Zyprexa®
Drug Injuries
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:Do not discontinue taking any medications without first consulting your physician.
- Journal of the American Medical Association, Vol. 286, No. 20, 11/28/01.
- Pharmacotherapy, Vol. 22, No. 7, 7/2/02.
- 2004 Safety Alert: Zyprexa from www.fda.govaccessed on 10/18/05.
- FDA Orders New Warning on Atypical Antipsychotics from Psychiatric News, May 6, 2005 accessed on 10/18/05.
- “Drug Debate: New Antipsychotics Pose a Quandary for FDA, Doctors,” Wall Street Journal, 4/11/03.
- “Studies link Zyprexa to diabetes deaths,” the Baltimore Sun, 3/19/03.
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
