Healthcare Industry News: olanzapine
News Release - March 12, 2008
Statement from Eli Lilly and Company: Response to Connecticut Attorney General News Release
INDIANAPOLIS, March 12 (HSMN NewsFeed) -- Eli Lilly and Company (NYSE: LLY ), strongly disagrees with the characterization of company practices as alleged by the Connecticut Attorney General Richard Blumenthal in a news release issued March 11, 2008.The tone and content of the release is a disservice to patients who may currently be taking Zyprexa to treat a life-threatening disease. Specifically, the news release contained no acknowledgement of the seriousness of schizophrenia or bipolar disorder, no reference to the importance of treatment stability, and provided no guidance to patients who may now have questions about their treatment.
Given the lack of complete information in the news release, Lilly offers the following:
-- Patients should continue with medications that have been prescribed and
discuss their concerns with their doctor.
-- Patients can get information about Zyprexa by contacting the
LillyAnswers Center at 1-800-LillyRx (1-800-545-5979) or going to the
Zyprexa website at www.zyprexa.com.
Zyprexa is a lifesaving medication that has been taken by more than 23 million people worldwide. We remain confident in the safety and efficacy of Zyprexa based on the depth and breadth of scientific research conducted around the world.
Lilly is committed to the highest ethical standards and to promoting our medications only for approved uses. We have clear guidelines and extensive training for our sales representatives to help assure that they provide appropriate promotional information that is within the scope of prescribing information approved by the FDA.
We believe these claims are without merit and we will vigorously defend against them.
Zyprexa Background
Zyprexa is indicated in the United States for the short- and long-term treatment of schizophrenia, acute mixed and manic episodes of bipolar I disorder, and maintenance treatment of bipolar disorder. Since Zyprexa was introduced in 1996, it has been prescribed to approximately 23 million people worldwide. Zyprexa is not approved for patients under 18 years of age.
Zyprexa is not approved for the treatment of patients with dementia related psychosis. Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared with those patients taking a placebo.
In addition, compared to elderly patients with dementia-related psychosis taking a placebo, there was a significantly higher incidence of cerebrovascular adverse events in elderly patients with dementia-related psychosis treated with Zyprexa.
Hyperglycemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics, including Zyprexa.
While relative risk estimates are inconsistent, the association between atypical antipsychotics and increases in glucose levels appears to fall on a continuum and olanzapine appears to have a greater association than some other atypical antipsychotics. Physicians should consider the risks and benefits when prescribing olanzapine to patients with an established diagnosis of diabetes mellitus, or who have borderline increased blood glucose level. Patients taking olanzapine should be monitored regularly for worsening of glucose control. Persons with risk factors for diabetes who are starting on atypical antipsychotics should undergo baseline and periodic fasting blood glucose testing. Patients who develop symptoms of hyperglycemia during treatment should undergo fasting blood glucose testing.
Undesirable alterations in lipids have been observed with olanzapine use. Clinical monitoring, including baseline and follow-up lipid evaluations in patients using olanzapine, is advised. Significant, and sometimes very high, elevations in triglyceride levels have been observed with olanzapine use. Modest mean increases in total cholesterol have also been seen with olanzapine use.
Potential consequences of weight gain should be considered prior to starting olanzapine. Patients receiving olanzapine should receive regular monitoring of weight.
As with all antipsychotic medications, a rare and potentially fatal condition known as NMS has been reported with Zyprexa. 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.
Also, as with all antipsychotic treatment, prescribing should be consistent with the need to minimize Tardive Dyskinesia (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.
Other potentially serious adverse events include low blood pressure, seizures, elevated prolactin levels, elevated liver enzymes, cognitive and motor impairment, body temperature elevation, and trouble swallowing.
The most common treatment-emergent adverse event associated with Zyprexa in placebo-controlled, short-term schizophrenia and bipolar mania trials was somnolence. Other common events were dizziness, weight gain, personality disorder (COSTART term for nonaggressive objectionable behavior), constipation, akathisia, postural hypotension, dry mouth, asthenia, dyspepsia, increased appetite and tremor.
Full prescribing information, including a boxed warning, is available at www.zyprexa.com.
About Lilly
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers - through medicines and information - for some of the world's most urgent medical needs. Additional information about Lilly is available at www.lilly.com.
Zyprexa® (olanzapine, Lilly)
Source: Eli Lilly
Issuer of this News Release is solely responsible for its
content.
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