but cannot move or speak; it occurs between the stages of sleep and wakefulness.
In some cases, sleep paralysis is associated with a choking sensation. Many people with sleep paralysis describe the experience as frightening. In fact, WebMD notes that throughout history, sleep paralysis has often been attributed to “evil” spirits or demons. These stories highlight the terror felt by people who experience sleep paralysis.
What Other Adverse Events are Associated with Viibryd?
Patients taking Viibryd may experience other side effects as well, some being minor and others more serious. Common side effects that can occur while taking Viibryd include nausea, diarrhea, insomnia, dizziness and abnormal dreams.
One of the serious side effects associated with Viibryd, as well as other SSRIs, is the risk of suicidal thoughts and behavior in children and adolescents. The FDA has mandated its most serious “black box warning” also known as a “boxed warning” to disclose this risk.
The warning reads “Antidepressants increased the risk of suicidal thoughts and behaviors in patients aged 24 years and younger in short-term studies. Monitor closely for clinical worsening and for emergence of suicidal thoughts and behaviors. The safety and efficacy of VIIBRYD have not been established in pediatric patients.”
Serotonin syndrome, a potentially fatal condition caused by too much serotonin, is another potential side effect associated with Viibryd and other SSRIs. Serotonin syndrome is more likely to occur in patients who take more than one product that increases serotonin levels, such as SSRIs, herbal supplements and illicit drugs.
The symptoms and severity of serotonin syndrome can range; mild cases may only lead to shivering and diarrhea, for example. Symptoms of severe serotonin syndrome include high fever, seizures, irregular heartbeat and unconsciousness.
Other symptoms of serotonin syndrome include changes in mental status such as agitation and hallucinations, delirium and coma, gastrointestinal symptoms, changes in heart rate, blood pressure, and temperature regulation.
According to Drugs.com, patients taking Viibryd should seek medical attention right away if they experience the following symptoms:
- Involuntary movements
- Tingling feelings or the sensation of burning, crawling, itching, numbness, pricking or “pins and needles”
- Chest pain or discomfort
- Extra heartbeat or fast, irregular heartbeat or pulse
- Shakiness or trembling in the legs, arms hands or feet
- Excited talking, feeling or actions
Paxil (paroxetine) Lawsuits and Settlements
Personal injury attorneys at Parker Waichman note that lawsuits have also been filed over other SSRIs, including Paxil (paroxetine). Paxil manufacturer GlaxoSmithKline has settled both state and federal allegations of off-label marketing with Paxil, along with Wellbutrin and Advair.
Off-label means that a drug is being used in a manner not approved by the FDA. Physicians can prescribe drugs off-label if they believe it will benefit the patient, but it is illegal for pharmaceutical companies to promote their products for unapproved uses.
In 2012, GSK agreed to pay an unprecedented $3 billion to resolve federal government allegations that it marketed Paxil, Wellbutrin and Advair off-label. With Paxil, the government alleges that GSK unlawfully marketed the antidepressant for patients under the age of 18, even though the FDA has not approved Paxil for children. At the time, the Department of Justice said it was the largest health care fraud settlement in U.S. history.
More than 40 states also alleged that GSK promoted Paxil off-label for use in children. In 2014, the drug maker agreed to pay $105 million to settle off-label allegations with Paxil, Wellbutrin and Advair.
“GlaxoSmithKline put its business interests ahead of what was best for vulnerable patients,” said Illinois attorney general Lisa Madigan, who announced the settlement. “This settlement will put a stop to the illegal marketing practices the company used to boost its sales.”