RPhLink.com  The Pharmaceutical Care Network! RPhLink.com July 21, 2004 From: Janssen Pharmaceutica Inc. Health care Provider: The Food Drug Administration's (FDA) Division of Drug, Marketing, Advertising, and Communications (DDMAC) has asked us to contact you because Janssen Pharmaceutica Products, L.P. recently received a warning Letter concerning the promotion of Risperdal (risperidone). This letter provides important corrective information about Risperdal relating to hyperglycemia and Diabetes Mellitus. The Warning Letter concludes that Janssen disseminated a Risperdal Dear Health Care Provider (DHCP) dated November 10, 21003 that omitted material information about Risperdal, minimized potentially fatal risks, and made misleading claims suggesting superior safety to other atypical antipsychotics without adequate substantiation, in violation of the Federal Food, Drug and Cosmetic Act. Specifically, the Warning Letter stated that the DHCP letter omitted important information regarding hyperglycemia and diabetes, including the potential consequences and the recommendation of regular glucose control monitoring that was added to the approval product labeling for Risperdal; minimized the potentially fatal risks of hyperglycemia-related adverse events such as ketoacidosis, hyperosmolar coma and death; minimized the importance of blood glucose monitoring; suggested that Risperdal did not increase the risk of diabetes, contradicting the Warning in the revised product labeling; and made misleading claims suggesting that Risperdal has a lower risk of hyperglycemia and diabetes than other atypical antipsychotics without adequate substantiation which is inconsistent with the Prescribing Information for Risperdal. In order to provide you with complete and accurate information regarding hyperglycemia and Diabetes Mellitus relative to Risperdal, please be advised that the Risperdal Prescribing Information was updated with addition of the Warning in November 2003. 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 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 (e.g., obesity, family history of diabetes) who are starting treatment with atypical antipsychotics should undergo fasting blood glucose testing at the beginning of treatment and periodically during 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 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 reported to Janssen at 1-800-Janssen or the FDA MedWatch program by phone (1-800 FDA-0178), or by e-mail (www.fda.gov).   Ramy Mahmoud, MD, MPH Vice President, CNS Janssen Medical Affairs, LLC

From: ABBOTT                                                           03-10-2004 February 24.2004 Recent, Abbott Laboratories, MediSense Products discovered that counterfeit packaging for Precision QID Blood Clucose Test Strips has entered the distribution channel.  Since the identified product was repackaged by an unknown source, we cannot confirm that the repackaging  was conducted i a manner sonsistent with Good Manufacturing Practices.  In addition, we found that the counterfeit packaging contained several labeling inconsistencies.  When such repackaging occurs, we are unable to guarantee the accuracy of the claims contained on the package labeling.  The distributor who purchased and resold the affected product has begun a "distributor initiated" recall.  The U.S. Food and Drug Administration (FDA) have been notified of the recall. We became aware of the counterfeit packaging when a distributor returned it to us through our normal return goods process.  Apparently, this distributor purchased the product from the alternate source market.  Also known as the gray or diverted market, the alternate source market encompasses product purchased from any source other than the original manufacturer or an authorized distributor,  Purchasing from the alternate source market provides the opportunity for potentially aduterated or misbranded product to enter the U.S. distribution channel, in violation of the Federal Food, Drug & Cosmetic Act.  This unauthorized repackaging also violates the Federal Lanham Act and copyright laws. Because we cannot be sure how the repackagers are handling, storing, packaging and/ordistributing this repackaged product, Abbott Laboratories, MediSense Products cannot assure consumers and health care professionals of the quality and/or accuracy of the product/labeling purchased from the alternate source market. We take the discovery of this counterfeit packaging veryseriously.  We have contacted the FDA and are working closely with them durng their investigation of this issue.  To minimize your risk of receiving compromised product, we recommend that you contact your distributor(s) and ask if they purchase any MediSense Blood Glucose Products from the alternate source market.  Further, you may wish to request assurances from your distributors that the products you are purchasing as packaged are not from the alternate source market.  We recommend that you purchase our product from those who purchase only directly from us.  We believe this action is necessary to maximize the intergrity of the health care supply chain. Thank you for your  cooperation and assistance.  If you have any questions concerning this letter, please call 1-800-537-3575. John Landgraf, Corporate Vice President                                                                                                                         Medical Products Group Quality Assurance                                                                                                P/N 487895 Rev. 02/04