Healthcare Industry News: olanzapine
News Release - January 4, 2007
Eli Lilly and Company Statement Regarding Today's New York Times Article - January 4, 2007
INDIANAPOLIS, Jan. 4 (HSMN NewsFeed) -- Eli Lilly and Company (NYSE: LLY ) believes it is inaccurate to imply that any single factor -- including medication -- was the cause of the unfortunate death of the patient profiled in today's New York Times.Millions of patients around the world have benefited from Zyprexa and Lilly is concerned that this tragic story about a single patient could unnecessarily frighten people with schizophrenia and bipolar disorder and cause them to discontinue their medication without first consulting a physician. Furthermore, we are disappointed that the Times chose to focus its entire article on only one patient rather than speaking with additional patients and/or family members who have different views and experiences with Zyprexa. We encourage patients or caregivers with questions to consult their treating physicians or to call Lilly at 1-800-LILLY-RX.
Lilly released the following statement to the Times to ensure patients who take this medication have the information and reassurance they need.
"Lilly is saddened by the death of Mr. Kauffman and our deepest sympathy goes out to his family and friends.
"We were made aware of this patient's death and reported it -- as we do all adverse event reports we receive -- to the FDA. It is well-understood that adverse event reports don't signal causation -- they only signal that the individual was taking a particular drug at the time of a health event.
"Though we do want to protect this patient's privacy, we want to provide enough information to reassure the millions of patients who are taking this lifesaving medication.
"To that end, it is important to note that the adverse event report indicates that this patient had a complicated medical history that may have led to this unfortunate outcome.
"Numerous studies have demonstrated that people with severe mental illness, such as bipolar disorder, have significant co-morbid medical conditions, such as cardiovascular disease and diabetes, regardless of whether they take medication and regardless of which medication they may take. Other studies have found that the health burden of severe mental illness can reduce life expectancy by between 8-20 years when compared to the general population. Very often other risk factors like heavy smoking and drinking for example complicate the medical condition of patients suffering from severe mental illness.
"Patient safety is our first priority at Lilly. We take seriously and thoroughly examine all adverse event reports received through post-marketing surveillance (also known as spontaneous adverse event reporting), from both health care professionals and consumers. We follow up on reports diligently and intensely -- as we did in this case. Although these reports are not publicly available, they are shared routinely with regulatory authorities. It is widely accepted that these reports do not address causality but they are important and can help guide further evaluation into potential safety signals. However, they cannot be interpreted in isolation from clinical trial data.
"Zyprexa was approved by the FDA in 1996 and remains on the market today. It has been the subject of nearly 100 studies over the past 23 years and has been used by more than 20 million people worldwide. Doctors continue to prescribe it to deal with some of the most terrible mental illnesses, such as schizophrenia and bipolar disorder. The FDA has looked at the entire body of evidence that Lilly has continued to provide over the years, and has affirmed the benefit that this medicine can give to patients when accompanied by appropriate labeling regarding benefits and risks.
"We remain confident in the safety and efficacy of Zyprexa based on the depth and breadth of scientific research conducted around the world. Zyprexa is a lifesaving drug and it has helped millions of people worldwide with schizophrenia and bipolar disorder regain control of their lives."
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 20 million people worldwide.
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.
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.
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.
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.
Corporate News C-LLY
Zyprexa® (olanzapine, Lilly)
Source: Eli Lilly
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