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nefazodone (SERZONE)

• nefazodone (SERZONE)
  We list this drug as a Do Not Use drug because it causes liver failure.

• Depression: When are Drugs Called For And Which Ones Should You Use? [hide all summaries]
  Ironically, one of the kinds of depression that should not be treated with drugs is depression caused by other kinds of drugs. If someone is depressed and the depression started after beginning a new drug, it may well be drug-caused. Commonly used drugs known to cause depression include the following:

• Serotonin Syndrome Due to Drug Interactions [hide all summaries]
  (April 2008)
  The article lists more than 30 prescription drugs that can cause the serotonin syndrome.
• FDA: All Antidepressants Should Carry Warnings About Risks of Suicidal Thoughts in Young Adults [hide all summaries]
  (July 2007)
  Because of new information about increased risks of suicidal thoughts associated with the use of a variety of antidepressants, people of all ages should be monitored closely with all antidepressants after the drugs are first prescribed, switched or when the dosage is changed. Do not stop using any antidepressants without first consulting the prescriber.
• Black Box Warning To Be Required On All Antidepressants Concerning Suicide Risk In Children And Adolescents [hide all summaries]
  (December 2004)
  Belatedly, the Food and Drug Administration (FDA) announced on October 15, 2004 that it is taking steps to inform parents and physicians about the risks of antidepressants when these drugs are used to treat major depressive disorder in children and adolescents.
• Suicide Risk Added To The Professional Product Labeling For Eight Antidepressants [hide all summaries]
  (August 2004)
  At the request of the Food and Drug Administration (FDA), eight out of ten manufacturers of newer antidepressants have agreed to add a warning about the possibility of an increased risk of suicide associated with the use of these drugs. The warning will appear in the professional product labeling, or package insert, for these drugs.(listed in the article)
• Dangerous Antidepressant Nefazodone (SERZONE) Now Withdrawn From the Market in Europe, Canada, Australia and New Zealand [hide all summaries]
  (June 2004)
  In March, 2003 Public Citizen’s Health Research Group first petitioned the FDA to ban this uniquely dangerous antidepressant because of liver toxicity (see Worst Pills, Best Pills News March 2003).  As the toll of liver damage and death continued to rise, we amended our petition (see Worst Pills, Best  Pills News December 2003) and in March of this year we filed a lawsuit in U.S. District Court for the District of Columbia against the FDA because they had failed to act on our petition.
• CBS Evening News on Serzone: New Concerns Over Anti-Depressant [hide all summaries]
  (June 2004)
  On April 15th of this year, the CBS Evening News asked Dr. Sidney Wolfe of Public Citizen "Is there any legitimate reason this drug should still be sold in the U.S. when it’s been taken off the market in other places for the same dangers?" Dr. Wolfe replied, "From a financial perspective, the only reason is to make money for Bristol Myers Squibb. But from a health perspective there is no justification for this drug being on the market."
• The Antidepressant Fluoxetine (Prozac) and Suicidal Ideation — Déjà vu 1991 [hide all summaries]
  (May 2004)
  Fourteen years ago, in May 1991, the Health Research Group petitioned the Food and Drug Administration (FDA) to require a warning in the professional product labeling, or package insert, of fluoxetine (PROZAC) concerning the risk of suicidal impulses in patients using the drug. Fluoxetine belongs to the family of antidepressants known as selective serotonin re-uptake inhibitors, or SSRIs. Read the warning we asked for back then.
• Updates: Rosuvastatin (CRESTOR) and Nefazodone (SERZONE) [hide all summaries]
  (April 2004)
  This article discusses why there is no medical reason that you or a family member should be taking either rosuvastatin or the anti-depressant nefazodone.
• DO NOT USE! Dangerous Antidepressant Nefazodone (SERZONE) Withdrawn From The Market In Canada HRG Files Second Petition to Ban Nefazadone [hide all summaries]
  (December 2003)
  Nefazodone (SERZONE), a dangerous antidepressant long linked to liver toxicity and deaths, was withdrawn from the Canadian market effective November 27, 2003. The drug is produced by Bristol-Myers Squibb in both Canada and the U.S.
• FDA Issues Public Health Advisory On Antidepressants And Suicide Risk In Children [hide all summaries]
  (December 2003)
  The Food and Drug Administration (FDA) issued a Public Health Advisory on October 27, 2003 about reports of suicidal thinking and suicide attempts in clinical trials of eight drugs in pediatric patients with major depressive disorder (MDD).
• Important Safety Alert! Antidepressant Nefazodone (SERZONE) Withdrawn From the Market In All European Countries [hide all summaries]
  (March 2003)
  Bristol-Myers Squibb of Princeton, NJ announced on January 8, 2003 that it will pull the antidepressant nefazodone (SERZONE) in all European countries where it is marketed. The drug was withdrawn from the Swedish market in early 2002 and from Denmark in December 2002 after concerns about liver toxicity. If you or a family member are currently taking nefazodone, discuss with the prescribing physician switching to one of the numerous other, safer antidepressant drugs now on the market.
• Drug Induced Psychiatric Symptoms (Part 2) [hide all summaries]
  (November 2002)
  This is the second of a two-part series on drug-induced psychiatric symptoms that began in last month’s Worst Pills, Best Pills News. The information is based on the July 8, 2002 issue of The Medical Letter on Drugs and Therapeutics. Article lists drugs and adverse effects.
• Grapefruit Juice and Drug Interactions [hide all summaries]
  (June 2002)
  Grapefruit juice can interact with a number of therapeutically important drugs that could lead to the possibility of toxicity. These drugs are listed in the article.
• Do Not Use! Life-threatening Liver Toxicity with the Antidepressant Nefazadone (SERZONE) [hide all summaries]
  (February 2002)
  The Food and Drug Administration (FDA) informed pharmaceutical giant Bristol-Myers Squibb Co. on December 10, 2001 that it must add a black box warning to the professional product label, or “package insert,” for the antidepressant nefazodone (SERZONE), informing doctors and pharmacists that life-threatening liver damage can occur with this drug.

• Supplement to Petition to the FDA to ban the anitidepressant drug nefazadone (SERZONE) (HRG Publication #1681) [hide all summaries]
  We have now updated that analysis to cover the subsequent time period, April 1, 2002 through May 12, 2003. During that period, FDA adverse event data recorded an additional 9 deaths, for a total of 20 reports of death due to liver failure in people using Serzone.
• Petition to the FDA to Ban the Antidepressant Drug Nefazadone (SERZONE) (HRG Publication #1657) [hide all summaries]
  Our own analysis, based on adverse reaction reports to the FDA, revealed that, from 1994, when first marketed, through the first quarter of 2002, nefazodone was associated with at least 53 cases of liver injury including 21 cases of liver failure from which 11 people died.

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