- Imiquimod cream 5% (generic Aldara)1
- Losartan tablets (generic Cozaar)2
- Losartan/hydrochlorothiazide tablets (generic Hyzaar)2
New Drugs, Indications, Approval Recommendations
- Olmesartan medoxomil (Benicar) has been approved by the FDA for treating hypertension in patients ages 6 to 16.3 It has been approved for treating hypertension in adults since 2002.
- Late last year, the prescribing information for rasagiline (Azilect) was updated to remove restrictions related to dietary tyramine ingestion (known as the “cheese reaction”), and removal of restrictions related to concomitant use of sympathomimetic amines (e.g., phenylephrine, pseudoephedrine, ephedrine, etc.) when used at the recommended doses of 0.5 mg and 1 mg.4,5
- Rifaximin (Xifaxin) has been approved by the FDA for treating hepatic encephalopathy.6 Twice-daily use of rifaximin 550 mg maintains remission from hepatic encephalopathy more effectively than placebo over a six-month period and significantly reduces the risk of hospitalization.7 In this study, more than 90% of patients also received lactulose. Rifaximin also has been approved by the FDA for treating travelers’ diarrhea.
- Earlier this year, rosuvastatin (Crestor) became the first statin to garner FDA approval for primary prevention of cardiovascular disease.8 Patients who might benefit from primary prevention include men 50 years or older and women 60 years or older with a fasting LDL <130 mg/dL, a highly-sensitive C-reactive protein level of greater than 2 mg/L, a triglyceride level lower than 500 mg/dL, and no prior history of stroke, myocardial infarction, or coronary heart-disease risk.
- Fingolimod (FTY720, Gilenia), a once-daily oral disease modifying therapy for the treatment of multiple sclerosis, has been granted a priority review by the FDA. 9 The New Drug Application (NDA) was accepted in December 2009, but a priority review decreases the standard 10-month review to six months. The timeframe, however, could be extended to evaluate a risk evaluation and mitigation strategy (REMS) program. This sphingosine 1-phosphate receptor (S1P-R) has been shown to significantly reduce both relapses and disability progression (compared with placebo) in patients with relapsing remitting multiple sclerosis.
- Oral bisphosphonates: On March 11, the FDA posted information related to a possible connection between the use of bisphosphonates and the risk of developing atypical sub-trochanteric femur fractures.8 Two weeks later, a study and accompanying editorial described how there is no link between bisphosphonates and femur fractures.10,11 As of press time, the FDA had not commented on the study results.
- Clopidogrel has received a boxed warning related to decreased effectiveness when administered to patients who are poor metabolizers of the agent.12 Approximately 2% to 14% of the U.S. population are poor metabolizers due to a variation in CYP2C19 liver enzyme function. The warning includes information for prescribers about genetic testing for patients to identify those who might be poor metabolizers of clopidogrel; the information should assist providers with decision-making on the most appropriate therapy.
- Erythropoiesis-stimulating agents (ESAs): The FDA is requiring all ESAs to be prescribed and used under a REMS program to ensure their safe use.13 The measures were put in place after studies showed that ESA use can increase the risk of tumor growth and shorten survival in oncology patients. Only hospitals and healthcare professionals who enroll and complete specific training in the REMS program (known as ESA APPRISE Oncology) will be able to prescribe and dispense ESAs to healthcare professionals. All patients prescribed ESAs for any indication must receive a copy of the medication guide when the drug is dispensed. For prescribers using ESAs for noncancer indications (e.g., anemia related to HIV, chronic kidney disease patients, etc.), enrollment in the REMS program is not required; however, a medication guide must be given to patients when the drug is dispensed. For more information, visit www.esa-apprise.com/.
- Ritonavir (Norvir) and saquinavir (Invirase) combination and cardiac effects: The FDA is evaluating preliminary data that indicate the combined use of ritonavir and saquinavir might lead to prolongation of the QT and PR interval of the electrocardiogram, and might lead to Torsades de Pointes or heart block.14 Any patients receiving both of these agents should be evaluated for such symptoms as lightheadedness, fainting, or arrhythmias. The risk of arrhythmias may be increased in patients with a history of QT interval prolongation.
- Increased risk of muscle injury with high-dose simvastatin: The FDA has identified that the highest dose of simvastatin (80 mg) is associated with a greater risk of muscle injury, including rhabdomyolysis.15 The concern with simvastatin is as a single ingredient, and as part of combinations with ezetimibe or niacin. The FDA will publish a report when the review has been completed. TH
Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.
- Fougera announces first generic approval of imiquimod cream 5% (Rx), equivalent to Aldara. Fougera website. Available at: http://www.fougera.com/news/release_detail.asp?id=1057. Accessed March 5, 2010.
- Dane L. US court ruling restores Teva’s marketing exclusivity for generics of Merck & Co. hypertension drugs. FirstWord website. Available at: http://www.firstwordplus.com/Fws.do?articleid=A9C69CCA747746D2832D25A523C54E63&logRowId=353155. Accessed March 23, 2010.
- FDA approves Benicar for the treatment of high blood pressure in children and adolescents aged 6-16. Available at: http://www.dsi.com/news/pdfs/FINAL_Benicar_Pediatric_Approval_Press_Release.pdf. Accessed March 23, 2010.
- FDA approves newly revised prescribing information for Azilect reducing medication and food restriction. Teva website. Available at: http://www.tevaneuroscience.com/NewsContent.aspx?Ispreview=No&Type=News&Id=251&Status=Current. Accessed March 23, 2010.
- Tilyou S. Tyramine-rich foods and rasagiline not always a bad mix. Pharmacy Practice News website. Available at: http://www.pharmacypracticenews.com/index.asp?section_id=50&show=dept&issue_id=618&article_id=14885. Accessed March 25, 2010.
- Drew J. FDA approves Salix drug Xifaxan as treatment for hepatic encephalopathy. Triangle Business Journal website. Available at: http://triangle.bizjournals.com/triangle/stories/2010/03/22/daily41.html?t=printable. Accessed March 25, 2010.
- Bass NM, Mullen KD, Sanyal A, et al. Rifaximin treatment in hepatic encephalopathy. N Engl J Med. 2010;362(12):1071-1081.
- Peck P, Agus ZS. FDA okays statin for primary prevention. MedPage Today website. Available at: http://www.medpagetoday.com/tbprint.cfm?tbid=18380. Accessed March 23, 2010.
- Novartis oral multiple sclerosis development compound Gilenia (FTY720) granted US priority review status. Novartis website. Available at: http://www.novartis.com/newsroom/media-releases/en/2010/1386852.shtml. Accessed March 23, 2010.
- Oral bisphosphonates: ongoing safety review of atypical subtrochanteric femur fractures. U.S. Food and Drug Administration website. Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm204127.htm. Accessed March 24, 2010.
- Black DM, Kelly MP, Genant HK, et al. Bisphosphonates and fractures of the subtrochanteric or diaphyseal femur. N Engl J Med. 2010 Mar 24.
- Shane E. Evolving data about subtrochanteric fractures and bisphosphonates. N Engl J Med. 2010 Mar 24.
- Dane L. FDA adds boxed warning to Plavix to advise of reduced effectiveness in some patients. FirstWord website. Available at: http://www.firstwordplus.com/Fws.do?articleid=7AD8DC1985644F1683D822FE7C1EC2B4&logRowId=355395. Accessed March 24, 2010.
- Drug safety communication: erythropoiesis-stimulating agents (ESAs): Procrit, Epogen and Aranesp. U.S. Food and Drug Administration website. Available at: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm200297.htm. Accessed March 24, 2010.
- Jefferson E. FDA Announces Possible Safety Concern for HIV Drug Combination Published February 23, 2010 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm201552.htm. Accessed March 24, 2010.