To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Drug Notification Issued For Pulmozyme (Dornase Alfa, Recombinant) Due To Packaging Defect URL: http://www.pslgroup.com/dg/18F182.htm Doctor's Guide March 14, 2000
MISSISSAUGA, ON -- March 14, 2000 -- Hoffmann-La Roche Limited announced that it is voluntarily issuing an important drug notification regarding a possible defect in the packaging of its cystic fibrosis drug, Pulmozyme(R) (dornase alfa, recombinant) Inhalation Solution. During a quality assurance inspection, the manufacturer (California-based Genentech, Inc.) discovered that a small puncture may be present in approximately one of every 1,700 ampules of Pulmozyme potentially causing it to leak. Hoffmann-La Roche Limited believes that the possible leaks are unlikely to cause adverse health effects since the product is refrigerated and given as a single dose. Hoffmann-La Roche Limited's product complaint and adverse event reporting systems have not revealed evidence of a change in the safety pattern of Pulmozyme as a result of the packaging defect. As well, no complaints of leaky ampules have been received by the company. Hoffmann-La Roche Limited is working with Health Canada and is in the process of informing wholesalers, pharmacies and physicians treating cystic fibrosis patients. The manufacturer has implemented corrective actions to prevent recurrence of this defect, and Hoffmann-La Roche Limited does not foresee a disruption in the product supply. Wholesalers and pharmacies should continue to distribute existing product. Hoffmann-La Roche believes that the leaks in ampules are readily identifiable. Physicians are asked to inform their patients to examine their Pulmozyme for potentially defective ampules. Patients should be instructed to examine all Pulmozyme ampules from this point forward for leaks by gently squeezing ampules prior to use. Ampules with leaks should not be used and should be returned to pharmacies. Pharmacies are requested to return affected ampules to Hoffmann-La Roche in Mississauga. Cystic fibrosis (CF) is an incurable inherited disease, affecting mainly the lungs and the digestive system. In the lungs, where the effects of the disease are most devastating, CF causes increasingly severe respiratory problems. In the digestive tract CF often results in extreme difficulty in digesting adequate nutrients from food. Pulmozyme is a recombinant human deoxyribonoclease I (rhDNase/dornase alfa). It is an inhaled medication that reduces CF-related morbidity, including the risk of respiratory tract infectious exacerbations requiring treatment with parenteral antibiotics, improves pulmonary function and improves quality of life. There are approximately 360 cystic fibrosis patients across Canada treated with Pulmozyme. Related Links: Pulmozyme (dornase alfa, recombinant), Hoffmann-La Roche Limited and Genentech, Inc. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.