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Serzone: Drugs
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Serzone... known as nefazodone hydrochloride, is an antidepressant that fights mental depression by increasing natural substances in the brain. Serzone was approved by the FDA in December 1994. Since that time the FDA has requested, on at least eight separate occasions, that Bristol-Myers strengthen its warning on the drug. On December 7, 2001, the FDA required the company to add a black-box warning on Serzone, informing consumers about the increased risk of liver failure among patients who have taken the drug. A black-box warning is reserved for only the most serious side effects in medication.
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Serzone is a popular drug used to treat depression. While Serzone may be effective helping treat psychological problems, it may ... cause very serious physical side effects. The Canadian government first issued a health warning in July 2001. Bristol Myers removed Serzone from the market on May 20, 2004.
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Serzone tablets are taken by mouth. Serzone is usually started at a dose of 100mg twice daily, then increased by 100 or 200mg per day on a weekly basis depending on how you respond to the drug. Your doctor will decide which changes, if any, should be made to your dosage. Most patients' depression can be treated effectively with doses of 300 to 600mg per day. As with all antidepressants, Serzone may need to be taken for several weeks to obtain the full benefit of the drug.
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As reports of Serzone causing severe liver damage came about, the FDA took steps to warn physicians and patients of the dangerous side effect. In 2002, Serzone was required by the FDA to have a "black box warning" concerning liver damage, added to its packaging. The black box warning is the strongest warning available to the FDA without banning a drug from the market. The black box warning concerned the possible liver damage associated with Serzone and advised patients and physicians to watch carefully for liver problems. Patients were warned to watch for symptoms of liver disease, which include nausea, vomiting, loss of appetite, jaundice, and dark urine.
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Serzone was approved by the FDA for use in the United States for the treatment of depression in 1994. An anti-depressant in a class of its own in terms of its structure and composition, Serzone shares some characteristics with other serotonin uptake inhibitors like Prozac, Paxil and Zoloft. It is used to relieve feelings of sadness, worthlessness, or guilt; other symptoms of depression such as loss of interest in daily activities; changes in appetite; tiredness; sleeping too much; insomnia; and thoughts of death or suicide. The drug Serzone generates annual sales of $400 million for its manufacturer, Bristol-Myers Squibb. On May 19th, 2004, Bristol-Myers Squibb announced that due to declining sales, Serzone will no longer be sold in the U.S. after June 14th, 2004. This action does not affect sales of generic versions of Serzone (nefazodone).
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The metabolite of Serzone (nefazadone) is metabolized through CYP2D6 and CYP3A. Pharmacogenetic testing of these pathways serves as an anchor for the intense personalization required to effectively prescribe Serzone and other antidepressant medicines. Prevalent polymorphisms in genes for the cytochromes responsible for first pass metabolism of these, and many other drugs, cause differences in rate of drug clearance that result in dramatic differences in safety and efficacy. Physicians who incorporate pharmacogenetic drug reaction testing into their practice don't know how they had managed without that knowledge.
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