Pharmacy & Therapeutics - February 2008 - (Page 90)

NEW DRUGS pression, especially during sleep. Either effect is likely to be potentiated by specific drugs used concomitantly with methadone. It is possible that some patients might have died from synergistic or potentiated effects of other drugs. Because many people benefit from methadone, a large prospective evaluation of methadone therapy is warranted. The researchers also recommend additional safeguards for methadone treatment, such as an electrocardiogram and assessment of the potential for respiratory depression. (Source: Am J Med 2008;121:66–71.) DRUG NEWS after receiving a valid prescription. In these cases, the practitioner has decided that the patient has special medical needs that cannot be met by FDA-approved drugs. Patients should consult their health care providers to determine whether compounded drugs are their best option. If patients or practitioners encounter problems with these compounded products, they can file a report with MedWatch at www.fda.gov/medwatch. (Sources: FDA, January 9, 2008; www. fda.gov/cder/pharmcomp/default.htm; www.fda.gov/consumer/updates/bio identicals 010908.html.) risks and benefits of using ESAs for patients with chemotherapy-induced anemia in the next few months. ESAs are indicated for treating anemia in patients with chronic kidney failure; for cancer patients with anemia caused by chemotherapy; and for patients with human immunodeficiency virus (HIV) infection when anemia results from zidovudine (AZT). ESAs are also used to reduce the number of transfusions during and after major surgery. (Source: FDA, January 3, 2008.) FDA Challenges Bio-identical Hormones The FDA has warned seven pharmacy operations that their claims about the safety and effectiveness of their bioidentical hormone replacement therapy (BHRT) products are not supported by medical evidence. The FDA letters state that the pharmacy operations have violated federal law by making false claims. These operations claim that their drugs, which contain hormones such as estrogen, progesterone, and estriol, are superior to FDA-approved menopausal hormone therapy drugs and that they prevent or treat Alzheimer’s disease, stroke, and cancer. However, estriol is not a component of any FDA-approved drug and has not proved safe or effective. The companies imply that their drugs are natural or “identical” to the hormones made by the body and state that their products are better than FDA-approved menopausal hormones. The agency does not review compounded drugs for safety and effectiveness, and it encourages patients to use FDA-approved drugs whenever possible. Firms that do not address the violations in the warning letters risk seizure of their drugs. The FDA is not targeting pharmacists who practice traditional pharmacy compounding, in which a pharmacist prepares a drug for a patient More Studies Suggest Risks of Anemia Drugs The FDA is reviewing new data from two studies that suggest further evidence of the risks of er ythropoiesisstimulating agents (ESAs). Patients with breast or advanced cer vical cancers who received these drugs to treat anemia caused by chemotherapy died sooner or had more rapid tumor growth than similar patients who did not receive an ESA. These two recent studies are in addition to the six studies described in the earlier revised labeling approved by the FDA in November 2007. The boxed warnings and labeling changes concerned Amgen’s Aranesp and Epogen and Ortho-Biotech/J&J’s Procrit in cancer patients (see Drug News, page 644, in the December 2007 issue of P&T). All eight studies showed more rapid tumor growth or shorter survival when patients with breast, non–small-cell lung, head and neck, lymphoid, or cer vical cancer received ESAs, compared with patients not receiving this treatment. In all of these recent studies, ESAs were given in an attempt to achieve a hemoglobin level of 12 g/dL or greater, although many patients did not reach that level. The FDA plans to revisit the Label Update For Ortho Evra Birth Control Patch The FDA has approved more changes to the labeling of Ortho-McNeil’s Ortho Evra Contraceptive Transdermal Patch. In a new epidemiologic study, patients were at higher risk of developing venous thromboembolism (VTE) than women using oral birth control tablets. The label changes are based on a study conducted by the Boston Collaborative Drug Sur veillance Program on behalf of Johnson & Johnson. The patch was studied in women 15 to 44 years of age. These recent findings supported an earlier study that also said women in this group were at higher risk for VTE. The patch, applied once weekly, releases ethinyl estradiol (estrogen) and norelgestromin (a progestin hormone) through the skin into the bloodstream. Women using the product are exposed to about 60% more estrogen than if they use typical birth control pills containing 35 mcg of estrogen. Increased levels of estrogen may raise the risk of side effects, including VTE. The FDA considers Ortho Evra safe and effective when it is used according to the labeling. (Sources: FDA, Ortho, Januar y 18, 2008.) 90 P&T® • February 2008 • Vol. 33 No. 2 http://www.fda.gov/medwatch http://www.fda.gov/cder/pharmcomp/default.htm http://www.fda.gov/cder/pharmcomp/default.htm http://www.fda.gov/consumer/updates/bioidenticals010908.html http://www.fda.gov/consumer/updates/bioidenticals010908.html

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Pharmacy & Therapeutics - February 2008 Contents Editorial Medication Errors Prescription: Washington The Language of (Forgive Us) Change, As P&T Enters the Digital Age New Drugs/Drug News/New Medical Devices Drug Forecast Use and Outcomes of Antifibrinolytic Therapy in Patients Undergoing Cardiothoracic Surgery at 20 Academic Medical Centers in the United States Evaluation of the Management of Acute Venous Thromboembolism and Its Outcomes: One Institution's Experience American Society of Hematology, 49th Annual Meeting Pharmaceutical Approval Update

Pharmacy & Therapeutics - February 2008

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