News Briefs
News Briefs
Janssen stops Propulsid marketing in U.S.
Janssen Pharmaceutica Inc. in Titusville, NJ, has voluntarily decided to stop marketing Propulsid (cisapride) in the United States effective July 14. The timing should provide a period during which patients and physicians can choose and initiate alternative treatment.
As of Dec. 31, 1999, Propulsid was associated with 341 reports of heart rhythm abnormalities, including 80 reports of deaths. Most of those adverse events occurred in patients who were taking concomitant medications or who were suffering from underlying conditions known to increase the risk of cardiac arrhythmia associated with Propulsid. Physicians treating patients for whom they believe the benefit of Propulsid outweighs the risk associated with taking it are encouraged to contact Janssen at 800-JANSSEN. The company will continue to make the drug available for patients meeting specific criteria for a limited-access protocol. The FDA Talk Paper on this subject can be viewed at www.fda.gov/bbs/topics/ ANSWERS/ANS01007.html.
New health book available
Health Data Sourcebook, a comprehensive manual that provides information regarding availability of hundreds of health care data sets from government agencies, associations, and commercial data vendors, has been released by NationsHealth Corp. in Memphis, TN.
The information in the manual is organized by categories, including demographic and psychographic data; vital statistics; health facilities; health professionals; need, demand, and utilization; and insurance and managed care. Within each category, a description of the data is presented, followed by a list of sources.
The book helps readers find, access, and evaluate available health care data. The book can be purchased for $95 by calling NationsHealth at (901) 276-3009. There is a money-back guarantee.
The goal of the corporation is to establish a national Internet-based warehouse of data. Information about the warehouse, expected to be fully operational by the middle of 2000, can be seen at www. nationshealthdata.com.
Vials made nonsterile
In a recent letter to health professionals and dialysis clinicians, Sherri L. Brown, MD, director and senior safety officer with Amgen Inc. in Thousand Oaks, CA, shared information about problems that have arisen with multiple use of labeled, single-use Epogen (epoetin alpha) vials. Twenty-one episodes of bacteremia or pyrogenic reactions were reported in patients receiving Epogen at a U.S. dialysis unit.
An investigation by the Centers for Disease Control and Prevention showed that unused Epogen remaining in single-dose preservative-free vials was collected and pooled into common vials for use in other patients. That led to extrinsic bacterial contamination of Epogen.
Amgen officials said that while multiple-dose vials of Epogen contain preservatives, single-dose vials do not. Therefore, once a needle has been introduced into the vial, the sterility of the product no longer can be guaranteed.
Further, Epogen labeling directs that unused portions of the drug from single-dose vials should be discarded. The text of Amgen’s letter can be viewed at www.fda.gov/medwatch/safety/2000/ safety00.htm#epogen. For additional information, call Amgen’s professional services department at (800) 772-6436.
Alpha blocker cited
The American College of Cardiology recommends that physicians discontinue use of an alpha blocker, Cardura (doxazosin), for treating hypertension. The recommendation follows a study by the National Heart, Lung, and Blood Institute that showed those receiving Cardura had 25% more cardiovascular events and were twice as likely to be hospitalized for heart failure than those receiving the diuretic chlorthalidone. Currently, about 1 million Americans take an alpha blocker to help control their hypertension.
New format available for MSDS database
Pharmacists track chemicals available at their institutions and maintain current Material Safety Data Sheets (MSDS) on those chemicals. Enterprise, FL-based SOLUTIONS Software’s MSDS database is now available in a new version for Windows. The database includes more than 250,000 generic and trade name chemicals. It is now available on a single DVD-ROM and has the ability to search by company, chemical abstracts service, trade name/product ID, ingredients, or any other field in any combination.
In addition, the data records contain all fields required by the Occupational Safety and Health Administration and the 16-part MSDS standard. The MSDS records and lists resulting from searches can be viewed on-screen, printed, or exported to disk files for additional processing. To order, call Richard Dunkel at (407) 321-7912 or e-mail [email protected].
NSAIDs in elderly increase risk of CHF
Use doubled odds of hospital admission
A study published in the March 27, 2000, issue of Archives of Internal Medicine shows that use of nonsteroidal anti-inflammatory drugs (NSAIDs) can exacerbate development of congestive heart failure (CHF).1 The authors performed a matched case-control study of the relationship between NSAID use and hospitalization with CHF. Cases (those admitted to hospitals with a primary diagnosis of CHF) and controls (those admitted to the same hospitals but without CHF) were interviewed for a thorough history of recent use of aspirin and other NSAIDs.
Results of the study show that recent use of NSAIDs in elderly cases (mean age 76.6 years, n=365) doubled the odds of hospital admission for CHF over that of controls (mean age 75 years, n=658). Both high dose and long plasma half-life of NSAIDs appear to increase the risk of CHF occurrence. In addition, the tendency of NSAIDs to antagonize the actions of diuretics and angiotensin-converting enzyme inhibitors may factor into the increased risk of CHF in elderly NSAID users. Also, there appears to be an increased risk in patients with a history of heart disease, even if that history did not include CHF.
Reference
1. Page J, Henry D. Consumption of NSAIDs and the development of congestive heart failure in elderly patients. Arch Intern Med 2000; 160:777-784.
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