Eli Lilly's Zyprexa Prompts Debate About "Off-Label" Use

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Main Category: Pharma Industry / Biotech Industry
Also Included In: Alzheimer's / Dementia;  Bipolar;  Schizophrenia
Article Date: 18 Dec 2006 - 6:00 PDT

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According to reports in the media today, drug company Eli Lilly has allegedly been promoting off-label use of antipsychotic drug olanzapine (branded as Zyprexa) to treat dementia. Olanzapine is approved by the FDA for the long term treatment of schizophrenia, maintenance treatment of bipolar disorder, as well as treatment of certain types of acute episodes of bipolar disorder.

It has been reported that a US lawyer handling the lawsuits of mentally ill patients is in receipt of internal marketing documents belonging to Eli Lilly, that allegedly contain evidence of a long standing campaign to influence doctors to prescribe Zyprexa for non-approved use, specifically to elderly patients with dementia.

A representative of the company has denied the allegation stating that their sales training does not encourage reps to give doctors information that is outside the FDA's approved use of the drug.

While federal law makes it illegal for drug companies to promote drugs for non-approved use, doctors have the right to prescribe what they consider the best treatment for their patients. This is where "off-label" use - that is using a drug approved for one condition to treat another - comes into practice.

In the UK, according to the Medicines and Healthcare products Regulatory Agency (MHRA), in 2003 some 9,000 patients were prescribed olanzapine to treat dementia. They stated in a report on the drug in 2004 that: "Antipsychotics are licensed to treat acute psychosis and schizophrenia. However, they are also prescribed off-label to treat behavioural problems in older people with dementia and clinical trials show some evidence of benefit to patients."

The FDA information that accompanies the Zyprexa prescription warns that the drug can be fatal to elderly dementia sufferers, and in 2004, in the UK, the Committee for the Safety of Medicines (CSM) reported that olanzapine and risperidone (another antipsychotic) should not be given to elderly dementia sufferers because of the increased risk of strokes.

Sir Alasdair Breckenbridge, Chair of MHRA, said at the time of the 2004 CSM report that:

"Antipsychotics are not licensed for the treatment of behavioural problems in dementia but we know they are used in these patients outside their licensed indications where prescribers make a judgement on their own responsibility that it is the right treatment for a particular patient".

The FDA's patient information on Zyprexa lists some of the potential side-effects of the drug which include increased chance of death in the elderly, a life threatening nervous system problem termed Neuroleptic Malignant Syndrome (NMS), a movement problem called Tardive Dyskinesia (TD), high blood sugar and diabetes, strokes, dizziness, dry mouth and constipation.

In a nutshell, the debate hinges on actively promoting off-label use versus making available information about off-label use. The regulators have to consider the safety of the average patient. But doctors need all the facts because they have a responsibility to give each patient the best care possible given their individual circumstances. And sometimes, in their professional opinion, the only drug that will alleviate the symptoms will be one that is approved for another condition, albeit with (known) risks.

Click here for patient information sheet on Zyprexa (FDA).

Written by: Catharine Paddock
Writer: Medical News Today


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