Viibryd (Vilazodone) Safety Label to Include Sleep Paralysis, Acute Pancreatitis
Viibryd (vilazodone) is a selective serotonin reuptake inhibitor (SSRI) manufactured by Forest Laboratories. According to a recent letter from the U.S. Food and Drug Administration (FDA), the warning label on Viibryd will be updated to include acute pancreatitis and sleep paralysis under the “Post-marketing Experience” section. In a Sept. 6, 2016 letter the agency writes to Forest Labs, “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.”
The U.S. Food and Drug Administration (FDA) approved Viibryd in 2011 to treat major depressive disorder (MDD) in adult patients. Like other SSRIs, it is meant to increase levels of serotonin, a chemical messenger thought to affect mood. Researchers believe that depression may be caused by low levels of serotonin.
eHealthMe, a medical analysis website intended as a database of consumer side effects, received 4,466 side effect reports among patients taking Viibryd through the FDA and social media. Among these, there were 13 reports of pancreatitis. The cases of pancreatitis reported by Viibryd were mostly among patients who were female, between the ages of 50 and 59, have been taking the drug for less than one month, patients taking the medication Levothyroxine and patients with depression.
Acute pancreatitis is a painful condition where the pancreas becomes inflamed. Some cases of acute pancreatitis can be life-threatening while others only lead to discomfort. Ten percent of acute pancreatitis cases are fatal despite advances in medicine, according to The National Pancreas Foundation. Initial symptoms of acute pancreatitis include a sudden or gradual pain in the upper abdomen that sometimes spreads to the back. Patients with acute pancreatitis often experience severe and constant pain, and most need hospitalization. Other symptoms include:
- Swollen and tender abdomen
- Nausea and vomiting
- Rapid pulse.
Being able to identify symptoms of acute pancreatitis quickly helps improve patient outcomes. In many instances, treatment is often not given right away because problems with the pancreas, an organ not easily accessible without surgery, can be difficult to diagnose.
Patients with symptoms of acute pancreatitis should seek medical attention immediately. Although most patients will recover with treatment, The National Pancreas Foundation says about 15 percent of patients develop severe acute pancreatitis, which is potentially fatal and can lead to the failure of multiple organ systems.
Sleep paralysis is when a person feels conscious but is unable to move in between the stages of wakefulness and sleep. People with sleep paralysis feel unable to move or speak and some experience a choking sensation. This condition does not lead to physical symptoms, but the experience is often described as frightening. WebMD notes that throughout history, people have often used “evil” spirits or demons to describe the feelings of terror accompanied by sleep paralysis.
The personal injury attorneys at Parker Waichman are investigating potential Viibryd lawsuits on behalf of individuals who experienced acute pancreatitis and sleep paralysis.
Other Side Effects Associated with Viibryd
The most common side effect reported among patients taking Viibryd are diarrhea and nausea. Other side effects include insomnia, dizziness and abnormal dreams.
Some side effects are more serious than others. 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
Viibryd carries a black box warning for suicidal thoughts and behavior in patients under the age of 25. A black box warning, also known as a “boxed warning”, is the most serious type of warning that can be placed on a drug label. The boxed warning on Viibryd states, “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.” Other SSRIs also carry this warning.
Another serious side effect that can occur with Viibryd, as well as other SSRIs, is serotonin syndrome. Serotonin syndrome is a potentially fatal condition caused by excessive amounts of serotonin. This can be triggered by using multiple products that increase serotonin, such as SSRIs, herbal supplements and illicit drugs.
Some patients may only experience mild symptoms such as shivering and diarrhea, while others may develop severe serotonin syndrome. These latter symptoms include high fever, seizures, irregular heartbeat and unconsciousness.
Serotonin syndrome can also cause changes in mental status such as agitation and hallucinations, delirium and coma, gastrointestinal symptoms, changes in heart rate, blood pressure, and temperature regulation.
Free Case Evaluations for Viibryd Lawsuits
If you or someone you know has questions about filing a Viibryd lawsuit, contact Parker Waichman drug injury attorneys today. Our firm offers free, no-obligation case evaluations. For more information, contact us or call 1-800-YOURLAWYER (1-800-968-7529).