The FDA has issued a warning that cases of life-threatening hepatic failure have been reported in patients using nefazodone hydrochloride (Serzone, Bristol-Myers Squibb, Princeton, NJ), a treatment for depression. Patients taking Serzone should be advised to report signs and symptoms of liver dysfunction such as jaundice, anorexia, or gastrointestinal complaints to their physician immediately. If they develop evidence of hepatocellular injury, such as increased serum aspartate aminotrasferase or serum alanine at levels three times or higher than the upper limit of normal, they should be withdrawn from the drug and should not be considered for re-treatment.
Bernard A. Schwetz, DVM, PhD
Acting Principal Deputy Commissioner
Food and Drug Administration*
In plain English, this means that Serzone has been found to cause liver damage or liver failure. The risk of a patient taking Serzone is 3-4 times as great for liver failure compared to the general population (one out of 250,000-300,000 patients have had it). In the letter to health care providers, Bristol-Myers Squibb Co. also stated that the "rate of liver failure is an underestimate because of under reporting, and the true risk could be greater than this." According to Bristol-Myers Squibb Co., the time it takes for liver failure, causing a need for transplant or death, to occur after starting the drug is 2 weeks to 6 months.
Serzone currently makes $400 million in annual sales but those numbers are expected to decrease. The Canadian government issued a warning in June, 2001 about possible damage that can be done to the liver. Following after Canada, FDA announced on December 7, 2001 that it would require that a black box warning be placed on the drug, which warn patients about life threatening liver damage. (A black-box warning label is the most serious warning issued by the Federal Food and Drug Administration.) Also, Bristol-Myers Squibb Co. issued a manufacturers warning on January 9, 2002 telling United States health care providers that "cases of life threatening hepatic failure have been reported in patients treated with Serzone."
What the drug does:
Serzone is an anti-depressant that is different than other anti-depressants in structure. Serzone is supposed to inhibit serotonin reuptake and blocks one type of serotonin receptor. The drug is normally prescribed to patients that are suffering from depression that causes them to be anxious.
The drug dosage is broken down by color. The red pills are 50mg, the white pills are 100mg, the orange pills are 150mg, the yellow pills are 200mg, and the larger white pills are 250mg. Serious side effects (other than the liver failure) are jaundice (yellowing of your skin or eyes, loss of appetite for a few days or longer, stomach pain, dark urine, or nausea. If any of those things begins to occur, call a doctor immediately.
As if you weren't already convinced, don't take Serzone if you are allergic to Desyrel (trazodone, a related medicine) or are taking:
First hand account:
I was fortunate enough to have taken this drug for a while without my liver failing, thank goodness. The following is my account of what happened when I took the drug, it differs a bit individually, I'm sure, but also there are a few things that seem to be common. After a big move to a different state with only half my family in tact after my parents' divorce, I was more than a bit out of sorts. The response that the therapist had was to put me on Serzone so that I wouldn't have panic attacks due to dysthymia (mild depression, in Greek it means "bad temper" not necessarily of a permanent nature, which I find infinitely amusing). I was started out on a trial run which meant that I had to take 50mg for the first 5 days, then up it to 100mg, and then a while after that I’d go up if needed. The drug took a long time to actually start working. I was up to 100mg before I could feel the effects, which were nice at first and then got to be annoying.
Usually people have a train of thought, which may start off in one place and end up somewhere else. For example, I may have thought "Wow this pizza is good... almost as good as the pizza in New Jersey... I wish I could go back there... it's weird to be in a new place and not know anyone..." and then I may end up feeling a little anxious or sad. Well, that thought progression while on Serzone would go something like this "Wow this pizza is good... almost as good as the pizza in New Jersey.. I wish... what did I wish? lalalalalalala zone out".
Once the level of chemicals in my brain started indicating anxiety, it would feel like I hit a wall and couldn't even think anxious or bad thoughts about anything at all. At first it was like "wow this is cool, I'm mellow all the time". But at the same time, I was never excited or overly happy or able to contemplate anything. Passion is what drives people to make certain decisions, and to be able to assess what they want and what will come out of it. I was passionless for 2 whole months. Eventually the drug would start to wear off and I'd start taking 2 of the 100mg pills to keep a little bit of the calm. After a little while I couldn’t stand it anymore, I started skipping doses and eventually stopped cold turkey.
The doctor who prescribed it to me made a big deal saying how I was supposed to taper down my doses and then stop, but as far as I was concerned it had completely stopped working anyway. I didn't suffer any side effects, as far as I can remember. However, one of my good friends said that I was *extremely* pissy for one day. I stopped taking it when I found out that the therapist had planned on keeping me on the drug for LIFE. I eventually got over the anxiety thing on my own for the most part, barring the occasional worry spree. There are people who may need a drug to keep an out of control brain chemistry in tact, but I really wouldn't suggest that Serzone is the drug to do it.
* Written inquiries may be directed to Office of the Commissioner of Food and Drugs, HF-1, Room 14-71, 5600 Fishers Ln, Rockville, MD 20857.
ascorbic says OK, from what I can see: Serzone is the name in the US and Canada, Dutonin in the UK, and Nefadar in Sweden. I dunno if it's available elsewhere. I'd guess Nefazodone is the best place for yours, despite the Serzone-specific part.
I'm in the process of trying to incorporate this information. Thank you!