July 20, 2007
Internal Medicine World Report, July 2007, Volume 0, Issue 0

Long-Term Beta2-Agonist for COPD

The beta2-agonist formoterol fumarate (Perforomist; Dey), the first nebulized form of formoterol, has been approved for long-term, twice-daily maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD). The recommended dosage is 20 ?g/2 mL (1 vial) every 12 hours. Reported adverse events are diarrhea, nausea, nasopharyngitis, dry mouth, vomiting, dizziness, and insomnia. www.perforomist.com

New Oral Rx for Allergic Rhinitis, Chronic Hives

Levocetirizine dihydrochloride (Xyzal; UCB/Sanofi-Aventis) has been approved as a once-daily oral treatment for allergic rhinitis and for uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children aged ≥6 years. The recommend dosages are 5 mg/day (1 tablet) in the evening for adults and children ≥12 years of age, and 2.5 mg/day (half tablet) in the evening for children 6 to 11 years of age. Adverse events include somnolence, nasopharyngitis, fatigue, dry mouth, and pharyngitis in those ≥12 years; and pyrexia, somnolence, cough, and epistaxis in younger children. www.ucb-group.com

Estradiol Gel for Hot Flashes

Estradiol gel 0.1% (Divigel; Upsher-Smith) has been approved for moderate-to-severe menopausal hot flashes. The estrogen is derived from plant sources and matches the primary estrogen produced by a woman's ovaries before menopause. Patients should start with the lowest dose, generally 0.25 g/day. Side effects are those known with all estrogen products. www.divigelus.com

First OC Combo Halts Menses

The first low-dose combination oral contraceptive (OC) taken 365 days a year, without a placebo phase or pill-free interval, has been approved. Lybrel (90 ?g levonorgestrel/20 ?g ethinyl estradiol) provides steady, low-dose hormones that may allow women to become cycle-free. Studies showed no delay in return to fertility/menses. www.wyeth.com

Oral Therapy for Pulmonary Arterial Hypertension

Ambrisentan (Letairis; Gilead Sciences) has been approved to improve exercise capacity and delay disease progression in patients with pulmonary arterial hypertension who have WHO Functional Class II or III symptoms. The recommended initial dosage of 5 mg/day can be increased to 10 mg. Side effects include leg and ankle edema, nasal congestion, sinusitis, and facial flushing. The product will be available through the Letairis Education and Access Program, a restricted distribution program designed to help patients learn about the risks of Letairis, which include liver injury and birth defects. www.letairis.com

New Test for Aspirin Efficacy

The AspirinWorks Test Kit (Corgenix), an enzyme-linked immunoassay for determining levels of 11-dehydrothromboxane B2 in human urine, has been approved to aid in detecting the effect of aspirin in apparently healthy patients. www.aspirinworks.com

7-Day Glucose Monitoring System

The STS-7 Continuous Glucose Monitoring System (STS-7 System; DexCom), which measures glucose levels every 5 minutes for up to 7 days in patients with diabetes, has been approved. It uses a disposable sensor placed just below the skin in the abdomen to measure the level of glucose in interstitial fluid. The sensor, which must be replaced weekly, can be easily inserted by the patient with minimal discomfort. An alarm can be programmed to sound if a patient's glucose level reaches preset lows or highs. A 3-day version of the device was approved in March 2006. www.dexcom.com

FDA Alerts

False Claims about OxyContin

Physicians have received false information about the prescription pain reliever OxyContin from the manufacturer Purdue Frederick, claiming the agent does not cause euphoria and is less addictive than immediate-release opiates or morphine, the FDA says. www.fda.gov/medwatch/safety/2007/safety07.htm#OxyContin

MRI Contrast Agents Containing Gadolinium

The FDA has asked manufacturers to include a new boxed warning on the product labeling of all gadolinium-based contrast agents used to enhance magnetic resonance imaging, stating that it puts patients with severe kidney insufficiency at risk for nephrogenic systemic fibrosis (NSF). Patients should be screened for kidney problems before receiving any of the 5 gadolinium-based contrast agents available in the United States. The recommended dose should not be exceeded, and sufficient time allowed for 1 dose to be eliminated before another dose is given. There are no reports of NSF among those with normal kidney function or with mild-to-moderate kidney insufficiency. www.fda.gov/cder/drug/infopage/gcca/default.htm

Online Extra

New Indications

  • Quetiapine fumarate extended release (Seroquel XR; AstraZeneca) for the once-daily treatment of schizophrenia in adults.
  • Tinidazole (Tindamax; Mission) oral treatment for bacterial vaginosis. www.missionpharmacal.com
  • Enoxaparin sodium injection (Lovenox; Sanofi-Aventis), a low-molecular-weight heparin, for the treatment of patients with acute ST-segment elevation myocardial infarction. www.sanofi-aventis.us
  • Doxorubicin HCl liposome injection (Doxil; Ortho Biotech) in combination with bortezomib (Velcade; Millennium) for injection to treat patients with multiple myeloma who have previously received at least 1 therapy other than bortezomid. www.doxil.com

FDA Warns of Counterfeit Drugs from Internet Sellers

The FDA has issued a warning about the dangers of buying prescription drugs over the Internet, based on information the agency received showing that 24 apparently related websites may be involved in the distribution of counterfeit prescription drugs.

It appears that these websites are being operated from outside of the United States. Physicians should warn their patients to be wary if there is no way to contact the website pharmacy by phone, if prices are dramatically lower than the competition, or if no prescription from a physician is required. They should also instruct their patients to check www.fda.gov/buyonline for additional information before buying prescription drugs over the Internet.

The 24 websites include:

  • www.AllPills.net
  • www.Pharmacy-4U.net
  • www.DirectMedsMall.com
  • www.Brandpills.com
  • www.Emediline.com
  • www.RX-ed.com
  • www.RXePharm.com
  • www.Pharmacea.org
  • www.PillsPharm.com
  • www.MensHealthDrugs.net
  • www.BigXplus.net
  • www.MediClub.md
  • www.InterTab.de
  • www.Pillenpharm.com
  • www.Bigger-X.com
  • www.PillsLand.com
  • www.EZMEDZ.com
  • www.UnitedMedicals.com
  • www.Best-Medz.com
  • www.USAPillsrx.net
  • www.USAMedz.com
  • www.BluePills-Rx.com
  • www.Genericpharmacy.us
  • www.I-Kusuri.jp

This list is posted at: www.pharmacycall365.com.