Public Citizen, a consumer advocacy group, has petitioned the U.S. Food and Drug Administration (FDA) to remove the antidepressant nefazodone from the market because it has been linked to at least 11 deaths in the United States from liver toxicity and has no unique benefits.
The drug, manufactured by Bristol-Myers Squibb and marketed under the name Serzone, was removed from the European market in January 2003 after the Swedish Medical Products Agency said it would require the drug’s label to contain a warning for potential liver toxicity.
In 2001, there were more than 4.5 million prescriptions for Serzone filled in the United States.
According to reports, nefazodone was associated with at lease 53 cases of liver injury, including 21 cases of liver failure and 11 deaths, from 1994 to 2002. The manufacturer acknowledges 28 reports of liver failure, including 18 deaths, worldwide.
Researchers say the drug is no more effective at treating depression than other drugs, yet displays more dangers. In one analysis of 13 antidepressants, nefazodone had the highest incidence of liver injury, with rates seven to 22 times higher than those of the other antidepressants.
Nefazodone inhibits a key enzyme that is involved in the detoxification of many prescription drugs, which increases the dangers of toxicity from other drugs a patients is taking at the same time. Additionally, nefazodone can become more concentrated and potentially toxic itself when this enzyme is inhibited.
The FDA required that Bristol-Myers Squibb add a "black box" warning to the drug’s insert in December 2001 warning of life-threatening liver damage and suggesting that physicians tell patients to look out for signs of liver problems.
The warning also recommends monitoring of patients’ liver function, although another notice on the drug’s label reportedly downplays the tests’ necessity.
Due to the potential for liver toxicity, the consumer group recommends that anyone taking nefazodone consider switching to a different antidepressant.
Public Citizen March 6, 2003
The tragic aspect of this scenario is that those who are depressed may be suffering due to a nutritional component.
Soda, juices, sugar-coated grain cereals, candies, cookies, doughnuts, chips, popcorn, ice cream, pizza and vegetables oils are loaded with trans omega-6 fats along with a deficiency of omega-3 oils. The amazing thing is that so many people actually survive this nutritional assault.
Certainly, emotional factors are also major contributors to depression, and an optimum diet may not resolve depression in many children. However, that is in no way a carte blanche justification to use mind-altering drugs to treat the symptoms.
Use of these drugs is especially concerning since recent studies prove that antidepressants don’t work much better than sugar pills (placebos).
If you are concerned about depression in yourself or your child, please review the recent guidelines I compiled on how to treat depression.
If your child has depression, why not use a simple, safe and inexpensive technique that has a high likelihood of addressing the cause of the depression rather than just covering up the symptoms with a drug Band-Aid?
Energetic rebalancing techniques work to resolve the cause behind the depression. One such technique, my favorite, is the Emotional Freedom Technique (EFT). You can review my free, 25-page report that discusses how to perform the EFT technique, however, depression is best treated with a trained EFT therapist. To find an EFT therapist, you can review Gary Craig's EFT Practitioner Referrals.
Please also consider optimizing your child’s diet by eliminating all of the sugar and most all grain products. You can also review the comprehensive nutrition plan for further information.
One of the most important tools in optimizing your own or your child’s diet is to make sure you are getting enough omega-3 fats. An excellent source of these fats are cod liver oil and fish oil. I have had large numbers of patients spontaneously take themselves off their antidepressants once they started the fish oils.
Dr. Stoll, director of the psychopharmacology research lab at Boston's McLean Hospital and assistant professor of psychiatry at Harvard Medical School, discusses this topic extensively in his book The Omega-3 Connection. I highly recommend this book, which reviews new evidence supporting the use of omega-3 oils for depression.
I also recommend finding a high-quality source of fish oil. It is necessary to have a quality source to ensure that toxins and other impurities have been removed from the oil. I offer Carlson’s brand fish oil and cod liver oil on this site, as I have found it to be of superior quality.
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