Zyprexa (olanzapine)

Zyprexa (olanzapine) is an oral medication used to treat the symptoms of schizophrenia, acute mixed or manic episodes of bipolar I disorder, and for maintenance treatment of bipolar disorder. Manufactured by Eli Lilly and Company, Zyprexa was the first of a newer generation of antipsychotic medications (called atypical antipsychotics) approved for the long-term treatment of schizophrenia. The drug works by blocking receptors for several neurotransmitters (chemicals that nerves use to communicate with each other) in the brain.

NEWS February 6, 2008 FDA to meet about Zyprexa Safety

The FDa will meet on Wednesday to determine the safety to a long lasting version of Zyprexa, made by Eli Lilly.

Zyprexa has fallen under heavy scrutiny over the past few years by consumer advocacy groups and medical professionals pointing towards the dangerous and sometimes deadly side effects linked to its use; diabetes, diabetic coma, pancreatitis and in rare cases even death. There have already been two large scale rounds of thousands of lawsuits that the company has settled with plaintiff lawyers for hundreds of millions of dollars.

There will be a panel of outside experts evaluating the safety and effectiveness of the drug Zyprexa Adhera, which is an injectable version of the drug. Although many times they do, the FDA is not bound by law to follow the advice the panel of experts provides. Scientists’ of the FDA have noted that although he drug appears to work, it does seem to have an increased sedation effect among a portion of patients, which may warrant a black box warning to alert doctors and patients to the possible dangers.

Lilly states that the sedation effect is almost certainly caused by physicians performing improper injections and it not due to the drug itself.

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Why Prescribed

Zyprexa is prescribed to treat schizophrenia and acute manic episodes associated with bipolar I disorder.

FDA Approved Uses

Zyprexa was approved by the FDA in 1996 for the treatment of schizophrenia and acute mixed or manic episodes associated with bipolar disorder. It is also used as maintenance therapy for bipolar disorder and treating agitation due to schizophrenia or bipolar disorder.

Side Effects

Side effects associated with Zyprexa include akathisia (an inability to sit still), constipation, dizziness, drowsiness, insomnia, dry mouth, orthostatic hypotension, tremor, and weight gain.

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Warnings and Alerts

In 2005, the FDA issued a public health advisory to alert health care providers, patients, and patient caregivers to new safety information concerning the use of certain drugs called "atypical antipsychotic drugs," such as Zyprexa. These drugs are approved for the treatment of schizophrenia and mania, but clinical studies of these drugs to treat behavioral disorders in elderly patients with dementia have shown a higher death rate associated with their use compared to patients receiving a placebo (sugar pill).

Further, rare but potentially fatal disorders reported with Zyprexa use include neuroleptic malignant syndrome (NMS) and tardive dyskinesia (TD). NMS is a severe condition that can cause severe muscle rigidity and spikes in blood pressure and pulse, while TD causes spastic movements of the face, tongue, or other parts of the body. TD may become permanent, and the risk of TD is believed to increase as the amount of and length of time on these medications increase. Other dangerous side effects reported with Zyprexa include excessive weight gain, juvenile diabetes, pancreatitis, and diabetic coma.

Drug Contraindications

Zyprexa is contraindicated in patients with a history of seizures, cardiovascular disease, cerebrovascular disease, dehydration, diabetes, hyperglycemia, pancreas problems, hypovolemia, Alzheimer's disease, hypothyroidism, pregnancy, and hepatic impairment.

FAQ's

What is schizophrenia?

Schizophrenia is a mental illness that usually strikes in late adolescence or early adulthood, and is characterized by disturbances of language and communication, thought disturbances that may involve distortion of reality, misperceptions, delusions and hallucinations, mood changes and withdrawn, regressive, or bizarre behavior lasting longer than six months. The causes of schizophrenia are not clear. The symptoms seem to indicate an imbalance in the actions of two brain chemicals: dopamine and serotonin. Scientists think that a malfunction of neurones in the brain areas that deal with emotions, memory and planning (the limbic system and frontal lobes) may be the cause.

What should I tell my doctor before he or she prescribes Zyprexa?

Before using Zyprexa, tell your doctor if you have or had heart problems, cataracts, a thyroid disorder, high cholesterol or triglycerides, seizures, diabetes or increased blood sugar, liver disease, are trying to become pregnant, are already pregnant, are breast-feeding, or drink alcohol.

What is Neuroleptic Malignant Syndrome (NMS)?

Neuroleptic Malignant Syndrome (NMS) is a potentially fatal condition that has been associated with the administration of antipsychotic drugs. 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.

The management of NMS should include immediate discontinuation of all antipsychotic drugs, such as Zyprexa, intensive monitoring of symptoms and treatment of any associated medical problems.

What is Tardive Dyskinesia?

Tardive Dyskinesia is a syndrome of potentially irreversible, involuntary, dyskinetic movements that can develop in patients treated with antipsychotic drugs, such as Zyprexa. Although the prevalence of the syndrome appears to be highest among the elderly, especially elderly women, it is impossible to rely upon prevalence estimates to predict, at the beginning of antipsychotic treatment, which patients are likely to develop the syndrome. Whether antipsychotic drug products differ in their potential to cause tardive dyskinesia is unknown.

Given these considerations, Zyprexa should be prescribed in a manner that is most likely to minimize the risk of tardive dyskinesia. As with any antipsychotic drug, Zyprexa should be reserved for patients who appear to be receiving substantial benefit from the drug. In such patients, the lowest effective dose and the shortest duration of treatment should be sought.

Can I bring a lawsuit if I have suffered injuries from taking Zyprexa?

If you or a loved one has suffered serious side effects from using Zyprexa, particularly diabetic complications and/or cardiovascular difficulties, you may be entitled to recover damages. Manufacturers of dangerous drugs can be held legally liable for their products and associated negligence. Contact a qualified defective drug litigation attorney today, who can evaluate your case and explain your legal options.