Zyprexa®

Representing the injured, the wronged and their families

Do not discontinue taking any medications without first consulting your physician.

Zyprexa Dangers
Zyprexa, or olanzapine, is an atypical antipsychotic medication that is Eli  Lilly’s best selling drug. The Food and Drug Administration (FDA)  approved the drug for the short-term treatment of schizophrenia in  September 1996, and it has since been approved for the long-term  treatment of schizophrenia and for treatment in various forms for  bipolar disorder. Zyprexa has also been prescribed for “off-label” uses  not approved by the FDA including insomnia, anxiety, dementia, ADD, and  a variety of behavioral issues.

Recently questions have arisen  concerning the safety of Zyprexa in light of several studies and  reports that suggest a link between Zyprexa—and other atypical  antipsychotic drugs—and high blood sugar, diabetes, and serious diabetic complications.

What are the risks?
The manufacturer reminds us on Zyprexa’s Web site, “Many  years of scientific studies and clinical experience have demonstrated that  Zyprexa is an effective and generally well-tolerated antipsychotic medication  for people suffering from schizophrenia or bipolar disorder.”

The FDA’s Patient Information Sheet for Zyprexa lists the following potential side effects:

• Low blood pressure seen as dizziness and possible fainting
• Increased heart beat
• Seizures
• Liver Problems

The FDA also lists the following possible conditions and  risks of Zyprexa therapy:

• High blood sugar and diabetes
• A life-threatening nervous system problem called neuroleptic malignant syndrome
• A movement problem called tardive dyskinesia
• Stroke
• Increased chance of death in elderly persons treated for dementia (although Zyprexa is not approved for this use)

What do the experts say?
A  research team including a Duke University Medical Center physician and  FDA medical officers discovered a possible link between Zyprexa and  diabetes. In the November 28, 2001 issue of theJournal of the American Medical Association(1),  the researchers submitted a letter suggesting a link between the use of  Zyprexa in adolescents and incidents of hyperglycemia. In their  research they cited nine instances of hyperglycemia in 13-18 year-olds  reported to the FDA, all of which appeared in less than six months. One  subject died from pancreatitis.

Later the group reported additional information in a study published in the July 2, 2002 issue of Pharmacotherapy (2) where their research found a link between the use of atypical  antipsychotics, especially Zyprexa, and cases of diabetes and  hyperglycemia and related complications. Upon further examination of FDA reports concerning Zyprexa they discovered that 289 patients  developed diabetes, 100 patients developed ketosis, and 22 developed pancreatitis. Twenty-three people died. The evidence from the  pre-marketing trials was also distressing: 20 patients of 2,500 died.

In  light of this information several physicians have expressed the  sentiment that though Zyprexa and drugs like it have proven benefits,  stricter labeling should warn doctors about diabetes-related  complications in the patients prescribed Zyprexa.

Eli Lilly  continues to maintain that the drug is safe and that if any  diabetes-related side effects are problematic, it’s the fault of  atypical antipsychotics as a whole, not just Zyprexa. The company also  contends that the benefits outweigh the risks for this drug.

What is being done to protect consumers?
Both  the Japanese and the British governments have issued warnings to be  displayed prominently on the labeling of Zyprexa alerting patients to  the diabetes and hyperglycemia risks associated with Zyprexa use after  receiving a troubling number of reports of serious hyperglycemia,  diabetes, ketoacidosis, coma, and death in Zyprexa users.

In  September 2003, the FDA required that atypical antipsychotic drugs,  including Eli Lilly’s Zyprexa, should include updated labeling that  informs users of the suggested link between these drugs and the risk  for diabetes and hyperglycemia (4). The requested labeling also  suggests that diabetics and those patients with diabetic risk factors  be tested for blood sugar abnormalities. The FDA was spurred to action  by the increasing numbers of epidemiological studies that link atypical  antipsychotic use to an increase in hyperglycemia-related adverse  events. On March 1, 2004, Eli Lilly announced in a letter to healthcare  professionals their intention to comply with these labeling suggestions  (5).

In April 2005 the FDA urged Eli Lilly to revise the warning  label on Zyprexa to include a warning that older patients treated with  atypical antipsychotics for dementia had a higher chance for death than  patients who did not take the medicine (6).

What should I do if I am taking Zyprexa?

You  should never discontinue any medication without first consulting a  physician. However, if you are taking Zyprexa, you should be aware that  there might be a link between the drug and abnormal glucose levels. You  should also be aware of the other side effects and warning signs listed  above and consult a physician immediately if you notice anything out of  the ordinary.

If you or someone you love has experienced one or  more of the serious side effects listed above while taking Zyprexa,  contact our law firm today.

Sources:

1. Journal of the American Medical Association, Vol. 286, No. 20, 11/28/01.
   
   
2. Pharmacotherapy, Vol. 22, No. 7, 7/2/02.
   
   
3. 2004 Safety Alert: Zyprexa from www.fda.govaccessed on 10/18/05.
   
   
4. FDA Orders New Warning on Atypical Antipsychotics from Psychiatric News, May 6, 2005 accessed on 10/18/05.
   
   
5. “Drug Debate: New Antipsychotics Pose a Quandary for FDA, Doctors,” Wall Street Journal, 4/11/03.
   
   
6. “Studies link Zyprexa to diabetes deaths,” the Baltimore Sun, 3/19/03.
   

Do not discontinue taking any medications without first consulting your physician.

This  article is for informational purposes only. It is not intended to  constitute medical advice and should not be viewed as such. For medical  advice, you should always consult with your physician.

Zyprexa®  is a registered trademark of Eli Lilly and Company and is used here  only for the purpose of identifying the product in question.

Our law firm is not affiliated with, sponsored by, or associated with any of the following:

• Eli Lilly and Company
• FDA
• Duke University Medical Center
• JAMA
• Pharmacotherapy
• Psychiatric News
• The Wall Street Journal
• The Baltimore Sun

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