When Zyprexa was approved to treat adults with schizophrenia in 1996, Eli Lilly and the FDA knew about drug's lethal side effects. Data from a 1996 six-week clinical trial reveals 27 deaths, 15 of which were suicides, and a drop-out rate of 65%.
In his book, Mad In America, investigative journalist Robert Whitaker, reported that one in every 145 subjects who entered the clinical trials for Zyprexa, Risperdal, Seroquel, and Serdolect had died.
FDA data obtained by Bob Whitaker, under the Freedom of Information Act, the year Zyprexa was approved, reveals adverse effects to include: cardiac abnormalities and hypotension in 10% to 15% of the patients; acute weight gain in 50% of the patients; Parkinson-like motor impairment in 11.7%; and unbearable restlessness (akathisia) in 7.3% of the patients.
Two years after Zyprexa was approved, a series titled "Doing Harm: Research on the mentally ill," by Bob Whitaker, was published on the front page of the Boston Globe, on Nov 15-18, 1998, and reported that in pre-marketing clinical trials, Zyprexa was linked to life-threatening adverse effects in 22% of the adult patients tested.
Since its approval, Zyprexa has been exposed as responsible for a high incidence of stroke, diabetes, endocrine, cardiac problems and movement disorders. And yet, the drug has been routinely prescribed to adults of all ages and to children, despite the fact that the FDA has not approved Zyprexa for pediatric use.
In July 2002 issue of Pharmacotherapy, P Murali Doraiswamy, the chief of biological psychiatry at Duke University, published a review of adverse events reported to the FDA by Zyprexa patients that found 289 cases of diabetes, 100 patients with ketosis (a serious complication of diabetes), and 22 cases of pancreatitis, a life-threatening condition. The review documented 23 deaths, including a 15-year-old adolescent who died of necrotizing pancreatitis.
In February 2004, the American Diabetes Association, the American Psychiatric Association, the American Association of Clinical Endocrinologists and the North American Association for the Study of Obesity issued a joint statement confirming the association between diabetes and Zyprexa.
That same month, independent researcher, Dr David Healy, after studying the FDA's raw data on Zyprexa, told the New York Times that Zyprexa was among "the deadliest drugs ever to gain FDA approval".
In October 2005, the Journal of the American Medical Association published a meta-analysis of 15 randomized trials of more than 5,000 elderly patients treated with atypical antipsychotics which found patients taking the drugs had a 54% increased chance of dying within 3 months, compared with patients taking a placebo.
While the FDA allowed Lilly to subject patients to the risks associated with the drug, a recent study published in the September 2005 New England Journal of Medicine, found that although Zyprexa was the most expensive and most prescribed antipsychotic, it was only slightly more effective than the cheaper 40-year-old generic drug, Perphenazine.
In addition, the study determined that patients on Zyprexa reported more side effects than those taking the generic or one of the other antipsychotic drugs.
Sales of Zyprexa, dwindled in the last quarter of 2005, as news of the drug's lethal side effects made headlines. In June 2005, word got out that Lilly had agreed to pay $690 million to settle a lawsuit filed on behalf of about 8000 Zyprexa patients who alleged they had not been warned of the drug's increased risk of diabetes.
Ellen Liversridge was one of the litigants in the class action lawsuit. Ellen's 30-year-old son, Rob, died due to the adverse effects of Zyprexa.
"Rob gained almost 100 pounds on Zyprexa," Ellen reports, "back before there was a warning on the label."
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