Zyprexa Risks

The following are the risks and side effects associated with Zyprexa therapy. This list is not exhaustive. From the FDA web site, Zyprexa’s risks include:

• A life-threatening nervous system problem called neuroleptic malignant syndrome (NMS). NMS can cause a high fever, stiff muscles, sweating, a fast or irregular heart beat, change in blood pressure, and confusion. NMS can affect your kidneys. NMS is a medical emergency. Call your healthcare professional right away if you experience these symptoms.
• A movement problem called tardive dyskinesia (TD). Call your healthcare professional right away if you get muscle movements that cannot be stopped.
• High blood sugar and diabetes. Patients with diabetes or who have a higher chance for diabetes should have their blood sugar checked often.
• Strokes have happened in older patients treated for mental illness from dementia. Zyprexa is not approved for this use. See FDA Alert.
• Other serious side effects include low blood pressure seen as dizziness, and possibly fainting; increased heart beat; seizures; liver problems; increased body temperature; and difficulty swallowing.
• The most common side effects include sleepiness, dry mouth, dizziness, restlessness, constipation, upset stomach, weight gain, increased appetite, and tremor.

Zyprexa Settlement

Eli Lilly has already agreed to a Zyprexa settlement including some $700 Million to those injured by the drug. In September 2003, the FDA required changes to the Zyprexa warning label to clearly alert the risk of diabetes and hyperglycemia associated with the drug.

Zyprexa Lawsuits: seeking a personal injury lawyer

Do you suffer from diabetes or another condition as a result of Zyprexa? Your injuries as a result of Zyprexa may entitle you to legal compensation.

If you think you have a Zyprexa lawsuit, contact GPW for a free, confidential legal consultation, through our web form or call 1-800-471-3980 now.

For over twenty years, the lawyers of GPW have represented people injured by defective products. Learn more about GPW.

When finalized, the settlement will resolve the majority of Zyprexa claims pending in the United States. This includes federal and state lawsuits that have been brought against Lilly, the filed nationwide class action lawsuits (none of which had been certified by a judge), and the majority of approximately 5,000 claims that were the subject of “tolling agreements” that extended the deadline for potential claimants to file a lawsuit, as well as other potential claims against Lilly. The agreement will also result in the dismissal of claims against physicians and other health care professionals named as co-defendants in any cases covered by this settlement.

According to the agreement, Lilly will establish a fund not to exceed $690 million for plaintiffs who agree to settle their claims. The settlement fund will be overseen and distributed by claims administrators appointed by the plaintiffs’ steering committee. At this time, the exact number of claimants covered by this settlement is unknown, but is estimated to be 8,000, comprising approximately 75 percent of claims identified to Lilly.

“We believe that this settlement is in the best interest of our clients, as well as patients, physicians and caregivers,” said Christopher Seeger, member of the plaintiffs’ steering committee, which had been directing the federal litigation for the claimants. “Our interest is in seeing that Zyprexa patients get the best medical care available and that doctors and patients receive accurate and meaningful information about the medications they use. We are pleased with the manner in which Lilly handled these claims. The patient population to which this drug is given has difficult medical histories. Protracted litigation was in no one’s interest.”

Most of the lawsuits claimed that before September 2003, the information in the medication label, which listed the risk of hyperglycemia and diabetes as an infrequent adverse event since 1996, was not adequately displayed. In September 2003, the FDA required label changes for all atypical antipsychotics to warn against this risk. “Given the background rate of diabetes in the population at large, and particularly in people with serious mental illness,” said Seeger, “we are pleased with the label change and the additional information being provided to physicians and their patients about both the risks and benefits of the drug.”

“The litigation stirred concern for physicians and spread fear among patients and caregivers, which has interfered with the process of physicians making treatment decisions,” added Taurel. “We want physicians to feel comfortable choosing the medication they believe best meets the treatment needs of their patients with serious mental illness.”

The agreement involves claimants who asserted that they developed diabetes-related conditions from their use of Zyprexa. Claimants who are not covered by the final settlement are those represented by attorneys who are not participating in the agreement in principle. Lilly is prepared to continue its vigorous defense of Zyprexa in the remaining cases.

Lilly advised investors that it anticipates taking at least a $700 million pretax charge in the second quarter of 2005 to cover this settlement, as well as other product liability claims not covered by the settlement. This second quarter charge will be excluded from Lilly’s adjusted second-quarter earnings.

Zyprexa(R) Background

Zyprexa(R) 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(R) was introduced in 1996, it has been prescribed to more than 17 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 to placebo. In addition, compared to 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.

Prescribing should be consistent with the need to minimize the risk of neuroleptic malignant syndrome, tardive dyskinesia, seizures, and orthostatic hypotension.

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 boxed warning, is available at http://www.zyprexa.com .

Today’s advisory applies to such antipsychotic drugs as Abilify (aripiprazole), Zyprexa (olanzapine), Seroquel (quetiapine), Risperdal (risperidone), Clozaril (clozapine) and Geodon (ziprasidone). Symbyax, which is approved for treatment of depressive episodes associated with bipolar disorder is also included in the agency’s advisory.

FDA is requesting that the manufacturers of all of these kinds of drugs add a boxed warning to their drug labeling describing this risk and noting that these drugs are not approved for the treatment of behavioral symptoms in elderly patients with dementia. Patients receiving these drugs for treatment of behavioral disorders associated with dementia should have their treatment reviewed by their health care providers.

In analyses of seventeen placebo-controlled studies of four drugs in this class, the rate of death for those elderly patients with dementia was about 1.6 to 1.7 times that of placebo. Although the causes of death were varied, most seemed to be either heart-related (such as heart failure or sudden death) or from infections (pneumonia).

The atypical antipsychotics fall into three drug classes based on their chemical structure. Because the increase in mortality was seen with atypical antipsychotic medications in all three chemical classes, the agency has concluded that the effect is probably related to the common pharmacologic effects of all atypical antipsychotic medications, including those that have not been studied in the dementia population.

The agency is considering adding a warning to the labeling of older antipsychotic medications because limited data also suggest a similar increase in mortality for these drugs. The review of the data on these older drugs, however, is still on-going.

Additional information concerning today’s announcement is available on FDA’s Web site at http://www.fda.gov/cder/drug/infopage/antipsychotics/default.htm and
http://www.fda.gov/cder/drug/advisory/antipsychotics.htm.