Drug Topics - March 31, 2008 - (Page 7) 7 Rx Care DTaP vaccine gets FDA nod for fifth dose Sanofi-Pasteur’s Daptacel vaccine, containing diphtheria and tetanus toxoids as well as acellular pertussis vaccine adsorbed, has been approved by the Food and Drug Administration for the fifth consecutive dose in the DTaP series for childhood vaccination. According to Centers for Disease Control and Prevention recommendations, five doses of DTaP should be administered before a child reaches the age of seven. The approval was based on a trial involving 487 children at 22 different sites who received Daptacel as a fifth dose. Results indicated a booster response was achieved in 93% of patients to each of the pertussis components and antibody responses were achieved in 100% of patients for both the tetanus and diphtheria antigens. Daptacel was previously approved in 2002 for four consecutive doses of DTaP currently administered at 2, 4, 6, and 15 , to 20 months of age. with darunavir as well as ongoing monitoring throughout therapy. AST/ALT lab values should be monitored in patients with underlying chronic hepatitis, those with elevated transaminases, and/or cirrhosis. Interruption or discontinuation of darunavir should be considered if there is evidence of new or worsening liver dysfunction. Questions should be directed to Tibotec Therapeutics Medical Information at 1-(877)-732-2488. Misuse of Tussionex leads to ADR reports, FDA warning The Food & Drug Administration has issued a warning to practitioners on the appropriate use of Tussionex Pennkinetic Extended-Release Suspension, containing hydrocodone. Reports received by the agency have revealed that physicians and other healthcare professionals are inappropriately prescribing the medication, leading to serious adverse events in some cases, including death. The FDA warning reminds practitioners that the cough suppressant is not to be administered any more frequently than every 12 hours and is contraindicated in children less than six years old. In addition, prescribers should consult the prescribing information to determine an accurate dose, and should instruct patients not to take the cough medicine any more frequently than every 12 hours, using a medicine syringe for measuring the dose rather than a household teaspoon or tablespoon. According to the FDA, the alert does not impact the short-acting cough products containing hydrocodone that can be given every four to six hours; however, the agency is currently reviewing safety information on these other products and will provide updates as new information becomes available. Tussionex Pennkinetic is manufactured by UCB Inc. Feds seeking comments to hydroxyurea draft brief The National Institute of Environmental Health Sciences (NIEHS) has issued a draft brief on hydroxyurea. Hydroxyurea is used in the treatment of cancer, sickle cell disease, and thalassemia. The draft brief covers the findings of an expert panel which met last year to discuss this topic. This substance was chosen for evaluation because it is cytotoxic and may contain adverse reproductive effects. NIEHS wants comments to the draft to be received by May 1. Liver toxicity warning added to Prezista PI Clinical trial and postmarketing reports of drug-induced hepatotoxicity have led Tibotec Pharmaceuticals to update the prescribing information for darunavir (Prezista). Drug-induced hepatitis was reported in 0.5% of patients taking the protease inhibitor in combination with ritonavir during the clinical development program and, according to Tibotec, postmarketing cases of liver injury, including some fatalities, have since been reported. In general, the cases occurred in patients with advanced HIV-1 disease taking multiple other medications, with immune reconstitution syndrome, and those patients having co-morbidities such as hepatitis B or C coinfection. The update includes recommendations for appropriate laboratory testing prior to initiating treatment Government and Law DEA exempts six anabolic steroids from its regulatory control The Drug Enforcement Administration has exempted six Schedule III anabolic steroid products from classification under the Controlled Substances Act (CSA). The six products are esterified estrogens and methyltestosterone tablets in various dosages from Interpharm, Inc., Lannett Co., and ANDAPharm, LLC. DEA explained that it’s waiving CSA requirements for these products because they are similar to other products that have been exempted and they don’t seem to be associated with any abuse. This final rule, published in the March 17 Federal Register, takes effect on April 16. DT >>> NEWS Roundup
Table of Contents Feed for the Digital Edition of Drug Topics - March 31, 2008 Drug Topics - March 31, 2008 Contents NCPDP Eyeing Standards for e-MARs for Nursing Home Patients GPhA: Tackling Key Issues of the Day New Products Latest News Roundup Drug Topics - March 31, 2008 Drug Topics - March 31, 2008 - Contents (Page 1) Drug Topics - March 31, 2008 - Contents (Page 2) Drug Topics - March 31, 2008 - NCPDP Eyeing Standards for e-MARs for Nursing Home Patients (Page 3) Drug Topics - March 31, 2008 - GPhA: Tackling Key Issues of the Day (Page 4) Drug Topics - March 31, 2008 - GPhA: Tackling Key Issues of the Day (Page 5) Drug Topics - March 31, 2008 - New Products (Page 6) Drug Topics - March 31, 2008 - Latest News Roundup (Page 7)
For optimal viewing of this digital publication, please enable JavaScript and then refresh the page. If you would like to try to load the digital publication without using Flash Player detection, please click here.