Serzone Antidepressant Drug Patient Information

Very few patients and doctors take the time to read FDA issued label changes warning of serious and deadly Serzone antidepressant drug side effects that can occur. 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 Antidepressant Drug

FREQUENTLY ASKED QUESTIONS

What is Serzone antidepressant drug?
Who manufactures Serzone antidepressant drug?
Why has the FDA required that a Black Box warning be put on Serzone antidepressant drug labels?
What is liver damage caused by Serzone antidepressant drug?
What are some signs of liver damage caused by Serzone antidepressant drug?
 Why did Bristol-Myers warn Canadian physicians half a year before the U.S. of the risks associated to Serzone antidepressant drug?
What is a Black Box warning?
Are Black Box warnings effective?
Do I have any rights concerning Serzone antidepressant drug?

What is Serzone antidepressant drug?
Serzone antidepressant drug, generic name nefazodone hydrochloride, is prescribed for the treatment of depression with or without anxiety or sleeplessness. Since the 1994 FDA approval of Serzone, over 7 million Americans have used the antidepressant drug.

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Who manufactures Serzone antidepressant drug?
Bristol-Myers Squibb Company has generated $400 million in annual sales from Serzone antidepressant drug.

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Why has the FDA required that a Black Box warning be put on Serzone antidepressant drug labels?
Serzone antidepressant drug has been reported in at least 109 cases to cause liver damage. Liver damage caused by Serzone antidepressant drug has led to transplant and/or death.

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What is liver damage caused by Serzone antidepressant drug?
Liver damage caused by Serzone antidepressant drug can range from asymptomatic reversible serum transaminase increases to cases of liver failure that results in transplant and/or death. The time to report liver failure cases resulting in death or transplant generally ranges from two weeks to six months on Serzone therapy. Reports of liver damage in Serzone antidepressant drug patients has caused the FDA to order two label changes to strengthen the warning for the adverse side effects that have resulted from the drug's use.

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What are some signs of liver damage caused by Serzone antidepressant drug?
Signs of liver dysfunction in Serzone antidepressant drug patients include (but are not limited to):

  • Yellowing of the skin or the whites of the eyes (jaundice)
  • Unusually dark urine
  • Nausea
  • Abdominal pain
  • Loss of appetite that lasts several days or longer

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Why did Bristol-Myers warn Canadian physicians half a year before the U.S. of the risks associated to Serzone antidepressant drug?
The Canadian government told Bristol-Myers to send out letters to physicians after reports of deadly cases of liver failure in Serzone antidepressant drug patients was being reported back in June 2001. Bristol-Myers failed to warn U.S. physicians at this time because they claimed it was "specific to Canada." Finally, in December 2001, the FDA required Bristol-Myers to put the strongest warning the FDA issues, a Black Box warning, on Serzone antidepressant drug labels.

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What is a Black Box warning?
Black Box warnings are the strongest type of warning issued by the FDA. The "black box" refers to the thick black outline placed around the additional risk information that warns of death and serious injury associated to the drug. A Black Box warning was placed on all the Sezone antidepressant drug labels in December 2001 after the FDA reports found "cases of life-threatening hepatic failure have been reported in patients treated with Serzone."

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Are Black Box warnings effective?
FDA critics find Black Box warnings to be very ineffective because of the important information that is put in fine print in pages of patient information. In many instances, doctors have admitted to not reading drug labels despite any FDA changes that may have strengthened the precautions and risk of side effects.

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Do I have any rights concerning Serzone antidepressant drug?
Every consumer has the right to know about any adverse side effects that is known to occur. In cases like Serzone antidepressant drug, the side effects have been very serious and have led to death. Bristol-Myers knew that Serzone liver damage cases were being reported yet did not issue any warnings until the Canadian government and then the FDA required they take action against the antidepressant drug.


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Dangers of Serzone Antidepressant Drug
The type of liver damage Serzone antidepressant drug can cause ranges from asymptomatic reversible increases in serum transaminase to serious cases of liver failure. Liver damage that leads to instances of liver failure resulting in transplant and/or death has been associated to the use of Serzone antidepressant drug.
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 Antidepressant Drug