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| |  Health Canada Endorses Important Safety Information Regarding Medication Errors Involving Reminyl (Galantamine Hydrobromide) and Amaryl (Glimepiride) TORONTO, ON -- December 22, 2004 -- Janssen-Ortho Inc. and Aventis Pharma Inc., (collectively, "the Companies") in consultation with Health Canada, have informed Canadian health care professionals of reports of prescribing and dispensing errors in the United States between Reminyl* (galantamine hydrobromide), a Janssen-Ortho prescription medication for mild to moderate Alzheimer's disease, and Amaryl® (glimepiride), an Aventis Pharma prescription medication for type 2 diabetes. - There have been errors in prescribing and dispensing of the medications Reminyl and Amaryl. The Companies are aware of 36 reports, of which 12 were confirmed, of prescriptions that were either incorrectly written, interpreted, labeled or filled due to the similarity in names between Reminyl and Amaryl. These reports include instances in which Reminyl was prescribed but Amaryl was incorrectly dispensed, leading to various adverse events including severe hypoglycemia (lowering of blood sugar). There were two reports of death subsequent to the medication error. To the Companies' knowledge all reports originated in the US and the Companies are unaware of any reports of medication errors in Canada. In order to raise awareness and to educate prescribers and pharmacists about these medication errors, The Companies are developing a communication program to help prevent medication prescribing and dispensing errors. The program includes outreach to pharmacists, physicians and patient associations through a variety of targeted communications. These two products have an overlapping strength (4mg) and an overlapping dosage (tablets). In addition, both products have generic names (galantamine vs. glimepiride) that may lead to their storage in close proximity. It is important to note that Reminyl has a starting dosage of 4 mg TWICE a day, whereas Amaryl is usually initiated at 1 mg ONCE daily. The Companies have provided this information to physicians and pharmacists across Canada. This advisory and the letters issued to physicians and pharmacists can be accessed at Health Canada's web site at: http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd- dpt/index_advisories_professionals_e.html This information is also available at http://www.janssen-ortho.com/ or http://www.aventispharma.ca. For more information, patients should consult their health care professional. Patients should NOT discontinue their medication without consulting their physician or pharmacist first. If you or your caregiver have questions about your current prescription, please talk to your doctor or take the pills back to your pharmacy and speak with your pharmacist. As with all medications, Reminyl and Amaryl should not be used by anyone who does not require the drug to treat a disease or its symptoms. Janssen-Ortho Inc. is a research-based pharmaceutical company located in Toronto, Ontario. Aventis Pharma Inc. is a research-based pharmaceutical company located in Laval, Quebec. The identification, characterization, and management of marketed health product-related adverse reactions are dependent on the active participation of health care professionals in adverse reaction reporting programmes. Any occurrences of prescribing or dispensing errors or other serious and/or unexpected adverse reactions in patients receiving Reminyl or Amaryl should be reported to Janssen-Ortho Inc. (for Reminyl), Aventis Pharma Inc. (for Amaryl) or Health Canada at the following addresses: Janssen-Ortho Inc. or Aventis Pharma Inc. Any suspected adverse incident can also be reported to: Canadian Adverse Drug Reaction Monitoring Program (CADRMP) The AR Reporting Form and the AR Guidelines can be found on the Health Canada web site or in The Canadian Compendium of Pharmaceuticals and Specialties. www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/adverse_e.pdf
(*) All trademark rights used under license from Johnson & Johnson. Amaryl is a registered trademark of Aventis Group. Used under licence by Aventis Pharma Inc., Laval, Quebec, H7L 4A8.
SOURCE: Janssen-Ortho Inc., Aventis Pharma Inc.
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