http://www.insidezyprexa.com/index.jsp#
Answers to
Answers to questions you may have regarding agreements that Eli Lilly and Company entered into to settle the vast majority of the remaining cases in the ZYPREXA® (olanzapine) product liability litigation
Q: What are the implications for health care professionals? Have any healthcare professionals had judgments against them?
A: As a part of these agreements, plaintiffs' attorneys have agreed to dismiss all claims that had been made against healthcare professionals in any cases, relating to the prescribing of ZYPREXA, covered by these settlements. Health care professionals will not have to pay a penny toward the settlements and will not have a judgment or settlement to report. To date, no health care professional who was a party in these ZYPREXA product liability claims has had to pay anything or has had a judgment against him or her.
Q: If I was a party in a claim that was included in these settlements, what do I need to do?
A: You do not have to do anything. You or your counsel will receive notification that your case has been dismissed.
Q: Do you have resources to help me discuss the benefits and risks of ZYPREXA with my patients?
A: Yes, your Lilly sales representatives have simple-to-use materials you can use to discuss ZYPREXA's benefits and potential adverse events with those you treat. They also carry tools that are consistent with established care guidelines to help you monitor your patients as they continue their treatment.
Q: Why did Lilly settle?
A: We have been vigorously defending against these claims involving ZYPREXA because we believe they are without merit, and we will continue to do so with any remaining cases going forward. However, we decided that it was in the best interests of patients, healthcare professionals, shareholders, and employees to try to place this product liability litigation behind us.
We have heard from many of you that these lawsuits and lawyer ads stirred concern and interfered with your process of making decisions about which medication best suits an individual patient's needs.
In reaching these agreements with this collection of plaintiffs' attorneys, we have attempted to alleviate this concern. These agreements include the vast majority of current ZYPREXA product liability claims. As a part of these agreements, plaintiffs' attorneys have agreed that all claims against healthcare professionals named in any cases relating to the prescribing of ZYPREXA covered by these settlements will be dismissed. Healthcare professionals will not have to pay a penny toward these settlements and will not have a judgment or settlement to report.
Q: Will I continue to see legal ads from plaintiff attorneys related to ZYPREXA?
A: Despite concerns expressed by the Court about the validity of these claims, some lawyers continue to solicit cases. Indeed, similar product liability law suits have been filed against manufacturers of other atypical antipsychotics. Plaintiffs' attorneys have been actively running legal ads mentioning a single agent or several agents within the class. Ads mentioning multiple agents may still include ZYPREXA. If you see such an ad, please call 1-800-LILLYRX to report it.
Q: What is the purported basis for the claims?
A: In September 2003, the FDA required label changes for all atypical antipsychotics to alert doctors to the potential risk of diabetes and hyperglycemia. Information that hyperglycemia and diabetes were infrequent adverse events has, in fact, been in the product label since ZYPREXA was introduced in 1996. In most lawsuits, plaintiffs' attorneys claimed that before the label change, the information conveying the risk as an infrequent adverse event was not adequately described.
Q: How can I get a question about the settlement answered?
A: Please call 1-800-LillyRX if you have any other questions.
For complete safety profile, see the full Prescribing Information provided below.
ZYPREXA is a registered trademark of Eli Lilly and Company.
Zyrtec is a registered trademark of UCB, SA.
Important Safety Information for ZYPREXA®(Olanzapine)
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Increased Mortality in Elderly Patients with Dementia-Related Psychosis
Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks) in these patients revealed a risk of death in the drug-treated patients of between 1.6 to 1.7 times that seen in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature. ZYPREXA (olanzapine) is not approved for the treatment of elderly patients with dementia-related psychosis. |
Cerebrovascular adverse events (CVAE), including stroke, in elderly patients with dementia — Cerebrovascular adverse events (eg, stroke, transient ischemic attack), including fatalities, were reported in trials of olanzapine in elderly patients with dementia-related psychosis. In placebo-controlled trials, there was a significantly higher incidence of CVAE in patients treated with olanzapine compared to patients treated with placebo. Olanzapine is not approved for the treatment of patients with dementia-related psychosis.
Hyperglycemia and diabetes mellitus — Hyperglycemia, in some cases associated with ketoacidosis, coma, or death, has been reported in patients treated with atypical antipsychotics including olanzapine. All patients taking atypicals should be monitored for symptoms of hyperglycemia. Persons with diabetes who are started on atypicals should be monitored regularly for worsening of glucose control; those with risk factors for diabetes should undergo baseline and periodic fasting blood glucose testing. Patients who develop symptoms of hyperglycemia during treatment should undergo fasting blood glucose testing.
Neuroleptic malignant syndrome (NMS) — As with all antipsychotic medications, a rare and potentially fatal condition known as NMS has been reported with olanzapine. If signs and symptoms appear, immediate discontinuation is recommended. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmia). Additional signs may include elevated creatinine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure.
Tardive dyskinesia (TD) — As with all antipsychotic medications, prescribing should be consistent with the need to minimize the risk of TD. The risk of developing TD and the likelihood that it will become irreversible are believed to increase as the duration of treatment and the total cumulative dose of antipsychotic increase. The syndrome may remit, partially or completely, if antipsychotic treatment is withdrawn.
Medication dispensing and prescribing errors have occurred between ZYPREXA (olanzapine) and Zyrtec (cetirizine HCl). These errors could result in unnecessary adverse events or potential relapse in patients suffering from schizophrenia or bipolar disorder. To reduce the potential for dispensing errors, please write ZYPREXA clearly.
The most common treatment-emergent adverse event associated with intramuscular olanzapine vs placebo IM in 3 short-term (24-hour treatment) trials involving agitated patients with schizophrenia or bipolar mania was somnolence (6% vs 3%). Also observed (intramuscular olanzapine vs placebo IM) were dizziness (4% vs 2%), hypotension (2% vs 0%), asthenia (2% vs 1%), tremor (1% vs 0%), and postural hypotension (1% vs 0%).
The most common treatment-emergent adverse event associated with oral olanzapine (vs placebo) in 6-week acute-phase schizophrenia trials was somnolence (26% vs 15%). Other common events were dizziness (11% vs 4%), weight gain (6% vs 1%), personality disorder (COSTART term for nonaggressive objectionable behavior; 8% vs 4%), constipation (9% vs 3%), akathisia (5% vs 1%), and postural hypotension (5% vs 2%).
The most common treatment-emergent adverse event associated with oral olanzapine (vs placebo) in 3- and 4-week bipolar mania trials was somnolence (35% vs 13%). Other common events were dry mouth (22% vs 7%), dizziness (18% vs 6%), asthenia (15% vs 6%), constipation (11% vs 5%), dyspepsia (11% vs 5%), increased appetite (6% vs 3%), and tremor (6% vs 3%).
To view the entire Important Safety Information, click here.
ZYPREXA is a registered trademark of Eli Lilly and Company.
Zyrtec is a registered trademark of UCB, SA. "
Download Lilly's confidential Zyprexa documents here: http://www.furiousseasons.com/zyprexadocs.html
and phone Eli Lilly to discuss the following: http://home.comcast.net/~11.5.dcqp/AdjustmentDisorder.html
"GET AN ATTORNEY LILLY
If you see such an ad, please call 1-800-LillyRX to report it!
(olanzapine) Zyprexa® / Adjustment Disorder
Call 1-800-LillyRX if you have any other questions! "
