June 19, 2007
Internal Medicine World Report, June 2007, Volume 0, Issue 0

First Bird Flu Vaccine

The first human vaccine in the United States that protects against the H5N1 influenza virus has been approved. The inactivated Influenza Virus Vaccine, H5N1 (Sanofi Pasteur) is indicated for persons 18 to 64 years of age who are at increased risk of exposure to the H5N1 virus subtype contained in the vaccine (A/Vietnam/1203/2004). www.fda.gov/cber/products/h5n1san 041707.htm

Novel Therapy for Paget's

Zoledronic acid (Reclast; Novartis) is the first treatment in nearly a decade to be approved for Paget's disease of the bone. Its active ingredient, zoledronic acid, marketed under the brand name Zometa (Novartis), is used to treat cancer-related bone problems. The new agent is administered as a single 15-mg, 15-minute IV infusion. Adverse events include mild-to-moderate flulike symptoms. www.novartis.com

Topical Rx for Impetigo

Staphylococcus aureus

Staphylococcus pyogenes

The first in a new class of prescription topical antibacterials, retapamulin ointment, 1% (Altabax; GlaxoSmithKline), has been approved for the treatment of impetigo from susceptible strains of or in adults and children ≥9 months of age (see Page 16). www.gsk.com

New Nasal Spray for Allergies

Once-daily fluticasone furoate (Veramyst; GlaxoSmithKline) nasal spray has been approved for seasonal and perennial allergy symptoms in adults and in children aged ≥2 years. The recommended starting dose is 110 μg (2 mists per nostril) once daily for patients ≥12 years. Common adverse reactions include headache, nosebleed, and nasal sores. www.gsk.com

Once-Daily Prefilled Insulin Pen

A new prefilled disposable pen (SoloStar; Sanofi-Aventis) for once-daily 24-hour insulin glargine (Lantus) has been approved for the treatment of patients with type 1 or type 2 diabetes. en.sanofi-aventis.com

Skin Patch for Early Parkinson's

The rotigotine transdermal system (Neupro; Schwarz) was approved to treat the signs and symptoms of early-stage Parkinson's disease. This nonergolinic dopamine agonist transdermal system delivers medication over a 24-hour period. The starting dose is 2 mg/24 h for 1 week, which can be increased to 4 mg/24 h for 1 week, if tolerated, to the maximum recommended dose of 6 mg/24 h. Adverse events include nausea, application-site reactions, somnolence, dizziness, headache, vomiting, and insomnia. www.neupro.com

Meningitis Treatment Gets Final Approval

Final approval has been granted to cytarabine liposome IV (DepoCyt; Enzon) for the treatment of lymphomatous meningitis. It was originally approved under the Accelerated Approval regulations of Subpart H of the Food, Drug, and Cosmetic Act. www.enzon.com

New Indications

  • Montelukast sodium 10 mg (Singular; Merck): for prevention of exercise-induced bronchoconstriction in patients ≥15 years. www.merck.com
  • Abatacept (Orencia; Bristol-Myers Squibb): to inhibit the progression of structural joint damage in adults with rheumatoid arthritis who have had an inadequate response to ≥1 disease-modifying antirheumatic drug. www.bms.com
  • Paliperidone (Invega; Janssen) extended-release tablets: for long-term maintenance treatment of schizophrenia. www.invega.com
  • Synthetic conjugated estrogens, B (Enjuvia; Barr): first oral estrogen approved for vaginal dryness, pain with intercourse, and vulvar and vaginal atrophy associated with menopause. A new 0.9-mg dosage was also approved. www.barrlabs.com
  • Dalteparin sodium injection (Fragmin; Eisai): for extended treatment of venous thromboembolism (VTE) and/or pulmonary embolism to reduce the risk of VTE recurrence in patients with cancer. www.frag min.com

New Dosages/Schedules

  • A 75-mg dose of risedronate sodium tablets (Actonel; Sanofi-Aventis) for osteoporosis, to be taken as 1 tablet on 2 consecutive days, for a total of 2 tablets monthly. www.actonel.com
  • Morphine sulfate extended-release (Kadian; Alpharma) in a 10-mg strength. www.kadian.com
  • A 5-day treatment course for gatifloxacin mesylate (Factive; Oscient) for mild-to-moderate community acquired pneumonia. www.oscient.com
  • A single, once-weekly tablet for alendronate sodium/cholecalciferol (Fosamax Plus D; Merck) containing alendronate sodium 70 mg and vitamin D3 5600 IU. www.merck.com

Drug Warnings

  • Acorda Therapeutics informed physicians that tizanidine (Zanaflex) is now contraindicated in patients taking the potent cytochrome (CY) P1A2 inhibitors fluvoxamine or ciprofloxacin (Cipro) to prevent increases in the serum levels of tizanidine, which can potentiate its hypotensive and sedative effects. Coadministration of tizanidine and other CYP1A2 inhibitors should be avoided. www.fda.gov/medwatch/ safety/2007/safety07.htm#Zanaflex
  • The FDA has ordered companies to stop manufacturing and distributing suppositories containing trimethobenzamide HCl, due to a lack of proven efficacy. The suppositories are marketed as Tigan, Tebamide, T-Gen, Trimazide, and Trimethobenz. Trimethobenzamide-containing oral capsules and injections are not affected. www.fda.gov/medwatch/safety/2007/safety07.htm#trimethobenzamide

New Conjunctivitis Therapy with Less Frequent Dosing

Azithromycin ophthalmic solution (AzaSite; Inspire) 1% has been approved for the treatment of bacterial conjunctivitis. The recommended dosing regimen is 1 drop twice daily for 2 days, followed by 1 drop daily for the next 5 days. The most common adverse effect is eye irritation. www.inspirepharm.com

Online Extra

Once-Yearly Treatment for Central Precocious Puberty

The histrelin acetate subcutaneous implant (Supprelin-LA; Indevus) has been approved for the treatment of central precocious puberty. The once-yearly implant releases approximately 65 ≥g/day of the gonadotropin-releasing hormone analog histrelin. The most common side effect is implant site reaction. www.indevus.com

Ambien Goes Generic

The first generic versions of zolpidem tartrate immediate-release tablets (Ambien; Sanofi Aventis) have been approved for the short-term treatment of insomnia. A total of 13 US drug manufacturers will be manufacturing the drug. www.fda.gov/cder/ogd/approvals