Diabetes Treatment OKd for First-Line Treatment
Rosiglitazone maleate-metformin (Avandamet) is now approved as initial treatment for type 2 diabetes-an adjunct to diet and exercise to improve glycemic control. Avandamet, a product of GlaxoSmithKline, was previously approved as a second-line therapy for use in patients who were not controlling their diabetes on metformin therapy. Avandamet is the only combination of a thiazolidinedione, rosiglitazone maleate, and metformin to be approved as an initial therapy for type 2 diabetes.
Avandamet is available in four tablet strengths of rosiglitazone/ metformin, respectively: 2 mg/500 mg, 4 mg/500 mg, 2 mg/1,000 mg, and 4 mg/1,000 mg.
Avandamet is contraindicated in people with renal disease or renal dysfunction and acute or chronic metabolic acidosis. Avandamet should not be used in patients with liver problems. Consult product labeling for additional specific prescribing information.
Single-Rod Implantable Contraceptive Approved
Organon's single-rod etonogestrel subdermal implantable contraceptive (Implanon) has been approved by the FDA. The 68 mg etonogestrel implant is about the size of a matchstick and is inserted just beneath the skin of the inner upper arm during an in-office procedure. Removal can occur at any time, after which fertility returns to normal.
Implanon continuously releases a low, steady dose of progestin for up to 3 years; it has been shown to be 99% effective.
Organon will be sponsoring a national clinical training program for healthcare providers on insertion and removal procedures beginning in late 2006. Only healthcare providers trained through the Organon-sponsored programs can order Implanon. Implanon will become more widely available in 2007 as the training program progresses.
As with any progestin-only contraceptive, users of Implanon can experience irregular bleeding. Other adverse events associated with the contraceptive include headache, acne, dysmenorrheal, and emotional lability. Implant site complications were experienced by 3.6% of study participants and included redness, swelling, hematoma, and pain. Removal complications were also low (1.7%).
Therapy for Parkinson's Dementia
The FDA approved rivastigmine tartrate (Exelon, Novartis Pharmaceutical Corp.) capsules and oral solution for the treatment of mild-to-moderate dementia associated with Parkinson's disease. The drug was previously approved for the treatment of mild-to-moderate dementia of the Alzheimer's type.
The FDA based the approval on data from a clinical trial of 541 patients who showed symptoms of mild-to-moderate dementia 2 years or later after being diagnosed with Parkinson's disease. At the end of the 24-week trial, the condition of the patients treated with rivastigmine was significantly better than the condition of the patients treated with placebo.
Clinical trials of rivastigmine showed the drug was associated with significant gastrointestinal reactions: 47% of patients using the medication developed nausea and 26% of women and 18% of men on high doses of rivastigmine experienced significant weight loss.
CDC Recommends Second Varicella Inoculation
The Advisory Committee on Immunization Practices (ACIP) to the Centers for Disease Control and Prevention (CDC) voted to recommend a second dose of varicella vaccine for children 4 to 6 years old to further improve protection against the disease.
According to the CDC, 15% to 20% of children who received one dose of the vaccine are not fully protected and may develop varicella after coming in contact with varicella zoster virus. Additionally, one dose of vaccine may not continue to provide protection into adulthood, when chickenpox is more severe. A second dose of varicella vaccine provides increased protection against varicella disease compared with one dose.
The ACIP also recommended that children, adolescents, and adults who previously received one dose of varicella vaccine should receive a second dose.