RPhLink.com  The Pharmaceutical Care Network!                            09/13/04 From AstraZeneca On June 9, 2004, AstraZeneca announced a labeling change in the European Union (EU) for the company's cholesterol-lowering medication CRESTOR (rosuvastatin calcium). The labeling revisions address prescribing patterns in Europe by stressing the importance of using CRESTOR appropriately, particularly in the very small number of patients who require the highest dose of 40 mg. Following the announcement of the European labeling change, the US Food and Drug Administration (FDA) posted a Public Health Advisory for CRESTOR on its website (www.fda.gov/cder). A Public Health Advisory is a method the FDA utilizes to disseminate information that may possibly cause confusion among health care providers. The Public Health Advisory posted for CRESTOR alerts health care providers that the EU labeling changes are already captured in the FDA-approved labeling for CRESTOR. The FDA reiterated that they are not proposing to change the US labeling for CRESTOR, and reemphasized to physicians the importance of carefully following the recommendations in the current product label. Other countries may respond individually to the EU labeling change, and determine if any action is necessary to reinforce appropriate prescribing guidelines. For example, AstraZeneca Canada has sent a reminder to physician to reinforce the prescribing guidelines. For example, AstraZeneca Canada has sent a reminder to physicians to reinforce the prescribing guidelines. CRESTOR is a safe and effective therapy as an adjunct to diet for the treatment of dyslipidemia. The safety profile of CRESTOR remains similar to that of all other currently marketed statins, based on an analysis of postmarketing safety data involving nearly two million patients worldwide and more than five million prescriptions dispensed. AstraZeneca wants to ensure that CRESTOR is used both safely and effectively and believes that caution should be used when titrating CRESTOR to its highest approved dose of 40 mg, as directed in our Prescribing information. For your background and information, we have included a copy of the FDA Public Health Advisory, a Q&A and patient Fact Sheet to assist you in addressing patient questions that arise from press on this topic. Please note the important information about CRESTOR, including the enclosed full Prescribing Information or call 1-800-236-9933 if you have any unresolved questions. Sincerely, James Blasetto, MD, MPH Executive Director Strategic Development

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     From: biogen idec                                                  03-10-04 Biogen Idec has reintroduced through the wholesaler supply chain lyophilized AVONEX(Interferon beta-1a) Administration Packs (4x1 week IM Injection) effective immediately.  Thus you are now carrying two NDC numbers for AVONEX, AVONEX in a prefilled syringe (NDC #59627-0002-05) and AVONEX lyophilized formulation (NDC #59627-0001-03). The decision to bring back AVONEX lyophilized formulation was driven by some patients who prefer this formulation over AVONEX in a prefilled syringe and a disire to meet customer needs.  We estimate that the majority of your prescriptions of AVONEX will continue to be with the more convenient prefilled syringe of AVONEX. Physicians are being asked to specify which formulation of AVONEX they would like their patients to have to reduce any confusion for you when filling the AVONEX prescription.                                                  When prescribing AVONEX in a prefilled syringe (NDC #59627-0002-05), physicians have been instructed to write "AVONEX -PREFILLED SYRINGE." When prescribing AVONEX as the lyophilized (powdered) form (NDC #59627-0001-03), physicians have been instructed to write "AVONEX-lyo vial."   We appreciate your continued support of your patients and AVONEX.  If you or your patients have questions, please feel free to contact MS ActiveSource, the Biogen Idec customer service center, at 1-800-456-2255.        Matt Minczeski                                                                                                                                          Associate Director Trade Development Please not that storage conditions for AVONEX lyophilized formulation and AVONEX prefilled formulation both require refrigeration. Please see full prescribing information at www.Avonex.com