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drug_recall serzoneThe 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 failure has been estimated to occur at about 3-4 times the estimated background rate of liver failure. Figures are estimated to be more conservative than the actual number of liver complications that have arisen due to Serzone side effects because of underreporting.
Serzone liver complications have 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.
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.
Any individuals who are:
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 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. Serious life-threatening Serzone liver 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 failure is substantially higher it still does not demonstrate the actual rate of Serzone liver failure due to underreporting.
Cases of Serzone liver failures resulting in death or transplant normally ranged from 2 weeks to 6 months on Serzone therapy. Not all of these Serzone liver failure cases had prior symptoms indicating the resulting problems. There is no way of predicting if Serzone live failure will occur in a patient, but signs of liver dysfunction, including jaundice, anorexia, gastrointestinal complaints, and malaise should be immediately reported to your healthcare provider should any of these Serzone side effects surface.
Drug manufacturer Bristol-Meyers announced Wednesday that it will no longer make or sell Serzone, an antidepressant that has been linked to potentially deadly liver complications and has already been withdrawn in major markets including Europe and Can...
Public Citizen has sued the FDA, calling the agency "grossly negligent" for failing to issue a Serzone ban despite having already been taken off the market in Canada and Europe, with sales to end in Australia and New Zealand in May. The consumer watchd...