Is This Scientific Enough Victoria?

http://www.fda.gov/medwatch/SAFETY/2004/risperdal.htm

The following information is from Janssen Pharmaceutica, Inc. Contact the company for a copy of any referenced enclosures.

Dear Health Care Provider,

Janssen Pharmaceutica, Inc. would like to inform you of important labeling changes regarding Risperdal ® (risperidone). The FDA has asked all manufacturers of atypical antipsychotic medications, including Janssen Pharmaceutica, Inc. to add a Warnings statement describing the increased risk of hyperglycemia and diabetes in patients taking these medications, including Risperdal.

Accordingly, the Risperdal Prescribing Information has been updated with the addition of the following information:

WARNINGS

Hyperglycemia and Diabetes Mellitus
Hyperglycemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics, including Risperdal. Assessment of the relationship between atypical antipsychotic use and glucose abnormalities is complicated by the possibility of an increased background risk of diabetes mellitus in patients with schizophrenia and the increasing incidence of diabetes mellitus in the general population. Given these confounders, the relationship between atypical antipsychotic use and hyperglycemia-related adverse events is not completely understood. However, epidemiological studies suggest an increased risk of treatment-emergent hyperglycemia-related adverse events in patients treated with the atypical antipsychotics. Precise risk estimates for hyperglycemia-related adverse events in patients treated with atypical antipsychotics are not available. Patients with an established diagnosis of diabetes mellitus who are started on atypical antipsychotics should be monitored regularly for worsening of glucose control.

Patients with risk factors for diabetes mellitus (eg, obesity, family history of diabetes) who are starting treatment with atypical antipsychotics should undergo fasting blood glucose testing at the beginning of treatment. Any patient treated with atypical antipsychotics should be monitored for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. Patients who develop symptoms of hyperglycemia during treatment with atypical antipsychotics should undergo fasting blood glucose testing. In some cases, hyperglycemia has resolved when the atypical antipsychotic was discontinued; however, some patients required continuation of anti-diabetic treatment despite discontinuation of the suspect drug.

If you have any questions regarding this important safety information, please contact Janssen Medical Affairs at 1-800-JANSSEN. Please refer to the full prescribing information for RISPERDAL included with this letter. As always, we request that serious adverse events be report to Janssen at 1-800-JANSSEN or to the FDA MedWatch program by phone (1-800-FDA-0188), by fax (1-800-FDA-0178), or by e-mail (www.fda.gov/medwatch).

Sincerely,

Ramy A. Mahmoud, MD, MPH
Vice President, CNS
Janssen Medical Affairs, LLC

AND THIS!

IMPORTANT DRUG INFORMATION

16-April-2003

Dear Healthcare Provider,

Janssen Pharmaceutica Products, L.P., would like to inform you of important changes regarding RISPERDAL (risperidone). The RISPERDAL prescribing information has been updated with the addition of the following information:

WARNINGS
Cerebrovascular Adverse Events, Including Stroke, in Elderly Patients with Dementia
Cerebrovascular adverse events (e.g., stroke, transient ischemic attack), including fatalities, were reported in patients (mean age 85 years; range 73-97) in trials of risperidone in elderly patients with dementia-related psychosis. In placebo-controlled trials, there was a significantly higher incidence of cerebrovascular adverse events in patients treated with risperidone compared to patients treated with placebo. RISPERDAL has not been shown to be safe or effective in the treatment of patients with dementia-related psychosis.

This update is based on data from 4 placebo-controlled trials conducted in elderly patients with dementia (N=1230). Additional information on these and other clinical trials conducted in elderly patients can be obtained by calling 1-800-JANSSEN (800-526-7736). We remind you that, like all other antipsychotics, RISPERDAL is not indicated for the treatment of dementia.

Janssen Pharmaceutica Products, L.P., remains committed to providing you with the most current product information available for the management of your patients. Please refer to the enclosed package insert for full prescribing information. As always, we request that serious adverse events be reported to Janssen at 1-800-JANSSEN (526-7736) or to the FDA MedWatch program by phone 1-800-FDA-1088, by fax
(1-800-FDA-0178), or by email (www.fda.gov/medwatch). For additional medical information about RISPERDAL or any other Janssen product, please call 1-800-JANSSEN (526-7736) from 9AM to 5PM EST, Monday through Friday.

Sincerely,

Christine Cote, MD
Vice President, Medical Affairs
Janssen Pharmaceutica Inc.

AND THIS!

FDA tells Janssen to stop misleading Risperdal claims and promotions

-April 27, 2004

The FDA warned Risperdal maker Janssen Pharmaceuticals, a unit of Johnson & Johnson that its November 2003 letter issued to doctors was misleading. According to the FDA, the letter failed to disclose information added to Risperdal’s labeling regarding excess blood sugar and diabetes risks, in addition to minimizing the risk of serious events like death and coma.

Also excluded from the letter was the recommendation for regular testing for diabetes. The company made misleading claims indicating Risperdal is a safer choice than competing atypical antipsychotics. Janssen is to stop any distribution of promotions containing similar messages and to then issue more accurate and complete information to the recipients of the former letter.

AND THIS!

http://www.fda.gov/medwatch/SAFETY/2004/risperdal.htm

MedWatch Safety Alert (2004)
Dear Doctor: Hyperglycemia and Diabetes Mellitus

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http://www.fda.gov/medwatch/SAFETY/2003/risperdal.htm

MedWatch Safety Alert (2003)
WARNINGS: Cerebrovascular Adverse Events, Including Stroke, in Elderly Patients with Dementia

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