Drug Topics - December 17, 2007 - (Page 15)

www.drugtopics.com DECEMBER 17, 2007 DRUG TOPICS 15 Rx Care Acne drug’s iPLEDGE program updated for more flexibility The risk management program to reduce the risk of fetal exposure to isotretinoin, iPLEDGE from Covance, has fully implemented program updates approved by the FDA in October. The revision will eliminate the 23-day lockout period when new prescriptions cannot be filled for females of childbearing age, and will thereby reduce interruptions in treatment while maintaining the rigor of the program. Changes to iPLEDGE were endorsed at a joint meeting of the agency’s Dermatologic and Ophthalmic Drugs and Drug Safety and Risk Management Advisory Committees in August 2007. The iPLEDGE program was implemented in March 2006 to minimize fetal exposure to the drug and closely monitor patients and their access to isotretinoin. The new changes can be viewed on-line at www.ipledgeprogram.com. tranasal formulation. The agency suggests that physicians consider other options for managing the condition. Desmopressin tablets can still be used to treat PNE; however, it is recommended that treatment be interrupted during episodes of fluid and/or electrolyte imbalance such as fever, vomiting, diarrhea, or vigorous exercise. In addition, fluid intake should be restricted from one hour before to eight hours after administration of desmopressin tablets. All desmopressin formulations should be used cautiously in patients at risk for water intoxication—e.g., patients with habitual or psychogenic polydipsia or patients taking tricyclic antidepressants and selective serotonin reuptake inhibitors. Cymbalta receives FDA OK for depression maintenance Eli Lilly & Co. has received regulatory word that antidepressant duloxetine Cymbalta, a reuptake inhibitor of both serotonin and norepinephrine, can now be marketed for the maintenance treatment of major depressive disorder (MDD) in adults. The supplemental approval was based on results of a trial of patients with MDD who received the drug once daily for 12 weeks and then were randomly assigned to either continue the drug or receive placebo for an additional six months. Patients who continued taking duloxetine experienced a statistically longer time to relapse of depression compared with those who took placebo. Cymbalta was previously approved to treat MDD, generalized anxiety disorder, and diabetic peripheral neuropathic pain. Two new guides summarize efficacy and safety of diabetes meds HHS’ Agency for Healthcare Research & Quality has developed two guides, one consumer-oriented and one for clinicians, that outline the latest scientific evidence on efficacy and safety of oral Type 2 diabetes medications. According to AHRQ, the new publications are the first to summarize the evidence that will help patients, their families, and healthcare providers make informed decisions about treating the condition. The consumer guide, entitled Pills for Type 2 Diabetes: A Guide for Adults, also includes information on medication costs, while the clinician’s version, Comparing Oral Medications for Adults With Type 2 Diabetes, provides confidence ratings for evidence to support research conclusions. The diabetes guides are part of the series of products from AHRQ’s Effective Health Care Program that are available on-line at http://effectivehealthcare. ahrq.gov/index.cfm Breast cancer drug gets extended patent protection Anastrozole (Arimidex, AstraZeneca) has been granted an additional six months of patent protection by the FDA under the agency’s pediatric exclusivity rule. The change came after the manufacturer performed clinical trials examining the use of anastrozole in children. Interestingly, the patent extension was still granted despite the fact that no therapeutic potential was found for anastrozole in the pediatric population and AstraZeneca will not seek an approval for an indication in children. Currently, anastrozole is approved for use in adults as first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor-unknown locally advanced or metastatic breast cancer, for adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer, and for treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. Enuresis indication removed from DDAVP due to hyponatremia The FDA has requested manufacturers of intranasal desmopressin to stop marketing the formulation for the treatment of primary nocturnal enuresis (PNE) after receiving 61 postmarketing reports of hyponatremicrelated seizures associated with use of the drug. Fiftyfive cases had reported sodium levels ranging from 104130 mEq/L during the seizure event, and two patients died. Thirty-six cases were associated with the in- Photo: Jim Shive >>> NEWS Roundup http://www.drugtopics.com http://www.ipledgeprogram.com/ http://www.ipledgeprogram.com/ http://effectivehealthcare.ahrq.gov/index.cfm http://effectivehealthcare.ahrq.gov/index.cfm

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Drug Topics - December 17, 2007 Contents Noncompete Clause: Help or Hindrance? Don't Overlook Feminine Care and Family Planning Independent Pharmacies Are Dreaming of a Green Christmas Latest News Roundup

Drug Topics - December 17, 2007

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