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Generic Aricept Approved for AD-Related Dementia  In December, The U.S. Food and Drug Administration (FDA) approved the first generic versions of Aricept (donepezil hydrochloride) orally disintegrating tablets. Donepezil hydrochloride is indicated for the treatment of dementia related to Alzheimer disease (AD). “Generics offer greater access to health care for all Americans,” said Gary Buehler, director of the FDA's Office of Generic Drugs. “Health care professionals and consumers can be assured that FDA-approved generic drugs have met the same rigorous standards as the brand-name drug and are the same as the branded in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use.” Dementia refers to a decline in cognitive function that interferes with daily life and activities. AD starts in a region of the brain that affects recent memory, and then gradually spreads to other parts of the brain. The generic donepezil hydrochloride orally disintegrating tablets have been approved in 5- and 10-mg strengths. For more information, go to www.fda.gov/Drugs/ResourcesForYou/ucm167906.htm. FDA Issues Warning about Epilepsy Drug's Effects on Fetuses The FDA reminds health care professionals about the increased risk of neural tube defects and other major birth defects, such as craniofacial defects and cardiovascular malformations, in babies exposed to valproate sodium and related products (valproic acid and divalproex sodium) during pregnancy. The FDA is working with the manufacturers of these products to address labeling changes. Health care practitioners should inform women of childbearing potential about these risks and consider alternative therapies, especially if using valproate to treat migraines or other conditions not usually considered life-threatening. Women of childbearing potential should only use valproate if it is essential to manage their medical condition. Those who are not actively planning a pregnancy should use effective contraception, as birth defect risks are particularly high during the first trimester, before many women know they are pregnant. For more information, refer to http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm192649.htm. New Drug for Long-Term Pain Relief after Shingles Attacks Gets Green Light The FDA has approved Qutenza (capsaicin) 8% patch, a medicated skin patch that relieves the pain of post herpetic neuralgia (PHN), a serious complication that can occur after a bout with shingles. Shingles is an outbreak of rash or blisters on the skin that is caused by the varicella-zoster virus, the same virus that causes chickenpox. Anyone who once had chickenpox is at risk of shingles because the virus may become reactivated years after the initial infection. PHN is a condition affecting nerve fibers and the skin, which can cause excruciating pain for weeks, months, or even years. About 10% to 15% of patients who have shingles experience PHN, and the complication is even more common in elderly patients. Qutenza contains capsaicin, a compound found in chili peppers. Although there are over-the-counter products with lower concentrations of capsaicin that are marketed for the treatment of PHN, Qutenza is the first pure, concentrated, synthetic capsaicin-containing prescription drug to undergo FDA review and was approved on November 16. The most frequently reported adverse drug reactions included pain, swelling, itching, redness, and bumps at the application site. Qutenza must be applied to the skin by a health care professional because placement of the patch can be quite painful, requiring use of a local topical anesthetic and additional pain relief such as ice or opioid pain relievers. The patient must also be monitored for at least 1 hour because there is a risk of a significant rise in blood pressure after patch placement.
FDA Approves Cymbalta for Generalized Anxiety Disorder In November, the FDA approved Cymbalta (duloxetine HCl) for the maintenance treatment of generalized anxiety disorder (GAD) in adults. “Since generalized anxiety disorder can be a chronic illness, it is important that doctors and their patients find a treatment option that is effective in both the acute and maintenance phase of treatment,” said James M. Martinez, MD, U.S. Medical Director for Cymbalta. “With this additional approval, Cymbalta offers a new option for the maintenance treatment of this often-debilitating condition.” The drug's efficacy and safety for the maintenance treatment of GAD were established in a double-blind, placebo-controlled trial. Patients with GAD who had initially responded to treatment with 60 to 120 mg/day of Cymbalta during a 26-week, open-label phase were randomly assigned to receive 60 to 120 mg/day (216 patients) Cymbalta or placebo (213 patients). At the end of the trial, patients taking Cymbalta experienced a statistically significantly longer time to relapse of GAD than did patients taking placebo. The most commonly reported treatment-emergent adverse events included nausea, headache, dry mouth, diarrhea, dizziness, constipation, fatigue, and increased sweating. Cymbalta is also approved for the acute and maintenance treatment of major depressive disorder, the management of diabetic peripheral neuropathic pain and fibromyalgia, and the acute treatment of GAD all in adults. For full prescribing information, including boxed warning and medication guide, visit http://www.cymbalta.com. Preventive Services Task Force Updates Depression Guidelines The U.S. Preventive Services Task Force (USPSTF) has issued new guidelines for depression screening in adults that underscores the necessity of staff-assisted care for positive outcomes. The following statements were taken from a clinical summary of the recommendation. The recommendation itself is available at www.ahrq.gov/clinic/uspstf09/adultdepression/addeprrs.htm.
•This document is a summary of the 2009 recommendation of the USPSTF on screening for depression in adults. It is intended for use by primary care clinicians. This summary was first published in Annals of Internal Medicine in December 2009 (Ann Intern Med. 2009;151:791).
•Persons at increased risk for depression are considered at risk throughout their lifetime. Groups at increased risk include persons with other psychiatric disorders, including substance misuse; persons with a family history of depression; persons with chronic medical diseases; and persons who are unemployed or of lower socioeconomic status. Also, women are at increased risk compared with men. However, the presence of risk factors alone cannot distinguish depressed patients from nondepressed patients.
•Simple screening questions may perform as well as more complex instruments. Any positive screening test result should trigger a full diagnostic interview using standard diagnostic criteria. The optimal interval for screening is unknown. In older adults, significant depressive symptoms are associated with common life events, including medical illness, cognitive decline, bereavement, and institutional placement in residential or inpatient settings.
•Limited evidence suggests that screening for depression in the absence of staff-assisted depression care does not improve depression outcomes. “Staff-assisted depression care supports” refers to clinical staff who assist the primary care clinician by providing some direct depression care or coordination, case management, or mental health treatment.
Related USPSTF recommendations on screening for suicidality and screening children and adolescents for depression are available at www.preventiveservices.ahrq.gov. For a summary of the evidence systematically reviewed in making these recommendations, the full recommendation statement, and supporting documents, go to http://www.preventiveservices.ahrq.gov. FDA Approves Zyprexa Relprevv for Schizophrenia in Adults The FDA has approved Zyprexa Relprevv (olanzapine) for extended-release injectable suspension for the treatment of schizophrenia in adults. The long-acting intramuscular injection sustains the delivery of olanzapine for up to 4 weeks. Different from both oral and injected short-acting formulations, long-acting formulations of antipsychotics allow for stable concentrations of the active drug to remain at a therapeutic range for an extended period of time. Proper treatment for schizophrenia can relieve symptoms, prevent or delay relapse, and break the revolving door cycle often associated with schizophrenia. Nonadherence to antipsychotic medications greatly increases the risk of relapse in patients with schizophrenia. By administering long-acting medications, psychiatrists know when patients have received their medication and can immediately detect nonadherence when a patient does not return for a scheduled injection. The approval is based on a broad clinical data package involving 2054 patients in which Zyprexa Relprevv was found to be effective in controlling symptoms of schizophrenia, including: hallucinations, delusions, apathy, and social withdrawal. Efficacy was shown without the need for oral supplementation. Clinical data showed that 150-, 210-, 300-, and 405-mg dosages provide therapeutic olanzapine exposure for 2 or 4 weeks, depending on the dose. Lilly worked with the FDA to develop a risk evaluation and mitigation strategy (REMS) that includes a communication plan, a patient medication guide, and a mandatory patient care program, which restricts distribution to prescribers, health care facilities, pharmacy service providers, and patients enrolled in the program. The goal of the program is to mitigate the risk of negative outcomes. Full prescribing information, including boxed warnings, is available at www.zyprexarelprevv.com. Investigators Recommend Ultrasound to Detect Breast Lumps Researchers from the University of Washington found that breast ultrasounds detected 100% of suspicious cancers in women younger than 40 who had lumps or other suspicious areas in their breasts. Ultrasounds offer a cheaper, less invasive option to surgery or biopsy. Constance Lehman teaches at the university and is Director of Imaging at the Seattle Cancer Care Alliance. According to a December 2 Reuters article, “Lehman did two studies testing the effectiveness of ultrasound to distinguish between potentially cancerous lumps and harmless masses in younger women. In one, they studied more than 1100 ultrasound exams of women under age 30. In the second, they studied 1500 exams in women age 30 to 39. In both studies, ultrasound correctly identified the cancers and all of the benign breast changes. The only cancer not found was in a region of the breast that was not identified as an area of concern. Instead, it was identified by a full breast mammogram.” Lehman also said the United States lacks a standard way to treat women in this age group who find a lump. The article quoted her as saying, “Some of them go to the operating room to have the lump removed. Others have it followed. Others have a needle biopsy, and we wanted to bring some clarity to this treatment.” Furthermore, she said, “Ultrasound is a quick and easy test that uses sound waves to create an image of the breast. It typically costs $100 to $200 per exam.” Lehman said, “using ultrasound could help balance some of the harms of overtreatment with the benefits of self breast exams in women under age 40, who are too young for routine mammogram screening even under the American Cancer Society guidelines.” Read the full article at http://www.reuters.com/article/idUSTRE5B13YB20091202. PII: S1555-4155(10)00028-0 doi:10.1016/j.nurpra.2010.01.007 | |
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