TORONTO==Important Drug Notification Regarding Possible Packaging Defectgreenspun.com : LUSENET : Grassroots Information Coordination Center (GICC) : One Thread
HOFFMANN LA ROCHE LTD - Issues Important Drug Notification
Story Filed: Monday, March 13, 2000 5:57 PM EST
Toronto, Ontario, Mar. 13, 2000 (Market News Publishing via COMTEX) -- 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.
Questions regarding instructions and potentially defective ampules should be directed to Hoffmann-La Roche Limited Drug Information at 1-888-762-4388. All ampules should be inspected prior to use. Hoffmann-La Roche Limited is advising physicians that ampules without leaks may continue to be used by patients. Expired ampules should not be used.
Note to editors: 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.
TEL: (905) 542-5638 Media Contact: Josey Panetta, Manager, Corporate TEL: (905) 542-5638 Media Contact: Josey Panetta, Manager, Corporat Copyright ) 2000, Market News Publishing, all rights reserved.
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