Rx report
2010; Wiley; Volume: 39; Issue: 4 Linguagem: Espanhol
10.1002/dat.20432
ISSN1932-6920
Tópico(s)Neuroendocrine Tumor Research Advances
ResumoDialysis & TransplantationVolume 39, Issue 4 p. 168-168 Rx ReportFree Access Rx report† First published: 19 April 2010 https://doi.org/10.1002/dat.20432 † The author writes “Rx Report” for D&T, and is a clinical pharmacist at New York Downtown Hospital. She is based in New York, New York. AboutSectionsPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat New Approvals Liraglutide injection (Victoza) has finally received approval from the Food and Drug Administration (FDA). It is a once-daily glucagon-like peptide-1 (GLP-1) receptor agonist, similar to exenatide, to treat adults with type 2 diabetes mellitus (T2DM) as an adjunct to diet and exercise.1 Liraglutide has been studied in more than 3,900 patients, and the most common side effects are headache, nausea, and diarrhea. Pancreatitis may also occur and clinicians should look out for signs and symptoms, such as abdominal pain, nausea, and/or vomiting to rule out pancreatitis as a cause. In clinical trials, liraglutide was not found to have an increased risk of cardiovascular events in patients that were at a low risk of developing these events. Post-marketing safety studies are ongoing. Due to unknown safety issues, particularly with regards to findings of thyroid tumors in animals, liraglutide is available with a risk evaluation and mitigation strategy (REMS) and medication guide. In addition, until the safety of this agent is clearer, it is not considered a first-line treatment. Liraglutide should be used with caution in patients with mild to severe renal impairment, including end-stage renal disease (ESRD), and presently there are no dose adjustments recommended for patients with renal impairment.2 This renal information is in contrast to exenatide, which should not be used in patients with severe renal impairment or ESRD.3 In the Pipeline Ceftobiprole, an antibiotic under investigation for treatment of complicated skin and skin structure infections including diabetic foot infections, has had another setback at the FDA.4 Ceftobiprole is a broad-spectrum, anti-methicillin-resistant Staphylococcus aureus (MRSA) cephalosporin with activity against MRSA, penicillin-resistant Streptococcus pneumonia, and many important gram-negative bacteria, including Pseudomonas. The FDA has questioned the validity of two trials and has asked the manufacturer to complete two new trials.5 The manufacturer believes that if they continue to investigate this agent, it would not be able to enter the U.S. market for at least another three years. Enoxaparin, a generic version of Lovenox is being investigated and hopes to soon garner FDA approval.6 Novartis is optimistic about their version of this blockbuster drug, but cannot predict a timeline for approval. Other companies investigating generic versions include Teva Pharmaceutical Industries, Watson Pharmaceuticals, and Amphastar Pharmaceuticals. Hematide, a PEGylated peptide that binds to and activates the erythropoietin receptor acting as an erythropoiesis stimulating agent (ESA), has completed follow-up in Phase 3 clinical trials. These trials involved approximately 2,600 patients at roughly 400 clinical sites. The results of these four studies (two each of patients “on” and “not on” hemodialysis) are expected to be reported sometime this quarter. Studies compared the safety and efficacy of Hematide versus darbepoetin alfa for managing anemia and maintaining hemoglobin levels over time.7 Ultra rapid-acting insulin powder for inhalation (Afrezza) was originally supposed to be reviewed by the FDA by the middle of January, but has been delayed.8 This insulin product is pH sensitive and achieves peak insulin levels within 12 to 14 minutes of administration, mimicking mealtime insulin levels seen in non-diabetics. The submitted new drug application (NDA) includes treatment for patients with both type 1 and 2 diabetes. Recalls The FDA has recalled more than two million Huber needles (Nipro Medical Corporation, distributed by Exelint International Corporation) which are used mostly in port implants in hospital/clinic or home-based settings.9 This Class 1 recall, the most serious recall type, was instituted because 60% to 70% of the needles “cored,” which could enter patients veins damaging the port and/or local tissue. The FDA stated that up to this time, there has only been leakage at the port site. Anyone using these products needs to stop immediately and return unused needles to Exelint (www.exelint.com). In the Literature According to Infection Control Today, more than 13,000 healthcare-associated infections (HAIs) occurred and were reported in Pennsylvania hospitals in the second half of 2008. According to the Centers for Disease Control (CDC), there are about 1.7 million infections in the U.S. each year, which lead to approximately 99,000 deaths.10 Yet, many of these infections are preventable. In Pennsylvania, legislation known as the “Reduction and Prevention of Health Associated Infection in Long-Term Care Nursing Facilities Act” was passed to try and decrease HAIs in healthcare institutions. Two specific infection types evaluated were central-line bloodstream infections (CLABSI) and catheter-associated urinary infections (CAUTI). In the future, surgical site infections will also be evaluated. The report showed that in the evaluated timeframe, there was a rate of 2.84 HAIs per 1,000 hospitalization days. About one-third of the hospitals that used urinary catheters and central lines had more CAUTI and CLABSI than expected. However, when compared with the rest of the nation, the rates were actually lower. The CDC estimates that HAIs cost an excess of $30 billion to healthcare systems yearly, so preventing any unnecessary illness and death is better for patients, healthcare systems, and everyone's wallets. References 1 Bobo EG., FDA website. FDA approves new treatment for type 2 diabetes. Published January 25, 2010. Available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm198638.htm Accessed January 26, 2010. 2Victoza label. FDA website. Published January 25, 2010. Available at: www.accessdata.fda.gov/drugsatfda_docs/label/2010/022341lbl.pdf Accessed January 26, 2010. 3Byetta label. FDA website. Published October 30, 2009. Available at: www.accessdata.fda.gov/drugsatfda_docs/label/2009/021773s9s11s18s22s25lbl.pdf Acc-essed January 27, 2010. 4Johnson & Johnson website. FDA issues complete response letter for ceftobiprole. Published December 30, 2009. Available at: www.jnj.com/connect/news/all/20091230_090000 Accessed January 26, 2010. 5 Dennis M., FDA requests further studies of Johnson & Johnson, Basilea's ceftobiprole. Published December 31, 2009. Available at: www.firstwordplus.com/Fws.do?articleid=CFDD09CAEDA048DD83C8EAEE86E9B859&logRowId=343108 Accessed January 26, 2010. 6UPDATE 1-Novartis optimistic on generic Lovenox approval. Published January 26, 2010. Available at: www.reuters.com/assets/print?aid=USLDE60P17120100126 Access-ed January 27, 2010. 7Affymax website: Affymax completes treatment and last patient follow-up in phase 3 program for investigational drug, hematide(TM), to treat anemia in chronic renal failure. Published January 25, 2010. Available at: www.investors.affymax.com/releasedetail.cfm?ReleaseID=439620 Accessed January 26, 2010. 8 MannKind Corporation website., MannKind updates status of new drug application. Published January 8, 2010. Available at: www.news.mannkindcorp.com/phoenix.zhtml?c=147953&p=irol-newsArticle&ID=1373077&highlight= Accessed January 27, 2010. 9 Young S., FDA recalls more than 2 million needles used in port implants. Published January 27, 2010. Available at: www.cnn.com/2010/HEALTH/01/26/needles.recall/?hpt=T2 Accessed January 27, 2010. 10HAIs topped 13,000 in second half of 2008, Pennsylvania Department of Health Reports. Published January 18, 2010. Available at: www.infectioncontroltoday.com/hotnews/pennsylvania-hais-reported.html Accessed January 27, 2010. Volume39, Issue4April 2010Pages 168-168 ReferencesRelatedInformation
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