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Serzone
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Serzone® (Nefazodone Hydrochloride) is thought to treat severe depression by correcting an imbalance in the amounts of certain natural chemicals, such as serotonin and norepinephrine. However, it is reported that no significant improvements in mood or behavior can be noted for 6-8 weeks after initial treatment has begun. This drug has a list of quite severe side effects that you must be aware of and should be monitored by a qualified physician. Serzone® (Nefazodone Hydrochloride) and over 800 other drugs have been implicated in causing liver disease.
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With the generic name of nefazodone hydrochloride, Serzone is manufactured as an antidepressant by Bristol-Myers Squibb Co. Serzone is linked to 26 deaths that were the result of severe liver damage. On January 8th, 2003, the drug was banned from all European countries due to the aforementioned fatalities. The FDA has ordered Bristol-Myers Squibb Co. to include a "black-box" warning label on the antidepressant advising patients of those that have experienced life-threatening liver failure caused by the consumption of the drug. The black box title refers to a black outline surrounding the warning details and is reserved for only extreme side effects. The black box is considered the most serious warning that can be issued by the Federal Food and Drug Administration.
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Serzone tablets contain nefazodone hydrochloride. Nefazodone hydrochloride is a medicine which can correct the imbalance of certain chemical substances that can occur within the brains of depressed people. Restoration of the normal balance of these brain chemicals returns brain function to normal and lifts depression, usually within a few weeks of starting the medicine. Nefazodone hydrochloride is a different type of antidepressant to any currently in use. Your doctor will tell you why you need to take Serzone. Never let any one else take your medicine.
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Following reports of liver failure in Serzone users, the FDA required Bristol-Myers to place a "black box" warning on the Serzone packet insert. In January, 2003 Serzone was withdrawn from the market in Europe. In November, 2003, Serzone was withdrawn from the market in Canada. In early 2004 Public Citizen, a safety watchdog organization, filed a lawsuit intended to force the FDA to withdraw Serzone from the market. Although it continues to assert that the medication is safe, in May, 2004, citing "business reasons", Bristol-Myers announced that it would stop manufacturing Serzone.
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Serzone has been linked to dangerous physical side effects, namely liver toxicity, liver failure and other hepatic injuries. Serzone has been linked to at least 55 cases of liver failure, including 20 deaths and another 39 cases of severe liver injury. The reported rate of liver failure in the U.S. for individuals taking Serzone is about 3-4 times greater than the rate of non-users. Serious liver damage usually occurs within four months of initial treatment. However, there are cases of liver injury that have occurred within a few weeks of initial treatment with Serzone or after continuous use for up to one or two years. Symptoms of liver complications include yellowing of the skin or eyes, dark or discolored urine, loss of appetite that lasts for at least several days, stomach pains and nausea.
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Serzone is no longer sold in Europe or Canada. Bristol–Myers Squibb will withdraw the drug from Australia and New Zealand markets by the end of May. In the United States, an FDA black box on the package insert for Serzone warns about the risk of liver failure. The company literature ... admits that the rate of liver failure resulting in death or transplant in Serzone users is about three to four times the level of liver failure in those not taking the drug. Neither the black box warning or the company literature goes far enough to protect patients from Serzone, according to Public Citizen. “The FDA has a legal responsibility to protect the public from unsafe drugs, and it is shirking that duty,” said Michael Kirkpatrick, the author of the Public Citizen complaint.
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