Drug Topics - March 24, 2008 - (Page 6) 6 DRUG TOPICS MARCH 24, 2008 www.drugtopics.com > > > NEWS Roundup Rx Care Go-ahead granted for Wyeth’s antidepressant Pristiq Desvenlafaxine (Pristiq), an antidepressant from Wyeth Pharmaceuticals, has been approved for marketing as a treatment for major depressive disorder in adults. The serotonin-norepinephrine reuptake inhibitor (SNRI) does not require titration, according to the manufacturer, and is approved as a once-daily 50-mg dose. Desvenlafaxine delivers the active metabolite venlafaxine (Effexor XR, Wyeth) in its active state without first going through the CYP2D6 metabolic pathway. Wyeth has agreed to conduct several postmarketing studies in several areas: relapse prevention, pediatrics, sexual dysfunction, lower dosing, and a non-clinical toxicity study. Wyeth said the new product will be rolled out during the second quarter of 2008. sy, 46 for multiple sclerosis, 82 for Alzheimer’s disease, 58 for brain tumors, 35 for sleep disorders, 171 for pain, and 30 for Parkinson’s disease. Reports of neuropsychiatric events lead Roche to update Tamiflu warning Roche Laboratories has updated its prescribing information for oseltamivir (Tamiflu) capsules and oral suspension as a result of recommendations made by the Food & Drug Administration Pediatric Advisory Committee last November. There have been postmarketing reports of delirium and abnormal behavior leading to injury and death in some cases, in patients with influenza infection who were also taking oseltamivir. The events occurred mostly in pediatric patients and often had an abrupt onset and rapid resolution. However, whether or not their occurrence was due to the drug or influenza itself has not been established, according to Roche. In addition, a new statement has been added to the Patient Information for oseltamivir that describes an increased risk of seizures, confusion, or abnormal behavior early during the influenza illness, which may occur shortly after beginning oseltamivir. Most of the neuropsychiatric reports received were from Japan. Oseltamivir is indicated for the treatment of uncomplicated acute illness due to influenza in patients one year and older who have been symptomatic for no more than two days. Adverse reaction reports may be submitted to the FDA by calling 1-(800)-526-6367 or at www.fda.gov/medwatch. NAA once again calls on FDA to remove mercury from vaccines, rethink schedule A case of autism that developed after a child received nine vaccines in one day has prompted the National Autism Association (NAA) to once again appeal to the FDA to remove all mercury-containing vaccines from the market. The NAA has long believed that the mercury contained in preservative thimerosal leads to the subsequent development of autism. In addition, NAA is now urging federal health agencies to examine the recommended childhood immunization schedule to determine if vaccinating children with so many shots in such a short period of time is safe and to evaluate its cumulative effect. According to NAA, one in 150 children is diagnosed with autism. Aloxi OK’d for post-op emesis Palonosetron (Aloxi, Eisai) has been approved for a new indication. The 5-HT3 receptor antagonist can now be used for the prevention of postoperative nausea and vomiting (PONV) for up to 24 hours following surgery. In a Phase III study involving 574 patients undergoing elective gynecologic or abdominal laparoscopic surgery, palonosetron achieved the co-primary endpoint of complete response — no vomiting or use of rescue medication for the first 24 hours after surgery. Palonosetron has been available since 2003 and is also approved for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately and severely emetogenic chemotherapy. PhRMA report lists 547 neurological drugs in development The Pharmaceutical Research and Manufacturers of America (PhRMA) has released a report stating that 547 drugs are in the pipeline for the treatment of neurological diseases and the population most likely to benefit from their development is Hispanics. According to PhRMA, diseases such as lupus, epilepsy, stroke, and Alzheimer’s disease disproportionately affect more Hispanics than other ethnic groups. Among the new entities being studied, 23 are for stroke, 26 for epilep- Government and Law Congress mulling whether to move human growth hormone to Schedule III Should human growth hormone be classified as a Schedule III controlled substance? That’s what Con- http://www.drugtopics.com http://www.fda.gov/medwatch
Table of Contents Feed for the Digital Edition of Drug Topics - March 24, 2008 Drug Topics - March 24, 2008 Contents Medical Communication: Pharmacy's Best Kept Secret Pharmacies Bemoan Generics' Shrinking Margins More Groups Demand Pathway For Biogenerics Latest News Roundup Drug Topics - March 24, 2008 Drug Topics - March 24, 2008 - Contents (Page 1) Drug Topics - March 24, 2008 - Contents (Page 2) Drug Topics - March 24, 2008 - Medical Communication: Pharmacy's Best Kept Secret (Page 3) Drug Topics - March 24, 2008 - Pharmacies Bemoan Generics' Shrinking Margins (Page 4) Drug Topics - March 24, 2008 - More Groups Demand Pathway For Biogenerics (Page 5) Drug Topics - March 24, 2008 - Latest News Roundup (Page 6) Drug Topics - March 24, 2008 - Latest News Roundup (Page 7)
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