Serzone

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The Big Fat Health and Fitness Lie Craig Pepin-Donat See book keywords and concepts

This recall follows the removal of serzone by Bristol-Myers from the Canadian and European markets on January 8, 2003, because it had been linked to 26 deaths. The drug was yanked off the Canadian and European market in January 2003, but it continued to sell here in the U.S. for another 14 months. The FDA issued a "black box warning" label regarding serzone in 2001, because of a suspected side effect that could cause life-threatening damage to the liver. How about Redux or Fen-Phen?

Generation Rx: How Prescription Drugs are Altering American Lives, Minds, and Bodies Greg Critser See book keywords and concepts

In the case of serzone, an antidepressant approved in 1994 that was flagged early as a severe liver toxin, it took ten years — and eleven U.S. deaths — for withdrawal. No one can quite account for that, given that the drug, which sold upwards of 4.5 million prescriptions a year, was one of the least efficacious antidepressants in that sector's boom market of the 1990s. Even its manufacturer, Bristol-Myers Squibb, claimed that serzone was mainly for people for whom all of the other antidepressants did not work.

Before You Take that Pill: Why the Drug Industry May Be Bad for Your Health J. Douglas Bremner See book keywords and concepts

Given the alternatives of antidepressants that do not cause liver failure and are just as effective, serzone should not be used except as a last resort. Mirtazapine (Remeron) is a quatrocyclic antidepressant that acts on a number of different receptor systems and increases release of norepinephrine and serotonin. Side effects include sweating and shivering, tiredness, strange dreams, elevation of lipids, weight gain, upset stomach, anxiety, and agitation. Mirtazapine works well for depression and is safe.

Generation Rx: How Prescription Drugs are Altering American Lives, Minds, and Bodies Greg Critser See book keywords and concepts

Worse, serzone was a potent liver enzyme inhibitor, which meant that it prevented the liver from processing other drugs properly, leading to further injury from everything from statins to other central nervous system drugs. Yet it was other nations that acted on that information long before the United States did. The Europeans banned serzone in January 2003, and even the Turks took it off the market before Squibb withdrew the drug in the United States in June 2004. It would be wrong, of course, to say that neither the FDA nor the industry cares about patient safety.

Even its manufacturer, Bristol-Myers Squibb, claimed that serzone was mainly for people for whom all of the other antidepressants did not work. Yet its hepatotoxicity was clear, and reports during the years immediately after its release, both at the FDA and at Squibb, indicated that people were suffering from it. Worse, serzone was a potent liver enzyme inhibitor, which meant that it prevented the liver from processing other drugs properly, leading to further injury from everything from statins to other central nervous system drugs.

Psyched Out: How Psychiatry Sells Mental Illness and Pushes Pills That Kill Kelly Patricia O'Meara See book keywords and concepts

STAGE 5: Combination Therapy: The physician may prescribe a tricyclic antidepressant with an SSRI or choose the following combinations thatmustbe taken simultaneously including, Wellbutrin plus an SSRI, or serzone with a SSRI, or Wellbutrin with serzone. STAGE 6: ECT: (Electroconvulsive Therapy "Electric Shock"): If patient refuses ECT or does not respond, go to next stage or repeat an earlier stage with a different agent (drug). STAGE 7: Other: Any antidepressant or combination not previously tried.

America Fooled: The Truth About Antidepressants, Antipsychotics and How We've Been Deceived Dr. Timothy Scott See book keywords and concepts

The Bristol-Myers Squibb antidepressant serzone (nefazodone) was first made available to both U.S. and Canadian citizens in 1994. Numerous drugs that have been approved for use by the FDA were later found to cause liver damage. (All drugs are, in one sense, poisons. It is the liver's job to filter out and break down any "poison" such as alcohol and illegal or legal drugs. Hence, regular intake of any of these has the potential to harm the liver and to a lesser extent, the kidneys, the body's other filter.) But the warnings about serzone were particularly clear.

The Dutch Medicines Evaluation Board (CBG) announced in 2002 that because of the danger of liver failure serzone was going to be removed from the Dutch market.20 Other European countries followed suit, but the FDA never removed serzone from the U.S. market. However, the antidepressant could not withstand the media reports which decimated sales and increased lawsuits. The company claimed their decision to remove their drug was due to declining sales, not safety concerns.

Comfortably Numb: How Psychiatry Is Medicating a Nation Charles Barber See book keywords and concepts

Arif Khan, a psychiatrist and researcher in Washington state, used the Freedom of Information Act to obtain the FDA clinical trial database for antidepressant drugs, which included Prozac, Zoloft, Paxil, serzone, Remeron, Wellbutrin, and Effexor. Khan examined 45 trials, involving about 9,000 patients, and found there was an average symptom reduction of 44 and 48 percent in patients treated with the drugs, and 36 percent with patients treated with placebo after eight weeks of treatment. At the end of the day, an unimpressive difference, unworthy of the hype.

The little pills, which could be any one of thirty available drugs used as antidepressants—Prozac or Zoloft or Paxil or Celexa or Lexapro or Luvox or BuSpar or Nardil or Elavil or Sinequan or Pamelor or serzone or Desyrel or Norpramin or Tofranil or Adapin or Vivactil or Ludiomil or Endep or Parnate or Remeron—make a slight, not unpleasant flutter as they pass down her throat. Julie examines her face in the mirror and sighs. She tightens the cap, places the bottle back in the cabinet, puts the glass by the sink, and thinks abstracdy of the pills settling in her stomach.

The Big Fat Health and Fitness Lie Craig Pepin-Donat See book keywords and concepts

The FDA issued a "black box warning" label regarding serzone in 2001, because of a suspected side effect that could cause life-threatening damage to the liver. How about Redux or Fen-Phen? Doctors reported an increase in heart valve failure resulting from the key ingredients of dexfenflu-ramine and fenfluramine in these "miracle diet drugs." Prior to its recall in 1997, the dream drug Fen-Phen turned into a nightmare for the 6 million people who had been using it and suddenly, had to worry about the damage that it had done to their hearts. Merck & Co., Inc.

Psyched Out: How Psychiatry Sells Mental Illness and Pushes Pills That Kill Kelly Patricia O'Meara See book keywords and concepts

STAGE 5: Combination Therapy: The physician may prescribe a tricyclic antidepressant with an SSRI or choose the following combinations thatmustbe taken simultaneously including, Wellbutrin plus an SSRI, or serzone with a SSRI, or Wellbutrin with serzone. STAGE 6: ECT: (Electroconvulsive Therapy "Electric Shock"): If patient refuses ECT or does not respond, go to next stage or repeat an earlier stage with a different agent (drug). STAGE 7: Other: Any antidepressant or combination not previously tried.

Critical Condition: How Health Care in America Became Big Business Donald L. Barlett and James B. Steele See book keywords and concepts

In July 2001, Health Canada, the FDA's Canadian counterpart, issued a warning about the antidepressant nefazodone, marketed under the trade name serzone by the Bristol-Myers Squibb Company. Health Canada said the drug was causing liver damage that "resulted in hospitalization, liver transplantation, or death." It took the FDA another six months to come to the same conclusion and issue an order requiring a similar warning when the drug was prescribed in the United States. It stated in part: "Cases of life-threatening hepatic failure have been reported in patients treated with serzone . . .

Generation Rx: How Prescription Drugs are Altering American Lives, Minds, and Bodies Greg Critser See book keywords and concepts

The Europeans banned serzone in January 2003, and even the Turks took it off the market before Squibb withdrew the drug in the United States in June 2004. It would be wrong, of course, to say that neither the FDA nor the industry cares about patient safety. Billions are spent yearly in its service and improvement, and there are thousands of talented, impassioned individuals, many of them driven by professional and social ideals, in search of better patient safety.

Best Choices From the People's Pharmacy Joe Graedon, M.S. and Teresa Graedon, Ph.D. See book keywords and concepts

Sudden discontinuation of drugs like Effexor, Paxil, serzone, and Zoloft may cause unexpected symptoms. We have heard from many patients that they experienced dizziness, nausea, insomnia, headaches, nervousness, sweating, shakiness (like a bad hangover), weakness, visual disturbances, and an inability Watch Out for Withdrawal! I take Zoloft, and have tried to stop taking it several times. Each time I stop I experience a very strange thing. Doctors, nurses, and pharmacists dismiss me like I'm a nut case, but I swear this is true.

Psyched Out: How Psychiatry Sells Mental Illness and Pushes Pills That Kill Kelly Patricia O'Meara See book keywords and concepts

The stages are as follows: STAGE 1: Monotherapy (single drug): the physician may choose one mind-altering drug from the approved SSRIs (Prozac, Paxil, Zoloft or Celexa), or prescribe another antidepressant not specifically a SSRI, such as Wellbutrin, serzone, Effexor or Remeron. STAGE 2: Monotherapy (single drug): the physician may choose any one of the mind-altering drugs listed in Stage 1 or may choose a tricyclic antidepressant (TCA) such as Tofranil, Anafranil, Norpramin, Pamelor or Elavil (all of which are also sedatives).

Critical Condition: How Health Care in America Became Big Business Donald L. Barlett and James B. Steele See book keywords and concepts

Wolfe, continued to press the case against serzone by filing a supplement to its original petition to ban the drug. "We found almost as many deaths from liver failure reported in the last fourteen months we examined as in the seven previous years (nine vs. eleven)," Public Citizen said. The FDA would not be stampeded. The agency so obsessed with products coming out of Canadian pharmacies was more tolerant of a domestic drug company. It allowed Bristol-Myers to keep serzone on the U.S.

Psyched Out: How Psychiatry Sells Mental Illness and Pushes Pills That Kill Kelly Patricia O'Meara See book keywords and concepts

The patented mental health drugs embedded within this model program include: Risperdal, Zyprexa, Seroquel, Geodone, Depakote, Paxil, Zoloft, Celexa, Wellbutrin, Zyban, Remeron, serzone, Effexor, BuSpar, Adderall and Prozac, all manufactured by the above companies. 8. TMAP concluded that the atypical antipsychotic medications Risperdal, produced by Janssen Pharmaceutica, Zyprexa produced by Eli Lilly, and Seroquel, produced by AstraZeneca, are the drugs of choice for all first, second and third-line treatments for Schizophrenia. 9.

Critical Condition: How Health Care in America Became Big Business Donald L. Barlett and James B. Steele See book keywords and concepts

After meetings with regulators, Bristol-Myers agreed to pull serzone from the Canadian market. The reason: Now there were fifty-one reports of Canadian patients who suffered liver damage while taking the drug. Two patients had to undergo liver transplants. One died. Back in the States, Public Citizen Health Research Group, a leading consumer organization headed by Dr. Sidney M. Wolfe, continued to press the case against serzone by filing a supplement to its original petition to ban the drug.

Selling Sickness: How the World's Biggest Pharmaceutical Companies Are Turning Us All into Patients Ray Moynihan and Alan Cassels See book keywords and concepts

Those educational seminars were in fact part of a much bigger project attempting to raise awareness among Australian doctors and the public about depression, funded in part by Bristol-Myers Squibb, the makers of an antidepressant called serzone. Funding also came from state and federal governments. In turn, this project was just one of many similar programs to "educate" doctors, funded generously by the makers of the other antidepressants throughout the 1990s. The programs reaped major benefits for their private sponsors.

America Fooled: The Truth About Antidepressants, Antipsychotics and How We've Been Deceived Dr. Timothy Scott See book keywords and concepts

Yet, if it were not for the Freedom of Information Act, no one would imagine that even the drug studies responsible for Prozac, Zoloft, Paxil, Effexor, serzone and Celexa receiving FDA approval found these drugs work only slightly better than a placebo. It is clear why this research team from the University of Connecticut and the George Washington University School of Public Health and Health Services chose to entitle their study, "The Emperor's New Drugs." patient would remit," the drugs should be prescribed.

However the drug went off patent in 2003, and the steep price drop which that event always triggers combined with headlines such as "Teen death stirs fresh debate about depression medication; Bristol-Myer's serzone, despite removal elsewhere, is still available in the U.S." made the profit-lawsuit risk equation very unattractive.22 (3) The Redux debacle is perhaps our nation's best known example of a drug being approved by the FDA and then later having to be recalled. Redux was the first half of the famous combination of two diet pills, Redux (dexfenfluramine) and Phentermine—hence, fen-phen.

They wanted to see the data the drug companies submitted for gaining FDA approval for the six antidepressants which were most widely prescribed between 1987 and 1999—Prozac, Paxil, Zoloft, Effexor, serzone, and Celexa. The FDA released to the researchers the data for the 47 clinical trials used for gaining approval for the six antidepressants. From this information at least five facts were learned that I believe would greatly surprise most Americans and most physicians.

Trick Eight: Use Invalid Measures of Success A study of the antidepressant serzone (nefazodone) which appeared in the New England Journal of Medicine used as poor a research design as I have ever seen.21 Yet appearing in the New England Journal of Medicine silently implies the research must be of high quality. Perhaps that is why it has been termed a "landmark study"22 and has been often cited.23 The study began with 681 patients who had a history of depression.

Psyched Out: How Psychiatry Sells Mental Illness and Pushes Pills That Kill Kelly Patricia O'Meara See book keywords and concepts

The drugs recommended for the warning are the 10 most widely used: Prozac; Zoloft; Paxil; Luvox; Celexa; Lexapro; Wellbutrin; Effexor; Serzone; and Remeron, as well as an additional 24 antidepressants.

Critical Condition: How Health Care in America Became Big Business Donald L. Barlett and James B. Steele See book keywords and concepts

In any case, with sales falling and the number of lawsuits by consumers claiming they were harmed by the drug rising, Bristol-Myers quietly removed serzone from the U.S. market in June 2004. Does it make any difference if Canadian authorities issue drug warnings before the FDA? It certainly did in the case of the drug Cor-darone. Just ask Kenneth Krutz of Chicago, who in 1988 retired after more than four decades from his job as a plant superintendent at Acra Electric Corporation, a manufacturer of custom heating elements in Schiller Park, Illinois.

The Truth About the Drug Companies: How They Deceive Us and What to Do About It Marcia Angell, M.D. See book keywords and concepts

Using the Freedom of Information Act (a law that allows citizens to obtain government documents), the authors obtained FDA reviews of every placebo-controlled clinical trial submitted for initial approval of the six most widely used antidepressant drugs approved between 1987 and 1999—Prozac, Paxil, Zoloft, Celexa, serzone, and Effexor (all but the last two are SSRIs).23 As is typical, most of the forty-two clinical trials lasted for just six weeks. Their findings were sobering. On average, placebos were 80 percent as effective as the drugs.

Ultraprevention : The 6-Week Plan That Will Make You Healthy for Life Mark Hyman, M.D. See book keywords and concepts

His doctor immediately recommended a new antidepressant called serzone. The man refused it, pointing out that you're supposed to be nervous when you get married, take a new job, and move to a new country. But doctors want to medicate you simply for living your life. Rather than do that, we are attempting to help the body do what it does normally, but do it better, which is why we have been promoting the use of what we call pro-drugs. Rather than fight against the natural processes of your body, a pro-drug works with your body to make it healthier.

Disease Prevention and Treatment The Life Extension Editorial Staff See book keywords and concepts

Zoloft is recommended at 50 mg, but 25 mg works well for many mild depressions. serzone is recommended at 100 mg twice-daily, but 50 mg once or twice daily is usually plenty initially. Similar strategies apply to Paxil, Wellbutrin, Celexa, Norpramin, Pamelor, imipramine, doxepin and just Table 2: Low'Dose Prozac Studies before and shortly after Prozac's approval revealed that 5 mg-and less toxic for many people. J. Clin. Psychopharmacol (Schatzberg et al. 1987) Psychopharmacol. Bull. (Wernicke et al. 1988) J Clin. Psychiatry (Salzman 1990) ] Clin. Psychiatry (Schatzberg 1991) ] Clin.

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