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SERZONE: One More Example Of A Cure That Is Not Worth The Risk

Mar 1, 2003 Over the past two years we have written about a number of prescription drugs which have turned out to be extremely hazardous to those who relied upon them for the treatment or cure of various conditions, illnesses, or diseases. We are presently in the process of researching and preparing additional articles on other prescription drugs which pose a significant risk to the public. We believe that one drug in particular, however, should be brought to our readers' attention immediately. That drug is SERZONE.

SERZONE is a powerful antidepressant used to treat a specific form of depression and is available only by prescription. SERZONE is thought to treat depression by correcting an imbalance in the amounts of certain natural chemicals in the brain such as serotonin and norepinephrine. Unfortunately, SERZONE has now been linked to liver failure. According to the manufacturer, the rate of liver failure in SERZONE users is about 3 to 4 times greater than in non-users.

SERZONE is manufactured by Bristol-Myers Squibb ("Squibb") and was approved by the U.S. Food and Drug Administration in December 1994. Annual sales for SERZONE are in the hundreds of millions of dollars. The drug was considered an important alternative to the top-selling class of antidepressants because it was often regarded as less disruptive to sexual activity than Zoloft, Paxil or Prozac.

Psychiatrists in the United States first became concerned with liver failure associated with the use of SERZONE in June 2001 when the Canadian government required Squibb to notify doctors that there had been reports of "109 serious hepatic (liver) adverse events," which "... include 23 cases of liver failure worldwide of which 16 led to transplantation or death. SERZONE has also been temporarily associated with hepatic adverse events such as jaundice, hepatitis and hepatocellar necrosis in patients receiving therapeutic doses".

At the time of the Canadian warning, no similar action was taken in the United States. When Squibb was questioned as to why this warning was being distributed in Canada and not the United States, a company spokesperson, Mary Fury, issued the rather absurd statement that: "We didn't think it was necessary in the U.S. because what happened in Canada happened in Canada."

Finally on December 7, 2001 the FDA told Squibb that it must include a "Black Box" warning on all SERZONE labels. A Black Box warning is the strongest type of warning and is designed to let physicians and patients know of serious side effects associated with a particular drug. The FDA required the warning to advise that patients could suffer from liver failure, leading to death or the need for a liver transplant.

        Black box warning - WARNING

        Cases of life-threatening hepatic failure have been reported in patients treated with SERZONE.

        The reported rate in the United States is about 1 case of liver failure resulting in death or transplant per 250,000 - 300,000 patient-years of SERZONE treatment. The total patient-years is a summation of each patient's duration of exposure expressed in years. For example, 1 patient-year is equal to 2 patients each treated for 6 months, 3 patients each treated for 4 months, etc. (See WARNINGS.)

        Ordinarily, treatment with SERZONE should not be initiated in individuals with active liver disease or with elevated baseline serum transaminases. There is no evidence that pre-existing liver disease increases the likelihood of developing liver failure, however, baseline abnormalities can complicate patient monitoring.

        Patients should be advised to be alert for signs and symptoms of liver dysfunction (jaundice, anorexia, gastrointestinal complaints, malaise, etc.) and to report them to their doctor immediately if they occur.

        SERZONE should be discontinued if clinical signs or symptoms suggest liver failure (see PRECAUTIONS: Information for Patients). Patients who develop evidence of hepatocellular injury such as increased serum AST or serum ALT levels plus or minus 3 times the upper limit of NORMAL, while on SERZONE should be withdrawn from the drug. These patients should be presumed to be at increased risk for liver injury if SERZONE is reintroduced. Accordingly, such patients should not be considered for re-treatment.

Additional details of the risk of liver failure associated with SERZONE are included in a highlighted statement in the warnings section:

        The reported rate in the United States is about 1 case of liver failure resulting in death or transplant per 250,000 - 300,000 patients-years of SERZONE treatment. This represents a rate of about 3-4 times the estimated background rate of liver failure. This rate is an underestimate because of under reporting, and the true risk could be considerably greater than this. A large cohort study of antidepressant users found no cases of liver failure leading to death or transplant among SERZONE users in about 30,000 patient-years of exposure. The spontaneous report data and the cohort study results provide estimates of the upper and lower limits of the risk of liver failure in nefazodone treated patients, but are not capable of providing a precise risk estimate.

Bristol-Myers Squibb was also ordered to issue the same warning in the form of a letter to doctors in the United States. Thomas Laughren, an FDA psychopharmacology team leader, referring to the SERZONE liver failure side effect, stated: "We believe that it is drug related and that this drug is different from others in the class."

In the reported liver failure cases resulting in death or transplant, exposure to SERZONE therapy generally ranged from 2 weeks to 6 months. Although some reports described dark urine and nonspecific prodromal symptoms (e.g., anorexia, malaise, and gastrointestinal symptoms), other reports did not describe the onset of clear prodromal symptoms prior to the onset of jaundice.

The physician may consider the value of liver function testing. Periodic serum transaminase testing has not been proven to prevent serious injury but it is generally believed that early detection of drug-induced hepatic injury along with immediate withdrawal of the suspect drug enhances the likelihood for recovery.

Patients should be advised to be alert for signs and symptoms of liver dysfunction (jaundice, anorexia, gastrointestinal complaints, malaise, etc.) and to report them to their doctor immediately if they occur. Ongoing clinical assessment of patients should govern physician interventions, including diagnostic evaluations and treatment.

SERZONE should be discontinued if clinical signs or symptoms suggest liver failure (see PRECAUTIONS-Information for Patients). Patients who develop evidence of hepatocellular injury such as increased serum AST or serum ALT levels - 3 times the upper limit of normal, while on SERZONE should be withdrawn from the drug. These patients should be presumed to be at increased risk for liver injury if SERZONE is reintroduced. Accordingly, such patients should not be considered for re-treatment.

Because it is difficult to monitor for changes in liver function in patients whose liver function is already abnormal, we direct our readers' attention to the following information contained in CONTRAINDICATIONS:

        SERZONE tablets are contraindicated in patients who were withdrawn from SERZONE because of evidence of liver injury (see Boxed Warning).

        In view of the above changes to the SERZONE labeling, the "Information for Patients" section of the PRECAUTIONS has been expanded to warn patients of the potential risk of hepatotoxicity associated with SERZONE therapy:

        Hepatotoxicity

        Patients should be informed that SERZONE therapy has been associated with liver abnormalities ranging from asymptomatic reversible serum transaminase increases to cases of liver failure resulting in transplant and/or death. At present, there is no way to predict who is likely to develop liver failure. Ordinarily, patients with active liver disease should not be treated with SERZONE. Patients should be advised to be alert for signs of liver dysfunction Jaundice, anorexia, gastrointestinal complaints, malaise, etc.) and to report them to their doctor immediately if they occur.

        Changes consistent with these WARNINGS have been included in a Patient Package Insert that will be provided with the product packaging. For detailed information on approved indications and additional safety information please refer to the SERZONE package insert. A full copy of the current SERZONE Package insert is enclosed.

On January 8, 2002, Bristol-Myers Squibb announced that it would stop selling the antidepressant DUTONIN in Europe. DUTONIN is marketed in the United States as SERZONE. European regulators have expressed concerns over the drug's potentially severe liver effects. The company has continued to sell the drug in the United States even though numerous law suits have been brought.

Dr. Sidney Wolfe, director of the public watchdog organization Public Citizen has stated: "the drug should be off the market." Moreover, as Wolfe points out, published reports of the liver toxicity risks associated with SERZONE date back to at least February 1999, when an article in the Annals of Internal Medicine, a prominent medical journal, reported three cases of liver failure connected with nefazodone, the chemical name for SERZONE.

When taking SERZONE the following symptoms could be indicative that you may be developing a liver problem:

    * yellowing of the skin or whites of the eyes
    * unusually dark urine
    * loss of appetite that lasts several days or longer
    * nausea
    * abdominal pain

The manufacturer has advised people to "call your doctor right away" if you develop any of these symptoms. The manufacturer has further advised that SERZONE should not be used with certain medicines, vitamins, supplements or herbal remedies.

SERZONE patients have brought claims against Bristol-Myers Squibb for damages for:

    * past and future pain and suffering, mental anguish and physical impairment;
    * past and future medical, incidental and hospital expenses; and
    * past and future loss of earning and earning capacity.

If you or a loved one has used SERZONE and has experienced any of the side effects enumerated in this article, contact the law firm of Parker & Waichman immediately for a free consultation and evaluation.

To discuss your experience with SERZONE with others who have taken the drug, click here to visit our SERZONE discussion forum on injurytalk.com.

For further information regarding the rights you or your loved one may have with respect to this matter contact PARKER & WAICHMAN immediately by calling 1-800-YOURLAWYER or visiting http://www.yourlawyer.com.
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