Serzone

Approved in 1994 by the US Food and Drug Administration (FDA) as an aid for the treatment of severe depression, Serzone has also been prescribed for the treatment of chronic fatigue, eating disorders, irritable bowel syndrome, fibromyalgia, and Lupus. Serzone is also used to treat arthritis, bipolar depression, anxiety, and panic.

Also known by the generic name of nefazodone hydrochloride, the drug was commonly administered to people who suffer from slowed thinking, difficulty concentrating, changes in sleep habits, and suicidal thoughts, as well as feelings of worthlessness, guilt, stress, increased fatigue, and lack of mind and body coordination.

Bristol-Myers Squibb, responsible for the manufacturing of this drug, announced the withdrawal of Serzone on May 20, 2004, after unsuccessful attempts made by the Public Citizen, who sued the FDA to force the banning of the drug. The American consumer advocacy group was one of the first citing the potential deadly liver complications linked to this antidepressant.

Common side effects of Serzone included confusion, dizziness, abnormal or blurred vision, constipation, dry mouth, nausea, sleepiness, light-headedness, and weakness. When injuries became severe, patients experience cough, decreased concentration, abnormal dreams, and flu-like symptoms, including dizziness and headache.

Major problem were associated to abnormal bleeding, chest pain, breast enlargement in males, breast-milk discharge in women, difficulty urinating, and life-threatening liver damage, the main lawsuit claim. However, the withdrawal was announced as a result of Serzone's poor sales worldwide rather than those potential health risks associated with the drug.

In December 2001, the FDA issued a warning for Serzone labels alerting liver damage complications. Dozens of deaths resulting from the use of Serzone were reported and lawsuits filed by family members, claiming compensation for those deaths. Only in the United States, about 7 million people have taken Serzone, increasing the chances for more lawsuits to be filed.

The total number of patients worldwide is estimated around 8.3 million people, meaning that Bristol-Meyers's favorite victims were American citizens. By the time of the withdrawal, Robert Hutchinson, a spokesman for Bristol-Myers Squibb said, "we'll continue to vigorously defend itself against the implication that Serzone is unsafe".

After the introduction of Serzone in North America, The Medical Letter, a non-profit publication, said that "Available data are inadequate to determine how nefazodone compares with other antidepressants. Better-established drugs are preferred." Class action lawsuits has been filed against Bristol-Myers Squibb, but includes other manufactures of the generic versions of Serzone called simply nefazodone.

Serzone victims are encouraged to protect their rights, finding a lawyer to file their class action lawsuit on their own or on behalf of people who passed away after being prescribed with this drug. Some studies also revealed that antidepressants of this type increase the risk of suicidal thinking and behavior in children and adolescents with Major Depressive Disorders.

If your children or adolescent was prescribed with Serzone, you must observe for suicidal tendencies, clinical worsening, or unusual changes in behavior, before it is too late. Even when Serzone was pulled out the markets, the side effects can remain for years.