HEADLINE NURSING NEWS

Nurses~4~Nurses FDA ALERTS The information reported in this section is from MedWatch, your Internet gateway for timely safety information on drugs and other medical products regulated by the U.S. Food and Drug Administration.  http://www.fda.gov/medwatch. Reprinted with permission. Listed in chronological order.

3/2/01 New Safety Information on Zyvox (linezolid) Myelosuppression (including anemia, leukopenia, pancytopenia and thrombocytopenia) has been reported in patients receiving linezolid.  Complete blood counts should be monitored weekly in patients who receive linezolid, particularly in those who receive linezolid for longer than two weeks, those with pre-existing myelosuppression, those receiving concomitant drugs that produce bone marrow suppression, or those with chronic infection who have received previous or concomitant antibiotic therapy.  A copy of the dear health professional letter may be found at: http://www.fda.gov/medwatch/safety/2001/safety01.htm#zyvox 3/5/01  Safety Update Miconazole Vaginal Cream This summary is to inform health care professionals that women who take a warfarin anticoagulant and use a miconazole intravaginal cream or suppository may be at risk for developing an increased prothrombin time, international normalized ratio (INR) and bleeding. Vaginal antifungal products containing miconazole will shortly have a new warning to advise consumers about the possibility of increased bleeding or bruising with concomitant warfarin use.  The FDA Science Background may be found at: http://www.fda.gov/cder/drug/infopage/miconazole/default.htm 3/14/01  Public Health Notice: Lead Exposure From Dental Film Stored Containers with Unpained Lead. There is a potential for harmful lead exposure from dental films stored in containers lined with unpainted lead. We believe that there may be hundreds of these lead-lined boxes currently being used to store dental films. Some of them may have been in use for decades. Most of these boxes are the size and shape of shoe-boxes, made of wood, and lined with lead that has apparently not been painted or coated. Dental films stored in these boxes have been found to be coated with a whitish film that is about 80% lead. In many cases there are highly dangerous levels of lead on the films, enough to potentially cause serious adverse health effects in patients and health care professionals. These adverse health effects include anemia and serious neurological damage. The complete FDA Public Health Notification Letter may be seen at: http://www.fda.gov/cdrh/safety/leadcontainer.html. 3/28/01 Pepcid Safety Labeling Changes Healthcare professionals are notified about the need for dosage adjustments for patients with moderate renal insufficiency [creatinine clearance <50ml/minute]. The previous labeling recommended adjustments for severe insufficiency only [creatinine clearance <10ml/minute].  Audience: Healthcare Professionals, particularly those caring for elderly patients in nursing home settings For details see our 2001 Safety Information page at: http://www.fda.gov/medwatch/safety/2001/safety01.htm#pepcid 3/28/01 Taxotere (docetaxel) Recall Audience: Wholesalers, hospital pharmacists, and oncology healthcare professionals.  Aventis Pharmaceuticals has initiated a voluntary recall of Taxotere® (docetaxel) for Injection Concentrate 20-mg active and diluent vials. The lot numbers for this recall are: 0P273 (active) which was packaged together with diluent vials with the following lot numbers: 0T446 (diluent) or 0T449 (diluent). It has been determined that the Taxotere 20mg vial containing the active ingredient may have inadvertently been labeled as a "diluent" vial.  Aventis has received one product complaint related to this mislabeling. The "Dear Healthcare Professional" and "Dear Wholesaler" letters published by Aventis can be seen on the MedWatch 2001 Safety Information page. Direct your web browser to: http://www.fda.gov/medwatch/safety/2001/safety01.htm#taxote 3/30/01 Raplon (rapacuronium) Recall Organon Inc. initiated a voluntary recall of Raplon® (rapacuronium bromide) for injection. Several serious adverse events, including bronchospasm and unexplained fatalities, were reported during postmarketing surveillance (in each of these cases the cause was unknown, as there were multiple drugs administered and other conditions present). The letter is part of a package distributed by the manufacturer and is posted on the MedWatch site: http://www.fda.gov/medwatch/safety/2001/raplon_DDL.htm 4/6/01 Nationwide Shortage of Naloxone HCl Audience: Hospital pharmacists, anesthesia providers and other healthcare professionals. Health care professionals are notified of a shortage of Naloxone HCl injection, a narcotic antagonist. This appears to be a temporary situation of two to three months in length. FDA has identified a temporary alternate supplier of Naloxone Hydrochloride Injection, USP in 0.4 mg/mL ampoules (1mL) and vials (10mL), as well as 1 mg/mL vials (2mL) effective April 4, 2001. Physicians and hospitals will be able to obtain this product via overnight delivery. This temporary program will not cover the pediatric strength of product (0.02 mg/mL). Supplies of this strength are available, but limited. For further information, read the FDA Shortage Alert at : http://www.fda.gov/medwatch/safety/2001/safety01.htm#naloxo MedWatch is your Internet gateway for timely safety information on drugs and other medical products regulated by the U.S. Food and Drug Administration.  Visit the MedWatch web site regularly for the latest official safety information, at http://www.fda.gov/medwatch Nurses Referral Banner Exchange Network- Powered by InterProSolution.com

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