Zyprexa Lawsuits - Eli Lilly May Lose Insurance Coverage

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By Evelyn Pringle (about the author) Page 5 of 6 page(s)

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The most severe threat to the market, the report says, is the risk of therapeutic substitution with generic risperidone, when the drug loses patent protection in 2008 in the US, in 2007 in Europe, and 2006 in Japan.

"The launch of generic risperidone will affect the sales of all branded atypical antipsychotics -- both those currently on the market and emerging drugs," said Kate Hohenberg, director at Decision Resources.

"Although this trend did not happen in the antidepressant arena following Prozac's patent expiration," she explained in the press release, "it will happen with risperidone because of the relatively high cost of antipsychotics and the growing reimbursement constraints in all regions -- even in the lucrative U.S. market."

While the public health agencies in Japan and the UK issued Zyprexa warnings about the increased risk of diabetes in 2002, the FDA waited until September 2003, to make Lilly add a warning.

Ironically, Lilly's second best selling product line in 2003 was diabetes drugs, including Actos, Humulin, and Humalog, which together had sales of $2.51 billion in 2003.

According to Ellen Liversridge, a plaintiff in the class action that was settled in June 2005, who's 39-year-old son died as a result of taking Zyprexa, "both the FDA and Lilly fought putting a warning on the label, but thorough articles on the front pages of the Baltimore Sun, Wall St. Journal, and new York Times so embarrassed the FDA that they finally gave in to warnings."

"The FDA required the same warning on all atypical labels," Ellen notes, "even though Zyprexa was associated with a 37% increase in the risk of diabetes as compared to other atypical anti-psychotic medications."

"After the settlement in June 2005," she says, "they continued to deny the ill effects of Zyprexa, and only mentioned diabetes, not hyperglycemia or death."

In addition to diabetes, the new antipsychotics have been linked to numerous other serious health problems. In a recent analysis, the FDA found that elderly patients using Zyprexa had "a higher chance for death than patients who did not take the medicine."

According to Dr Louis Caplan, MD, Professor of Neurology at Harvard Medical School, the overuse and abuse of antipsychotics may cause the death and morbidity of patients who have been admitted to a hospital for an acute illness.

"These drugs used to control agitation," he said, "are often given in high doses to very sick patients in intensive care units or on medical and surgical units," in the February 21, 2006, journal Neurology, Volume 6 p 4.

"Agitation is not a disease;" he explains, "it is a symptom of complex medical and neurological problems."

"Unfortunately," he notes, "the antipsychotics cause oversedation that impairs speech and other interactions making it difficult to take a history or perform the neurological examination."

"They make patients feel wooden," Dr Caplan advises, "and grossly diminish activity and communication skills."

When patients rebound and become more alert they naturally become agitated and then they are knocked down again, he says, and it may take weeks and months for the CNS effects to wear off.

"Originally," he points out, "these antipsychotics were used for young schizophrenic patients."

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