Serzone Antidepressant Patient Information

Very few patients and doctors take the time to read FDA issued label changes warning of serious and deadly Serzone side effects, including Serzone liver damage. Despite a Black Box warning being the strongest FDA warning issued, many doctors even admit not knowing the last time they have seen a drug label. While the FDA has been criticized for not being proactive enough when issuing warnings of possible death and serious side effects, a patient should take responsibility for reading their patient packet inserts and drug labels.

While these informational pamphlets are often hard to read with the fine print and loaded drug information, by educating yourself about the dangers and risks, as well as possible complications to be aware of, you can help prevent death or serious injury from occurring.

 

Serzone Liver Damage

The FDA advised Bristol-Myers Squibb Company on December 7, 2001 that their anti-depressant drug Serzone should contain black box warning labels cautioning drug users of the liver damage it has been linked to. Black box warning labels are the most serious warnings the FDA ever issues, which warns, "cases of life-threatening hepatic failure have been reported in patients treated with Serzone." The life-threatening liver damage has been estimated to occur at about 3-4 times the estimated background rate of liver damage. Figures are probably more conservative than the actual number of liver complications that have arisen due to Serzone use because of underreporting.

Liver damage has resulted in transplant and death. Certain symptoms that appear may indicate if a patient is developing a liver problem, including jaundice, nausea, anorexia, abdominal pain, and unusually dark urine. If you notice any of these adverse liver damage symptoms and have taken Serzone, immediately contact your doctor and contact us to learn your legal rights.

Other common Serzone side effects include headache, constipation, dry mouth, drowsiness, insomnia, nausea, vision problems, agitation, dizziness, fatigue, confusion, hypotension, rash or hives, seizures, and lightheadedness. In a study performed on Serzone prior to the marketing of the drug found 16% of the 3,496 patients taking Serzone discontinued their use due to side effects. Drowsiness was the most common side effect in Serzone users, experienced in varying dosages with the drug users.

Serzone should be avoided in any individuals who are:

  • Allergic to Serzone or Desyrel
  • Taking terfenadine, astemizole, cisapride, triazolam, pimozide, carbamazepine
  • Have liver damage or other problems
  • Taking or have taken within the last 14 days any of the depression medicines monoamine oxidase inhibitors should especially stay away from using Serzone because of the high risk of developing Serzone side effects.
  • In addition, anyone who has ever had liver damage or other problems, taking any other medicine, vitamin, herbal remedy, have heart problems, have had manic episodes, attempted suicide, have had seizures, or are pregnant or breast feeding should also be concerned with using, or thinking about using, Serzone antidepressant pills.

Serzone Liver Damage

Serious life-threatening Serzone liver damage and failure has been reported. There is one case of liver failure in the U.S. that results in death or a transplant for every 250,000-300,000 patient-years of Serzone treatment, a rate of 3-4 times the normal rate of liver failure. While this increased rate of Serzone liver damage and failure is substantially higher it still does not demonstrate the actual rate of Serzone liver damage due to underreporting.

The Serzone liver damage and liver failure cases that resulted in death or transplant normally ranged from 2 weeks to 6 months on Serzone therapy. Not all cases of these Serzone liver failures had prior symptoms indicating the resulting problems. There is no way of predicting if Serzone liver damage will occur in a patient, but signs of liver damage, including jaundice, anorexia, gastrointestinal complaints, and malaise should be immediately reported to your healthcare provider should any of these Serzone side effects surface.

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Dangers of Serzone Liver Damage
The type of liver damage Serzone can cause ranges from asymptomatic reversible increases in serum transaminase to serious cases of liver failure. Serzone liver damage leads to instances of liver failure resulting in transplant and/or death.
What is a Black Box Warning?
The FDA issues Black Box warnings when a drug is associated to a high risk of serious and deadly side effects. This type of warning is the strongest warning possible. Serzone's manufacturer, Bristol-Myers, was told in December 2001 that their antidepressant drug must include a Black Box to warn patients of the "life-threatening hepatic failure" that had been reported. The "black box" refers to the thick black outline that surrounds the warning.
 
 
 
Serzone Liver Damage