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Since they arrived on the market in the 1990s, the so-called 'atypicial' antipsychotic drugs have been wrapped in controversy and promotional hype by drug companies and their paid professional spin masters who made bald claims about their "favorable side effect profile" referring to them as "breakthrough" "miracle" drugs that "balance the chemistry" in the brain.
In his book, Mad in America, Robert Whitaker relied on data available to the FDA but not made known to most doctors who prescribe these drugs or to patients and families. In clinical trials prior to FDA approval: "One in every 145 patients who entered the trials --for risperidone, olanzapine, quetiapine, and a fourth atypical called sertindole--died, and yet those deaths were never mentioned in the scientific literature." (p. 269)
It can be said, therefore, that contrary to what psychiatrists have been telling patients and their families, the drugs prescribed for schizophrenia have severe undesirable side effects. For some individuals, the side effects are fatal.
On July 1, 2002, Duke University issued a Press Release about the most recent finding that links the new anti-psychotics to early onset diabetes. The team of researchers--Elizabeth A. Koller, M.D. from the FDA, and Murali Doraiswamy, M.D. from Duke-- analyzed FDA's adverse drug report database, MedWatch (which receives 10% of adverse drug reports). They identified 289 cases of diabetes in patients who had been prescribed olanzapine (a.k.a. Zyprexa), Eli Lilly's most profitable drug.
The researchers reported: "Of the 289 cases of diabetes linked to the use of olanzapine, 225 were newly diagnosed cases. One hundred patients developed ketosis (a serious complication of diabetes), and 22 people developed pancreatitis, or inflammation of the pancreas, which is a life-threatening condition. There were 23 deaths, including that of a 15-year-old adolescent who died of necrotizing pancreatitis, a condition where the pancreas breaks down and dies. Most cases (71 percent) occurred within six months of starting the drug and many cases were associated with moderate weight gain."
The evidence from pre-marketing trials was also alarming: Whitaker wrote: "Of the 2,500 patients in the trials who received olanzapine, twenty died. Twelve killed themselves...Twenty-two percent [ ] suffered a 'serious' adverse event, compared to 18 percent of the haloperidol patients. Two-thirds of the olanzapine patients didn't successfully complete the trials...."(p. 281)
According to the Duke researchers, many cases of diabetes have also been reported with other antipsychotic drugs. In 1994, a Duke team first reported a Diabetes link to the first 'atypical' antipsychotic drug, clozapine: last year, 384 reports of diabetes last year were associated with clozapine.
Whereas the British Medical Control Agency and the Japanese Health & Welfare Ministry have issued warnings about the risk of diabetes for patients prescribed Zyprexa, FDA has remained silent.
It is astounding to AHRP that the FDA has approved a clinical trial that exposes teenagers-- who are not even diagnosed with schizophrenia-- to a drug that puts them at risk of diabetes. The trial is being conducted at Yale University.
[See, AHRP complaint filed with the federal Office of Human Research Protection at: http://www.researchprotection.org/Initiatives/YaleComplaint.html]
Psychopharmacology TIDBITS
Ann M. Hamer, PharmD
April 29, 2002
Zyprexa, Weight Gain and Diabetes.
Zyprexa has been linked to two more deaths raising the total to 36 worldwide. The Japanese government issued a warning over the use of the drug after the two deaths occurred. The Health, Labor and Welfare Ministry said diabetes patients should not be treated with the drug and all patients should be examined for possible abnormal levels of blood sugar.
What are the facts? There are typically thought to be 5 modifiable risk factors for cardiovascular disease including: obesity, dyslipidemia, glucose intolerance, hypertension and smoking. Epidemiologically, schizophrenic patients are more likely to be obese (BMI >27=42% vs. 27% in general population), smoke (50-80% of patients smoke vs. 25% in general population) and have problems with glucose regulation (double the risk of developing type 2 diabetes relative to the general population). Atypical antipsychotics compound the problem by commonly causing excessive weight gain, hyperlipidemia and glucose intolerance. The interrelationship between atypical antipsychotics, obesity and diabetes has become an increasing concern.
On average, patients taking Zyprexa gain 12 kilograms (24-25 pounds) in the first year of therapy. A 1999 article in the European Heart Journal reported that a 10% weight gain past the age of 20 years increased the risk of cardiovascular disease by 50%. A similar weight gain in patients who smoke increased the chance of cardiovascular disease by 300%. In addition, Zyprexa has been linked to hypercholesterolemia.
The effect of atypicals on glucose regulation is an even greater concern. Again, schizophrenic patients, independent of atypical antipsychotic use, are twice as likely as the general population to develop diabetes. Further, atypical agents cause weight gain and can alter insulin sensitivity and glucose regulation. The estimated rate of diabetes with Zyprexa is 6-11%. Case reports of diabetic ketoacidosis, diabetic coma and death have been reported. Owing to the need for long-term medication maintenance, assessment of cardiovascular/diabetes risk status is indicated prior to the start of atypical antipsychotics. Baseline blood glucose and lipid profiles are important. It is further recommended that patients have follow-up monitoring semi-annually. Worsening lipid profiles should be treated and dietary and smoking cessation counseling may be of benefit.
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